The We Run This City (WRTC) Youth Marathon Program is a community-supported, school-based fitness program designed to increase physical activity in a large, urban school district by engaging middle school youth to train 12 to 14 weeks to run or walk 1.2 miles, 6.2 miles, or 13.1 miles of the Rite Aid Cleveland Marathon. The objective of our study was to evaluate the effect of the intervention on adolescent health.We assessed changes in obesity, health, and fitness, measured before training and postintervention, among 1,419 sixth- to eighth-grade students participating in WRTC for the first time, with particular interest in the program’s effect on overweight (85th–94th body mass index percentile) or obese (≥95th percentile) students. We collected data from 2009 through 2012, and analyzed it in 2016 and 2017. Outcomes of interest were body mass index (BMI), waist-to-hip ratio (WHR), elevated blood pressure, and fitness levels evaluated by using the Progressive Aerobic Cardiovascular Endurance Run (PACER) test and the sit-to-stand test.P < .001). WHR increased among obese participants, whereas reductions in blood pressure among those with elevated blood pressure were associated with higher amounts of training and lower baseline BMI.We saw significant improvements overall in fitness and blood pressure. Controlling for demographics, program event, and training dosage, BMI percentile increased among normal weight participants and decreased among overweight and obese participants (Even small amounts of regular physical activity can affect the health and fitness of urban youths. School–community partnerships offer a promising approach to increasing physical activity by supporting schools and making a school-based activity inclusive, fun, and connected to the broader fitness community. More than one third of adolescents in the United States are overweight or obese, and rates of obesity are significantly higher among racial/ethnic minority youths and in economically disadvantaged communities –3. DecreThe WRTC program is a school-based youth fitness program in Cleveland, Ohio, developed by a multiorganization collaborative led by the YMCA of Greater Cleveland. It is implemented across a large metropolitan school district where most (85%) students are from racial/ethnic minority groups and from low-income households. The program was designed to address the declining levels of school-based physical education across the school district, where only 20% of middle school students were receiving daily physical education and more than 40% of middle school youth were considered overweight or obese .The WRTC program encourages middle school youths (grades 6–8) at varying fitness levels to adopt active, healthy lifestyles and to engage in a goal-oriented activity: to train in a graduated manner over 12 to 14 weeks to run or walk a segment of 1.2 miles, 6.2 miles (10K), or 13.1 miles  of the Rite Aid Cleveland Marathon. We examined the effect of the WRTC program on body mass index (BMI) and other body measurements, on blood pressure, and on overall fitness. A secondary aim was to examine the program’s impact on students who were overweight or obese before enrolling in the program.We used a nonexperimental pretest–posttest study design to examine the effect of the WRTC program by aggregating WRTC program evaluation data collected from 2009 through 2012, which we analyzed in 2016 and 2017. No reference group was available. Data were derived from all first-time participants enrolled in the program from 2009 through 2012 , representing 60.4% of all WRTC participants and involving 35 schools. These aggregated data consisted of samples of 387 students in 2009, 407 in 2010, 452 in 2011, and 173 in 2012. Annual participation in the program at the school level varied, with 57% of schools participating for 1 to 2 years and 43% participating for 3 to 4 years. However, we included only first-time participants on each team in our analyses. Team sizes ranged from 2 to 72 students. Parental consent and student assent for study and program participation were obtained. The institutional review board of Case Western Reserve University approved the study.WRTC recruitment began in the fall of each year. Teams, typically led by a physical education teacher, were formed within schools and were composed of students with a range of fitness levels, athletic ability, and body composition. Other school personnel  also led or assisted with teams. Coaches were responsible for scheduling and leading practices, collecting training data, and ensuring that their teams attended prerace events . Training for the 10K or the half marathon event  began in January; training for the 1.2-mile event started mid-February. Race day is always the third Sunday of May.The goal of training was to help participants safely build up to running their chosen event, allowing each student to progress at his or her own pace. Because of safety concerns , most teams trained on school property either by running several laps around the gymnasium, creating a short course throughout school hallways, or running the perimeter of school grounds outdoors. Typically, trainings focused on endurance  rather than distance.Coaches were given a training curriculum, and trainings were held a minimum of 2 to 3 days per week depending on the event: 1.2-mile event participants trained twice per week and 10K/half participants trained at least 3 times per week. For both groups, the goal was to reach at least 25 miles of training before race day; however, the 10k/half participants were expected to log in at least 3 times that amount of training when including the required out-of-school practice races. Training focused on walking and running but also included sessions on nutrition , injury prevention, getting adequate sleep, and game-like activities . Training materials were developed by the YMCA and were drawn from national fitness initiatives such as Let’s Move . Teams aAs part of the program design, all students who completed 20 training miles would earn a pair of good-quality running shoes; however, in practice, nearly all participants received running shoes. Students who remained in the program until race day received free race registration, T-shirts, and an official medal. Coaches received a small stipend ($100–$300) at the conclusion of the program. Program size and incentives varied from year to year, depending on the level of external funding secured by the program.The evaluation team consisted of trained research staff of the Prevention Research Center for Healthy Neighborhoods and community partners, including school nurses, nursing and nutrition students, and YMCA fitness staff. Team members were trained and observed in their assigned protocol. The assessments took place at the YMCA 1 to 2 weeks before the beginning of training and again 1 to 2 weeks following race day.2). BMI percentile was calculated by using BMI-for-age growth charts, which are different for boys and girls, and then categorized at baseline as normal weight (<85th percentile), overweight (85th–94th percentile), or obese (≥95th percentile) . Height was measured to the nearest 0.1 cm by using a free-standing portable stadiometer . Weight and height were measured twice, and the average of the 2 measurements was used to calculate BMI. We calculated BMI as weight in kilograms divided by the square of the height in meters (kg/mcentile) .We calculated waist-to-hip ratio (WHR) as the average waist measurement (cm) divided by the average hip measurement (cm). Higher ratios are an indicator of visceral fat around the abdomen, which is associated with cardiovascular disease, hypertension, and diabetes ,20. MeasBy using a nationally recommended protocol  and DuraWe used the sit-to-stand test to assess lower-extremity endurance and strength . SittingWe used the Progressive Aerobic Cardiovascular Endurance Run (PACER) test, a multistage fitness test adapted from the 20-meter shuttle run test , to evalTraining dosage was measured as the total distance walked, jogged, or run during the 12- to 14-week training period. Before the program, routes within and outside the school grounds were measured by the coach and YMCA staff. Coaches documented distance completed, measured in tenths of a mile, after each training session, and they calculated accumulated mileage.P < .05.We analyzed the data by using SPSS version 19 (IBM Corp). For elevated blood pressure, we examined proportional differences by using the McNemar test; for all other outcomes, repeated measures analysis of covariance (ANCOVA) were conducted with age, sex, and race/ethnicity as covariates. Both within-subject effects (change across time) and between-subject differences based on event , training dosage (number of miles), and baseline BMI category were examined. Significance was set at The average age of participants was 13 years. Approximately half were male, and the racial/ethnic distribution was largely minority with 66% black, 13% Hispanic/Latino, 14% white, and 7% other race  . At baseP < .001) and fewer were obese (P = .03) than those in the lost to follow-up group, but did not differ by sex or race/ethnicity. When stratified by training event, only age was significant (followed students were younger) within the 1.2-mile event; no differences were found within the 10K/half event group. Primary reasons for withdrawing from the program or not attending the evaluation assessments, as reported by the coaches, were academic concerns, behavioral issues on the team or in school, transportation problems, illness, or injury.Of students assessed at baseline, 67.3% completed the postintervention assessment. Overall, followed students were younger (P = .051), obese participants logged fewer miles than did either overweight or normal-weight participants. However, 39% of obese participants logged more than 25 miles of training, compared with 49% of normal-weight participants and 48% of overweight participants. We saw no difference in training levels between male and female participants.Approximately half of participants met the goal of training 25 miles before the race . BecauseP = .02) and completed nearly 8 more laps in the PACER test (P < .001) than they did at baseline .We observed significant improvements in both the sit-to-stand and the PACER test; on average, participants completed the sit-to-stand test 0.72 seconds faster . A significant interaction was also found for WHR, but in this case, a change was observed only in obese participants, and it was an increase in WHR rather than a decrease . In the final set of analyses for all 4 indicators , the models were rerun, controlling for event and training dosage. The results  (P < .001). Similarly, as the number of miles of training increased, the proportion with reductions in elevated blood pressure increased, from 72.7% for those with less than 15 miles of training to 77.8% for those with 15 to 24 miles and 85.7% for those with 25 or more miles of training. However, new cases of elevated blood pressure within the 15 to 24 miles group made the gains nonsignificant. With regard to BMI category, both normal weight and overweight participants showed significant improvements . However, this was not the case for obese participants. Although 70% of those with elevated blood pressure at baseline had normal blood pressure postintervention, 30% continued to have elevated blood pressure and an additional 19 students  had elevated blood pressure at postintervention. Moreover, even when participating at the highest training level (≥25 miles), only 73% of those with elevated blood pressure had normal blood pressure postintervention compared with 91% of overweight and 88% of normal weight peers. An additional 18% of these highly active but obese adolescents had elevated blood pressure after the intervention even though they had normal blood pressure at baseline.In the nonstratified analyses, of the 137 participants with elevated blood pressure at baseline, 81.0% had readings in the normal range at postintervention, a substantial reduction even in light of the 6.8% of new cases of elevated blood pressure among the previously normal group ( < .001) . This efOver the past decade, the amount of time during the school day dedicated to physical education has decreased dramatically. Simultaneously, the rate of obesity has grown exponentially. Both of these trends are markedly higher in economically disadvantaged communities and communities of color such as the one involved in this study. For these reasons, our study results provide promise. All participants, regardless of obesity status, appeared to have gained strength and endurance, as indicated in the 2 fitness measures. Overweight participants appeared to have benefited the most: increases in fitness, decreases in BMI, and improved heart health via normalized blood pressure, a result found by others . Obese pAdolescents with obesity might find a school-based fitness program unwelcoming and daunting. However, when programs are developed to be inclusive and fun, we found that many overweight and obese students can and will stick to a moderate-to-vigorous physical activity program in their schools. The results also highlight the difficulty in retaining these most at-risk youth, as obese participants were more likely to drop out of the program compared with their peers.This study also highlights the challenge of making a marked and sustained difference for adolescents who are already at the high end of the BMI charts. The increase in the WHR and the nonsignificant impact on blood pressure in this group suggests a complex physiologic interplay between physical activity, blood pressure, and visceral adiposity . ModeratWe presume that part of the success of WRTC is due to the nature of a school–community partnership. In this case, the WRTC coaches are school personnel and the program is conducted during the school day, but tremendous support and resources are supplied by community partners. These partners not only support the school coaches but also provide the structure and financial backing for the program. As a result, the WRTC program appears to offer a unique experience: an opportunity that allows students to be physically active with friends and not just those in their gym class, perhaps allows them to interact with their teacher/coach in a different way than in a classroom setting, provides an opportunity to travel to different parts of the city for practice races and trainings, and has them run as a registered “runner” on race day with thousands of other runners, not to mention the experience of hearing thousands cheering as they cross the finish line. While unique, this program is one that should be replicable in other cities with a community race event and willing partners.The lack of a comparison group as well as the cross-sectional study design are the primary limitations of this study. Without a comparison group, we cannot be certain that some of the improvements, particularly the fitness tests, were not due to a practice effect. Also, a longitudinal study of program participants would determine the effects of participation over several years and would strengthen support of this already successful program.This study provides some evidence that the high rates of obesity could be reduced somewhat, or at least abated, if schools reinstated more frequent physical education programming during the school day, especially in districts where regular physical education has been drastically reduced over the past decade. One approach to bridging this gap is through strong, committed partnerships between schools and communities.


Popliteal cyst commonly presents as an ellipsoid mass with uniform low signal intensity on T1-weighted magnetic resonance images and high signal intensity on T2-weighted images. Here, we describe a popliteal cyst with unusual appearance on magnetic resonance imaging, including heterogeneous intermediate signal intensity on T2-weighted images. Arthroscopic cyst decompression revealed that the cyst was filled with necrotic synovial villi, indicative of rheumatoid arthritis. Arthroscopic enlargement of unidirectional valvular slits with synovectomy was useful for the final diagnosis and treatment. Popliteal cyst, or Baker's cyst, is commonly seen in patients with rheumatoid arthritis . It is eA 74-year-old man was referred to our hospital with a 2-month history of a painful mass in the popliteal fossa of the right knee. The patient had undergone conservative treatment for a diagnosis of osteoarthritis of the right knee for the previous 4 months at a nearby clinic. The patient was 158 cm tall and weighed 58 kg and demonstrated a limp due to right knee pain. He had emphysema and carcinoma of the stomach, both of which were well controlled.On physical examination of the right knee, an elastic soft mass measuring 5 cm × 3 cm with a smooth surface was palpable in the popliteal fossa. The mass was tender on palpation without redness or warmth. Range of motion was −10° of extension and 120° of flexion due to contracture. Tenderness was elicited on the medial joint line. McMurray's test was positive with pain on the medial joint line, but a clicking sound was not elicited. Patellar ballottement also was positive. No anteroposterior or lateral instability was observed. Laboratory data revealed a C-reactive protein level of 1.26 mg/dL and a haemoglobin level of 12.9 mg/dL but were otherwise within normal range. Blood examinations pertaining to rheumatoid arthritis were not performed at the initial visit. Plain radiographs of the right knee showed grade 2 medial compartment osteoarthritis. MRI revealed a well-defined popliteal mass with low signal intensity on T1-weighted images and heterogeneous intermediate signal intensity on T2-weighted images Figures . The cysArthroscopic surgery under general anaesthesia was performed. Synovial proliferation was observed in the suprapatellar pouch and gutters of both sides, which were excised. To access the popliteal cyst, a transseptal portal was made after creating posteromedial and posterolateral portals using our technique . SynoviaRange of motion of the right knee and weight-bearing gait were allowed from 2 days postoperatively. Postoperative blood examinations revealed positive results for rheumatoid factor and an anticyclic citrullinated peptide antibody level of 78.1 U/mL. The final diagnosis was popliteal cyst filled with necrotic synovia accompanied by rheumatoid arthritis. No swelling, deformity, or tenderness was found in other joints, including the contralateral knee, fingers, elbows, or shoulders. Administration of methotrexate 6 mg/week was started after surgery. MRI performed 1 year postoperatively showed no evidence of the popliteal cyst . At 2 yePopliteal cyst, or Baker's cyst, is caused by a one-way valvular mechanism of the slits between the medial head of the gastrocnemius muscle and the semimembranosus muscle . On MRI,In addition to rheumatoid arthritis, popliteal cysts can be caused by many other underlying pathologies . AnatomiConservative therapy including antirheumatic drugs is the first choice of treatment for popliteal cyst with rheumatoid arthritis. However, we could not diagnose this patient with rheumatoid arthritis preoperatively. According to previous reports, open excision of popliteal cyst results in a high rate of recurrence . Arthros


There is a significant need for strategies to increase access to evidence-based interventions for children with autism spectrum disorder (ASD). One novel approach is to train parents to use evidence-based interventions for their child with ASD via telehealth. Pilot work examining the efficacy of one such program, ImPACT Online, demonstrated a high rate of parent program engagement, low attrition, and associated gains in parent learning and child social communication.The objective of this study was to conduct an open trial of ImPACT Online to better understand its dissemination potential.We examined the reach and representativeness of families who registered (n=36) compared to families who were referred (n=139) to the open trial for one referral site. We then compared the demographics of all families who enrolled in the open trial (n=112) to families who enrolled in one of two controlled trials of the same program (n=50). We also examined metrics of program engagement for the open and controlled trials, the relationship between program engagement and changes in parents’ intervention knowledge, and program evaluation for the participants in the open trial.t160=5.22, P<.001. Parents in the open trial engaged with the program at a significantly lower rate than the controlled trial, F3,81=21.14, P<.001. Program engagement was significantly associated with gains in parent intervention knowledge across both the groups, beta=.41, t=2.43, P=.02. Participants in the open access trial evaluated the program highly, but several barriers were noted.In total, 25.8% (36/139) of the parents who were given information about the program at their child’s diagnostic feedback session registered with the program. The parents who enrolled in the open (OT) and controlled trials (CT), respectively, were similar in gender (OT: 84.8% (95/112); CT: 88% (44/50), female), marital status (OT: 80.4% (90/112) ; CT: 69.6% (32/46), married), education (OT: 58.0% (65/112); CT: 54.0% (27/50), college degree or higher), and employment status (OT: 58.0% (65/112); CT: 65.3% (32/49), employed outside the home). The child participants were similar in terms of gender (OT: 83.0% (93/112); CT: 76.0% (38/50), male) and race and ethnicity (OT: 38.4% (43/112); CT: 24.0% (12/50), minority). However, the mean chronological age of the child participants in the open trial group was significantly higher (Mean=60.0 months) than in the controlled trial group (Mean=43.0 months), with These data suggest that additional strategies may need to be developed to support families in using telehealth-based parent-mediated intervention in community settings. Autism spectrum disorder (ASD) is a chronic and pervasive neurodevelopmental disorder characterized by deficits in social communication and the presence of restricted and repetitive behaviors . IndividParent-mediated intervention is one cost-effective and ecologically valid way to increase access to evidence-based ASD intervention. Numerous studies have established that parents can be successfully taught to use evidence-based strategies to improve their child’s social-communicative functioning . AdditioAlthough there has been growing interest in using telehealth to deliver parent-mediated intervention for children with ASD, empirical evaluations of such programs are limited. Several recent studies have demonstrated the initial efficacy of evidence-based, parent-mediated autism interventions when delivered by computer or over the internet, with or without therapist assistance -17. One Self-directed telehealth interventions do not require a trained professional and can typically be administered at a much reduced cost. Thus, they have a strong dissemination potential  and may In addition, it is not clear whether the high rates of program engagement observed in our pilot trial of ImPACT Online would be observed in participants who openly enroll in the program. Attrition rates during open trials of self-directed telehealth interventions are often much higher than those found in controlled trials of the same intervention, in which potential participants are closely screened, monitored, and “pushed” to continue engaging with the program by the research staff . For exaHighly efficacious programs that have a limited reach or low quality implementation are not likely to have a significant impact on public health . TherefoThis study conducted an open trial of ImPACT Online to better understand the dissemination potential of a self-directed, telehealth-based, parent-mediated intervention for families of children with ASD. Specifically, we examined (1) the reach and representativeness of a subset of families who enrolled in the open trial, (2) the demographics of families who enrolled in the open trial compared to families who enrolled in one of our two controlled trials of the same program, 3) metrics of program engagement for the open and controlled trials, (4) the relationship between program engagement and changes in parents’ intervention knowledge, and (5) program evaluation for the open trial.Participants in the open trial group (n=112) were parents of a child with ASD between the ages of 27 and 152 months who self-enrolled through the ImPACT Online website. To be included in the analyses, the participant had to identify as the child’s mother, father, or step-parent, live in the United States, be proficient in English, and complete the intake questionnaires. In addition, the child had to score above the cut-off on the Modified Checklist for Autism in Toddlers   or the SParticipants in the controlled trial group (n=50) were parents of a child with ASD between the ages of 19 and 73 months who had enrolled in the pilot (n=27) or full-scale efficacy trial  of ImPACT Online. To participate, the participant had to identify as the child’s mother, father, or step-parent, live within 3 hours of the research lab, and be proficient in English. Inclusion criteria for the child included being between the ages of 18 and 95 months at intake, meeting criteria for ASD on the Autism Diagnostic Observation Schedule-2nd Edition (ADOS-2) , and havInformation about the open trial was disseminated via flyers given to families by professionals at community organizations serving children with ASD, websites providing information about ASD, and an Internet search. Community organizations who expressed interest were given recruitment materials with a unique site code which participants entered at the time of program registration to track referrals. Recruitment materials provided a link to the ImPACT Online website. The website described the content of the program, system requirements, research requirements, and allowed visitors to view a brief video demonstration of the program. Participants had to indicate their consent to participate in research before registering. After registration, participants were asked to complete several short pre-treatment questionnaires and were then given access to the program. 6 months after registration, participants were sent an email asking them to complete the post-treatment questionnaires. Non-responders were sent a follow-up email one week, and two weeks later, until a total of three emails were sent. Participants received a US $25 gift certificate for the completion of the post-treatment questionnaires. Throughout their participation, participants in the open trial received no individual contact with research staff.Information about the pilot and subsequent full-scale efficacy trials was disseminated via community providers to families within 3 hours of the research lab. Interested parents were directed to contact the research lab to learn more about the specific study. Consent and intake assessments were conducted in person at the research lab and in the family’s home. All participants were provided a computer and high speed internet, if needed.After intake assessments, pilot study participants were randomly assigned to a self-directed (n=13) or therapist-assisted group (n=14). Participants in the full-scale study were randomly assigned to a self-directed (n=6), therapist-assisted (n=8), or informational control group (n=9). Participants in the self-directed groups for both studies received periodic individual phone and email contact from project staff regarding research-related tasks throughout their participation, but they received no support in learning the intervention. Participants in the therapist-assisted groups for both studies received access to the ImPACT Online website in addition to twice-weekly coaching via videoconferencing to help them learn the intervention. Participants in the informational control group received access to an informational website and monthly support calls. Participants completed post-treatment questionnaires and assessments after roughly 6 months, and again at a 3-month follow-up. Participants received a US $25 gift certificate for the completion of assessments at pre- and post-treatment, and follow-up.ImPACT Online is a secure, password-protected, interactive Web application. The content was adapted from Project ImPACT , a naturOne community organization, a university-based diagnostic center, tracked the number of referrals made to the program (recruitment flyers distributed during the diagnostic feedback session). The organization also tracked the age of the child in months, the child’s gender, and the family’s zip code. Zip codes were used to derive a median household income using US Census data for the referral group. This information was then compared with the same data provided by families who enrolled in the program using the referral site’s unique access code to calculate the potential reach of the program and the representativeness of the participants.Participants were asked to provide information on their gender, education level, employment status, marital status, and zip code. They were also asked to provide information on their child’s gender, age, diagnostic status, the number of hours per week, and the type of intervention their child received.Participants completed a brief, modified version of the Computer-Email-Web Fluency Scale  at pre-tProgram engagement was measured via ImPACT Online’s electronic tracking of user behavior. Four metrics of program engagement were calculated: (1) average number of logins to the site, (2) average number of minutes spent on the site across the intervention period, (3) percent of learning activities visited at least once across the 12 lessons (out of a possible 71), and (4) program completion defined by having visited 75% or more of the learning activities. We also examined the percent of participants completing each lesson to determine whether there was a drop-off in program engagement associated with a particular lesson. Completion was defined as having clicked on 75% or more of the learning activities for a lesson at least once.Participants completed the ImPACT Knowledge Quiz, a 20-item, multiple-choice quiz, that assesses comprehension of the key elements of ImPACT at intake and approximately 6 months later to measure changes in their intervention knowledge.. Questions are answered on a scale of 1 (“Never a problem”) to 5 (“Very often a problem”), with higher scores indicative of a greater number of perceived barriers. Items were modified to reflect potential barriers associated with the use of a self-directed, telehealth-based parent training intervention , resulting in the removal of 17 items assessing therapist- and clinic-related barriers, and the addition of 5 items assessing technology-related barriers. The modified scale contained 32 items and had a Cronbach alpha of .87. Participants were also asked to respond to 3 open-ended questions: (1) Please indicate any benefits of this program, (2) Please indicate any limitations of this program, and (3) Please provide any recommendations for improving this program.Participants in the open trial were asked to complete several measures to evaluate their experience with the program and barriers to program engagement 6 months after registering with the site. The Behavioral Intervention Rating Scale (BIRS) is a well-validated measure that asks individuals to endorse items that assess the acceptability of a treatment’s procedures and its perceived effectiveness on a 6-point scale, ranging from 1 (highly disagree) to 3  to 6 (highly agree) . The BIRThe data were examined for normality by inspecting the skewness coefficient. Number of logins and the amount of time spent on the site were both positively skewed; a square root transformation was used to normalize their distributions. Intervention knowledge at post-treatment was negatively skewed; an arcsine transformation was used to normalize intervention knowledge at pre and post-treatment. All other data were normally distributed.21 (N = 161) =.1, P=.78, child age in months , t34=−.03, P=.98, or median income , t35=1.49, P=.15).We first examined the reach of ImPACT Online for one referral site by comparing the number of parents who registered for ImPACT Online with the number of parents who were provided a referral from a professional at the time of diagnosis at that site (n=139). A total of 36 parents (25.8%) who were given information about ImPACT Online at the time of their child’s diagnosis registered with the site. Child gender, age, and median household incomes per year were compared for parents who registered (participant sample) and the referral sample. No significant differences were found between the two groups regarding gender distribution , χt tests revealed no significant group differences on any of these parent demographic variables.Next, we compared the demographics of families who enrolled in the open trial  with the controlled trial studies , regardless of whether they had completed the 6-month follow-up period or their group assignment in the lab-based trials. As shown in  t160=5.22, P<.001, likely due to the age restriction of the controlled trials. Children in the open trial were marginally more likely to be a racial or ethnic minority than the lab-based trials (OT: 38.4% (43/112); CT: 24.0% (12/50)), χ21, (n=162) =3.2, P=.07, which could reflect the general demographics of the recruitment area for the controlled trials.The majority of child participants in both groups were male (OT: 83.0% (93/112); CT: 76.0% (38/50)), and rates did not significantly differ between groups. The children’s mean chronological age was significantly higher in the open trial  than the controlled trial , t97=−1.95, P=.05.Participants in both groups reported that their children received a variety of different intervention services , with intensities ranging from 0 to 41 hours per week. However, children in the open trial  received marginally fewer hours per week of intervention than children in the controlled trials , Next, we examined program engagement metrics for the subset of participants in the open trial who had completed the 6-month follow-up period (n=94). A number of participants who enrolled in the open trial did not access the program after completing the pre-treatment assessments. Thus, we only included data from participants who accessed the first lesson . In our previous work, therapist assistance was shown to enhance parent engagement in the program . Thus, iF3, 81=21.14, P<.001; Wilk’s Λ=.53, ƞ=.47. As observed in 21 (N=85)=40.3, P<.001.We examined group differences on the first three metrics of program engagement using MANOVA . There was a significant effect of trial type on program engagement, To better understand the rate of attrition, we examined the percent of participants who completed each lesson for the two groups. As observed in t=2.43, P=.02, and explained additional variance in post-treatment intervention knowledge . This finding suggests that regardless of the trial type, participants who completed more of the program made greater improvements in their intervention knowledge from pre- to post-treatment.We examined the degree to which program engagement was predictive of gains in parent intervention knowledge. We included those participants in the open trial  and the self-directed groups of controlled trials  who had completed the post-treatment questionnaire. For this analysis, we used a hierarchical linear regression, with parents’ intervention knowledge at the 6-month follow-up as the dependent variable. Parents’ pre-treatment intervention knowledge and trial type were entered in the first step. Program engagement, defined as percent of learning activities completed, was entered in the second step. After controlling for pre-treatment intervention knowledge and trial type, program engagement was a significant predictor of post-treatment intervention knowledge, beta=.41, Finally, we examined the program evaluation measures for the participants in the open trial (n=26). Participants reported the program as highly acceptability on the BIRS  and the website as highly usable . Parents also reported low levels of perceived barriers on the modified BTPS . To understand the most common perceived barriers to using this program better, we examined the means for individual items on the modified BTPS. The three barrier items with the highest means (means ≥2.5) were: (1) “I did not have the time to practice (complete the homework)” ; (2) “During the course of treatment, I experienced a lot of stress” ; and (3) “Crises at home made it hard for me to complete the program” .The open-ended responses were analyzed by compiling responses and identifying emergent themes using inductive content analysis. Two authors worked independently to develop codes based on the written responses. They then met to discuss initial codes and develop consensus regarding final codes. Any conflicts were discussed until consensus was reached. The most frequent themes identified in response to the program’s benefits, limitations, and recommendations are presented in Program BenefitsAccessibility of the programEase of learning the interventionAcceptability of intervention strategiesImprovement in child social communication skillsProgram LimitationsNeed for therapist supportLack of online community supportTime requirementsStress in the homeTechnology barriersProgram RecommendationsTeleconference support from coachIncrease online community supportSimplification of training componentsMake available on other platformsIn this study, we conducted an open trial of the self-directed format of ImPACT Online to understand its dissemination and implementation potential better. Our reach data indicate that only a quarter of parents who were provided information about the program at the time of their child’s diagnosis registered with the site. This finding is somewhat sobering given that parents in our pilot study reported that they would have liked to have received information about the program at the time of their child’s initial ASD diagnosis . The facOur reach data were obtained from a specialty diagnostic clinic that provided a referral to the program at the time of diagnosis. It is unclear what the reach of this program would be in other communities or means of dissemination, such as advertisements, web-links, personal invitation via mail or email, or personal recommendation provided by an intervention provider. Different methods of dissemination may be expected to lead to different levels of enrollment as well as ongoing engagement with the program. Additional research that can examine differences in referral methods and the optimal times to refer parents to such programs would be helpful.Although the data we were able to collect about families before they enrolled in the open trial were very limited, what we did collect suggested that those families who enrolled in the program were not significantly different from the referral sample in terms of median household income, child gender, or age. Although limited by sample size, this finding provides some indication that the families who enrolled in the open trial were fairly representative of the referral group. In addition, our demographic information suggests that, for the most part, participants who enrolled in our controlled trials were very similar to families who enrolled in the open trial. Although these data are, again, limited due to sample size constraints, they provide some confidence that the data being generated from our ongoing efficacy study may well generalize to community users. At the same time, there were few families with very low socioeconomic status in any of our samples, and thus, participation was not representative of the full range of families who could potentially benefit from this type of intervention. Therefore, future research should focus on increasing enrollment of parents from low socioeconomic status backgrounds into both open and controlled trials of telehealth-based, parent-mediated intervention.Our program engagement data suggested much lower rates of engagement among our open trial participants than the participants in our controlled trials. This finding is not surprising given the previous research on telehealth-based interventions for other conditions. Participants in our controlled trials received a significant amount of personal contact with the research team throughout their participation, which may have affected their motivation to engage with the program. Although program engagement was much lower among participants in the open trial than the controlled trial, it was still higher than many open trials of similar interventions -37. ThisIt has been proposed that program completion may not be necessary to achieve significant improvements, in part because some individuals who discontinue eHealth interventions do so because they improve . InspectOur program evaluation data for the open trial participants suggested high levels of the treatment acceptability and website usability and low levels of perceived barriers. Our qualitative data complemented these findings, suggesting that parents identified a number of benefits of the program, including the accessibility of the program, and the ease of learning the intervention, the acceptability of the intervention strategies, and improvement in their child’s social communication skills. These themes have also been identified among participants in our controlled trial .The most consistently reported barriers on the modified BTPS and open-ended questions were related to competing stressors at home and difficulty finding time to complete the program. These barriers might be expected to adversely impact parent participation in all forms child treatment, not just self-directed, telehealth-based parent-mediated intervention . Our quaThe literature suggests a number of program design factors that may impact engagement in self-directed telehealth interventions, such as ImPACT Online . First, Second, the Pew Research Center states that people are increasingly turning to their mobile phones to access the Internet . Thus, mFinally, online communities may help improve peoples’ use of health content and interventions . ImPACT Future research that can evaluate which strategies are most likely to increase parent engagement in ImPACT Online and similar interventions is needed. In addition, as we did not collect data on other aspects of parent learning such as procedural fidelity, parent well-being, or child gains, future research should investigate how this program impacts important parent and child outcomes in real world settings.


Group-based early parenting interventions delivered through community-based services may be a potentially effective means of promoting infant and family health and wellbeing. Process evaluations of these complex interventions provide vital information on how they work, as well as the conditions which shape and influence outcomes. This information is critical to decision makers and service providers who wish to embed prevention and early interventions in usual care settings. In this paper, a process evaluation protocol for an early years parenting intervention, the Parent and Infant (PIN) program, is described. This program combines a range of developmentally-appropriate supports, delivered in a single intervention process, for parents and infants (0–2 years) and aimed at enhancing parental competence, strengthening parent-infant relationships and improving infant wellbeing and adjustment.The process evaluation is embedded within a controlled trial and accompanying cost-effectiveness evaluation. Building from extant frameworks and evaluation methods, this paper presents a systematic approach to the process evaluation of the PIN program and its underlying change principles, the implementation of the program, the context of implementation and the change mechanisms which influence and shape parent and infant outcomes. We will use a multi-method strategy, including semi-structured interviews and group discussions with key stakeholders, documentary analysis and survey methodology.The integration of innovations into existing early years systems and services is a challenging multifaceted undertaking. This process evaluation will make an important contribution to knowledge about the implementation of such programs, while also providing an example of how theory-based research can be embedded within the evaluation of community-based interventions. We discuss the strengths of the research, such as the adoption of a collaborative approach to data collection, while we also identify potential challenges, including capturing and assessing complex aspects of the intervention.ISRCTN17488830 (Date of registration: 27/11/15). This trial was retrospectively registered.The online version of this article (doi:10.1186/s12913-016-1737-3) contains supplementary material, which is available to authorized users. The nature of the caregiving environment experienced at an early age plays a pivotal role in child development. Several studies and meta-analyses have demonstrated that early childhood interventions implemented between pre-birth and 3 years can help to improve parent-infant relationships and parenting skills –3. ReseaRecent significant advances in the delivery and testing of early parenting programs, as well as the accumulation of results from controlled trials, provide an important evidence base for ‘what works’ for parents and children . DespiteThere is increasing recognition of the importance of effectively implementing prevention and early intervention programs in order to ensure positive outcomes , 14. Indwww.mhsru.com). The research program is being conducted over a 5 year period (2014–2019) [The dearth of process-oriented research means that decision makers and service providers are often unclear about how and when such programs may be effectively embedded within community-based early years services , 26. Thi14–2019) . This gr14–2019) .Develop a program theory: Document, in detail, the design and development of the PIN program and outline its change principles and underlying assumptions.Assess implementation: Outline the key resources involved in program implementation and the extent to which the program is implemented as intended (i.e. fidelity to the program model/change principles); examine patterns of participation within the program, including the role of program developers and implementers, as well as program reach, recruitment, and participants’ patterns of engagement and responses to the program; and identify implementation barriers/facilitators.Explore the context of program delivery: Examine the conditions in which the PIN program is delivered including the individual, interpersonal and organisational capacities which support implementation; and explore the circumstances or contextual factors which influence the experiences of key stakeholders.Identify mechanisms of impact: Identify patterns of interaction between the program, the stakeholders involved, and the context in which the program is delivered and explore the extent to which these shape, either positively or negatively, the implementation and impact of the program; and identify lessons for the development and implementation of other similar complex prevention and intervention programs.The overarching aims of this process evaluation are to gain an understanding of the active ingredients of the PIN program and to systematically evaluate the processes and conditions which influence program implementation and effectiveness. More specifically, the process evaluation will attempt to ‘unpack’ the program components in order to identify and describe the causal assumptions underpinning the program and, in turn, assess how those change principles are substantiated through implementation. The conditions/factors which influence or shape program implementation and responses to the intervention will also be examined. In this way, we will examine how the program works (or does not work) and whether there are facilitators and/or barriers to program implementation and effectiveness. The specific objectives  . The benThe analysis of PIN program implementation (objective 2) will be guided by the work of Baronowski and Stables  who deveThe service delivery context which will be conceptualised as incorporating the capacities of individuals , organisational infrastructures  and interpersonal relationships .The broader contextual factors which are external to the intervention and which may shape and/or influence participants’ responses to the intervention .There is increasing recognition that programs can influence different people in different ways, while the success of implementation strategies and/or processes is frequently mediated by conditional or contextual influences . TherefoWe will explore, in turn, the interplay between the PIN program and its components, persons and conditions in order to gain insights into the processes of change arising from the intervention (objective 4). Thus, we will draw on a realist evaluation perspective  to invesGiven the complexity of social interventions such as the PIN program, the program theory will be used to identify priority avenues for investigation in relation to the implementation and effectiveness of the intervention . We willThe PIN program combines a range of developmentally-appropriate parent and infant supports which are delivered in a single intervention process from birth to 2 years of age  program in Ireland . The ABCA detailed process evaluation is being conducted in conjunction with a large-scale, longitudinal controlled before-and-after impact evaluation to assess the effectiveness of the program. Parents from within the sites where the program is delivered are recruited to the PIN program by Public Health Nurses and/or local, community-based service providers. Parents who are recruited to the program will subsequently be invited to participate in the research. A comparison group of parents who receive services as usual (and no PIN intervention) will be recruited from neighbouring areas with a similar profile to the intervention areas. Usual services in the non-intervention area for parent-infant dyads involve: one home visit from a PHN in the first 6 weeks after birth, regular developmental check-ups with a GP/PHN and vaccinations.Prospective participants will be informed of the research verbally and by means of a brief brochure describing the research. Potential participants will then be asked to provide their written consent to be considered for inclusion in the research and for their details to be passed to the research team. If this consent is provided, names and telephone numbers are confidentially passed to the research team. Participants will then be contacted by the research team and furnished with a detailed information sheet. All participants must be aged 16 years or older and will provide written informed consent. A power calculation conducted on the basis of comparing the mean score of an intervention group on the Parenting Sense of Competence Scale (PSOC)  to that Baseline assessments will be conducted with parents when the infant is approximately 6 to 14 weeks old. Subsequent follow-up assessments will be carried out when the infant is approximately 8, 16 and 24 months of age. The impact of the program, when compared to services as usual, will be investigated by assessing parent competencies and wellbeing, parent-infant relationships, child development and socioemotional adjustment. The process evaluation will be vital to interpreting the outcomes of the PIN program, while it also forms part of a wider goal to contribute to our understanding and knowledge of the effective implementation of complex early parenting intervention programs, including the relationships between program components, implementation processes, contextual factors and program outcomes. The process evaluation is being conducted by a multi-disciplinary research team independent of program development, implementation and delivery.Study participants will include program developers and implementers, as well as parents who take part in the PIN program. This process evaluation will be based on both qualitative and quantitative methods. Data collection will be conducted in two focused phases. During the first  phase, data collection will focus on explicating the theory underlying the intervention, identifying the causal assumptions inherent in the program and outlining the activities, resources and factors which are assumed to be necessary to achieving program outcomes.The second phase of data collection will expand on early findings and focus on exploring the processes involved in program implementation, patterns of engagement with the program, as well as the context in which the program is situated. Both quantitative and qualitative data will be gathered to explore program delivery processes, uptake and coverage, responses to the intervention, barriers to effective implementation of the program (e.g. program reach and participant engagement) and competing programs. As the PIN program is already being implemented, quantitative data relevant to program implementation  will also be collected during phase one of data collection. An in-depth examination of program implementation and contextual factors will inform a critique of fidelity to the PIN program theory, while also highlighting adaptation/innovation and enabling the interpretation of findings from the impact evaluation. The data gathered throughout the process evaluation will be synthesised and analysed in order to identify the mechanisms through which the intervention activities produce intended or unintended effects.A wide range of data sources will be used to develop an in-depth understanding of the PIN program, the key activities, processes, inputs and outputs involved in, and conditions associated with, program delivery and implementation.Phase 1 data sourcesLiaison with PIN program developers and implementers: The evaluation team and program developers and implementers are in regular communication. This will provide important insights into program logic, the choices made in relation to program content, preparation and groundwork for delivery as well as the planning and management of implementation.Documentation: A documentary analysis will be carried out which will involve the review and critical analysis of a wide range of relevant documentation including: meeting minutes; organisational reports and publications; online material; brochures; program proposals and descriptions; program manuals and written materials; official policy documents and demographic data; publications, reports, and journal articles. This data will contribute to refining ideas and identifying the conceptual foundations of the PIN program.Interviews: Program developers and implementers will be interviewed to explore the developmental origins of the PIN program, factors which influenced intervention design, development, and content, as well as related motivations, attitudes, perceptions and beliefs.Phase 2 data sourcesLiaison with PIN implementers: Regular contact/meetings between the PIN program Project Coordinators (in both Site 1 and 2) and the evaluation team will be held to provide updates on: the development and implementation of program components; choices made in relation to program content and implementation; participant recruitment; the timing, delivery and implementation of intervention components; implementation and operational activities; as well as any planned and/or unplanned or forced changes to the program components and its delivery. Regular contact will also enable the evaluation team to monitor how operational and implementation activities evolve over time.Records and documentation: Records of recruitment procedures will be taken, including the number of prospective participants invited to participate in the program. Recruitment protocols, implementation manuals and other relevant documents (e.g. meeting minutes) will also be included in a documentary analysis. Demographic data, as well as routine documentation maintained by participating organisations (e.g. PHNs) including area birth rates, will be used to critique program reach.Impact evaluation data: Participant demographic data collected through the impact evaluation baseline assessments will be used to examine the characteristics of parents who engage with, and continue to participate in, the program. This data will be used to assess program reach and the maintenance of participant engagement. All parents who take part in the trial will also be asked, by means of a follow-up questionnaire administered by the evaluation team, to report uptake of services and supports which are external to the PIN intervention. In addition, parents in the control group will asked if they have accessed any of the treatment components (e.g. Baby Massage). This will enable the research team to examine if, and to what extent, contamination is occurring, thereby facilitating the accurate interpretation of program outcomes.Attendance checklists: Parent participants attendance for each program component will be routinely recorded by program facilitators. The number of sessions per component which individual parents attend, as well as the attendance of partners (if applicable), will also be recorded. Reasons for parental absence/non-attendance will be documented if available.Parent participant feedback forms: Parent feedback forms will be administered following the completion of each program component. These questionnaires will measure participant satisfaction as well as the perceived utility of the content of each program component, and facilitator effectiveness ; as well as highlighting any deviations from program content/protocols  and organisational capacity building processes (e.g. availability of training and/or other supports for program implementers)  Parent participants will be interviewed to explore issues pertaining to parenthood, including the experience of becoming a parent, parental expectations and the experiences and challenges/difficulties of parenting during infancy. These interviews will also focus on: parents’ experiences of taking part in the program; the extent to which they use the parenting skills, strategies, materials and information specified in the program; whether they continue to use such skills, strategies, material and information over time; barriers to program engagement/attendance; and factors which influence parenting experiences. A small number of partners of participating parents may also be invited to take part in qualitative interviews.Interview/group discussion procedure and participant sampling. All interviews and group discussions will be audio-recorded with consent and guided using a schedule of open-ended questions. Interview/group discussion questions will be altered to reflect stakeholders’ experiences in relation the PIN and stages of program implementation (e.g. to explore emergent issues in implementation and/or participation in the PIN program). A purposive sampling method will be used to identify and recruit participants. Selection and recruitment will be designed to include as wide and diverse a range of perspectives as possible and to access participants’ expertise in relation to the key research questions. Key inclusion/selection criteria include the participants’ role within the development and/or delivery of the PIN program and their ability to provide insight into the key issues influencing, and affected by, program development and implementation. Parent participants will be selected from the overarching intervention group recruited to take part in the PIN program and the effectiveness evaluation (n = 100 approximately). Key demographic variables , program delivery cycle and level of program engagement (e.g. no. of sessions attended) will be used to recruit parents to the process evaluation. Care will be taken to ensure diversity and balance throughout the sampling process.It is anticipated that approximately 40 key stakeholders will be invited to take part in interviews/group discussions. A responsive approach to sampling will be adopted; thus, as the research and data collection process progresses, potential participants will be identified and recruited on the basis of emergent findings. During the later stages of data collection, a small number of key informants will be re-interviewed or invited to take part in groups discussions in order to assess any potential changes over time in program implementation and delivery context, as well participants’ experiences, attitudes and beliefs.All qualitative data will be retained as written electronic files including document summaries and interview and group discussion transcripts. Interviews and group discussions will be recorded (with consent) and transcribed verbatim. Audio-files will be destroyed after transcription and all qualitative data will be stored securely on a password protected computer. All transcripts will be anonymised and any potentially identifiable data removed.A thematic analysis will be used to systematically analyse all qualitative data . This anQuantitative data from implementer and participant feedback forms, attendance checklists and questionnaires will be entered into a password protected database and will be analysed in SPSS using appropriate descriptive and inferential statistics. Analysis of the stakeholder survey will focus on variability across groups, while the extent to which the intervention is delivered as intended will be examined by exploring the proportion of the essential material which was reported as delivered. Variability in the extent to which the program is delivered as intended across facilitators/parent groups and change over time will also be examined. In addition, the proportion of parent participants who report high levels of satisfaction with, and high perceived utility of, the PIN program and its sub-components will be reported. We will also explore whether there are any significant differences in satisfaction and perceived utility across parent participant sub-groups (e.g. primiparous and multiparous mothers). Program reach will be assessed by examining the proportion of the mothers who have given birth in the treatment areas and who are recruited to, and engage with, the program. Dosage will be analysed by determining the average number of program sessions attended by parent participants. Systematic differences between those who attend a high percentage of sessions and those who fail to engage/attend a low number of sessions will also be assessed.The blending of findings from different and multiple data sources will be an important step in refining the interpretations of program outcomes, understanding the context of program delivery and, in particular, identifying mechanisms of impact. For example, narrative accounts of implementation (e.g. transcribed interviews) will be triangulated with findings from the stakeholder survey and implementer/participant feedback forms, as well as outcome data from the impact evaluation. At this stage of analysis, data will be interrogated in order to identify patterns of interactions between the PIN program theory and its implementation, participant responses and contextual factors. Thus, the data will be appraised in order to understand how the PIN program works and, in turn, to identify key mechanisms which are critical to program success or, conversely, where program and/or implementation failures are likely to occur.This process evaluation will be carried out by a small team of experienced researchers from different backgrounds with considerable experience both of mixed methods and of undertaking large-scale community-based evaluations. A number of steps will be undertaken to ensure a rigorous approach to data collection and analysis including: (i) a purposive and responsive sampling method to ensure a broad and diverse participant sample and, in turn, good conceptual generalisability; (ii) a systematic approach to data collection and analysis and drawing on a rich range of data sources including quantitative and qualitative data; (iii) triangulation of findings across multiple sources of data; (iv) respondent validation via reiterative sampling and transcript reviews; (v) reflexively assessing the role and input of the researcher(s) with respect to data generation and data analysis; and (vi) ‘sensitivity to context’, including reference to appropriate literature and theory, as well recognising and examining differing perspectives and the context in which data and findings are generated . Thus, pIn this paper we provide a detailed protocol for a process evaluation nested within a controlled trial of an early parenting intervention program aimed at improving parental competencies and infant wellbeing in the earliest years of life. It is increasingly recognised that implementation is vital to the effectiveness of prevention and early intervention programs . New proThis evaluation will adopt a comprehensive and rigorous, approach to the evaluation of the structures, processes and causal mechanisms inherent in the implementation of the PIN program. Nuanced information regarding the attitudes, characteristics and skills of program implementers, as well as interpersonal interactions, resources and circumstances around program implementation, will be collected using a broad range of quantitative and qualitative research methods.This research will also be conducted by an experienced, multidisciplinary team of researchers who are working in close collaboration with a range of community-based stakeholders involved in program delivery and implementation. Positive working relationships between the evaluation team and program developers and implementers have already been developed and are being closely monitored and maintained. This will be important in supporting the process evaluation in a number of ways. For example, regular positive communication between the research team and stakeholders will ensure that the evaluators are notified and informed about any planned phases of implementation. Challenges and changes to program content and delivery can also be highlighted. In addition, PIN program implementers will assist with data collection (e.g. maintaining and providing participant feedback forms) and are also committed to monitoring fidelity and implementation processes. While this will help to reduce the costs of data collection and participant burden, facilitator self-assessment of fidelity and distribution of participant evaluation forms may bias implementation and/or result in Hawthorne effects. However, similar procedures for implementation fidelity monitoring have been reported elsewhere , 58. FurPotential challenges must also be noted. Firstly, the evaluation team will not communicate emerging findings from the process evaluation to key stakeholders in order to avoid any interference in the implementation process. However, the PIN program theory will be developed in collaboration with key stakeholders, whilst an interim evaluation report will also be made available prior to the completion of this study. There may also be instances where it is ethically imperative to communicate findings of the process evaluation to program developers/implementers (e.g. evidence of harm). It is possible that such interactions between the evaluation team and program developers/implementers may influence the development of the program and/or implementation activities. Secondly, the team of researchers with responsibility for conducting this process evaluation are also involved in conducting the outcome evaluation and cost-effectiveness analysis. This integration will be important in facilitating data sharing and in minimising participant burden; however, data collectors cannot be blind to program allocation and, therefore, some potential for bias in the interpretation of program functioning and outcomes may arise. For this reason, a reflexive approach to data collection and analysis will be adopted in order to minimise any bias and improve the reliability and validity of the findings. Analyses of program effectiveness will be conducted by the research team’s Data Manager who is blind to group allocation and not involved in any way in data collection.Finally, the complex nature of the PIN program presents challenges. For example, the program consists of multiple interrelated and interdependent components, as well as multiple stakeholders. Some elements of the program are manualised (e.g. IY programs), while other components are not. Additionally, there are differences in program content and implementation processes across sites, while there is also likely to be adaptation and learning by those implementing and those receiving the intervention as delivery proceeds , 60. TheThere remain significant barriers to ensuring that vulnerable children and families receive high-quality early intervention and prevention services and supports . It is i


Substance use and misuse often first emerge during adolescence. Generic life skills training that is typically conducted within the school curriculum is effective at preventing the onset and escalation of substance use among adolescents. However, the dissemination of such programs is impeded by their large resource requirements in terms of personnel, money, and time. Life skills training provided via mobile phones might be a more economic and scalable approach, which additionally matches the lifestyle and communication habits of adolescents.The aim of this study was to test the acceptance and initial effectiveness of an individually tailored mobile phone–based life skills training program in vocational school students.ready4life, is based on social cognitive theory and addresses self-management skills, social skills, and substance use resistance skills. Program participants received up to 3 weekly text messages  over 6 months. Active program engagement was stimulated by interactive features such as quiz questions, message- and picture-contests, and integration of a friendly competition with prizes in which program users collected credits with each interaction. Generalized estimating equation (GEE) analyses were used to investigate for changes between baseline and 6-month follow-up in the following outcomes: perceived stress, self-management skills, social skills, at-risk alcohol use, tobacco smoking, and cannabis use.The fully automated program, named P=.03) and increases in several life skills addressed between baseline and the follow-up assessment. The proportion of adolescents with at-risk alcohol use declined from 20.2% at baseline to 15.5% at follow-up , whereas no significant changes were obtained for tobacco  or cannabis use .The program was tested in 118 school classes at 13 vocational schools in Switzerland. A total of 1067 students who owned a mobile phone and were not regular cigarette smokers were invited to participate in the life skills program. Of these, 877  participated in the program and the associated study. A total of 43 students  withdrew their program participation during the intervention period. The mean number of interactive program activities that participants engaged in was 15.5 (SD 13.3) out of a total of 39 possible activities. Follow-up assessments were completed by 436 of the 877 (49.7%) participants. GEE analyses revealed decreased perceived stress (odds ratio, OR=0.93; 95% CI 0.87-0.99; These results reveal high-level acceptance and promising effectiveness of this interventional approach, which could be easily and economically implemented. A reasonable next step would be to test the efficacy of this program within a controlled trial. Several biological, psychological, and social transitions that occur during adolescence are essential for a young person’s later-life trajectory ,2. TheseThe age of onset of substance use is similar across high-income countries, with increasing levels and frequency of use beginning in mid-adolescence, peaking during early adulthood . AccordiAs most young people do not fulfill criteria for problematic or disordered use, prevention programs and early intervention should be the focus, rather than substance-related treatment measures. A recent systematic review of studies assessing the effectiveness of prevention, early intervention, and harm reduction in young people for tobacco, alcohol, and illicit drugs demonstrated the effectiveness of taxation, public consumption bans, advertising restrictions, and minimum legal age, as well as the potential effectiveness of preventative interventions that deliver life skills training in educational settings . SchoolsA Cochrane review on school-based programs for the prevention of tobacco smoking  concludeAccording to the WHO, life skills are “abilities for adaptive and positive behavior that enable individuals to deal effectively with the demands and challenges of everyday life” . The majGeneric life skills programs to prevent substance use, such as the IPSY  program developed in Germany  or the AAlthough these life skills training programs were effective at preventing the onset of specific substances ,13 or atElectronically delivered interventions  have the potential to overcome the aforementioned obstacles that hinder successful program implementation and dissemination of life skills training in schools at a larger scale. Electronically delivered interventions have a wide reach at a low cost and offer the opportunity to automatically deliver individually tailored contents that can be accessed at any time and in any place . FurtherBeyond traditional personal computers, a promising means of delivering prevention programs is to do so remotely through the use of mobile technologies. In Switzerland, as in most other developed countries, almost all (98%) adolescents between the ages of 12 and 19 years own a mobile phone, and 97% of these phones are smartphones . Most adSeveral studies have underlined the potential and effectiveness of substance-specific mobile phone–based programs for early interventions in adolescents already consuming specific substances such as tobacco or alcohol -22. HoweConsequently, the objectives of this study were (1) to test the acceptance, use, and evaluation of a mobile phone–based life skills program among vocational school students and (2) to explore its potential effectiveness.In most European countries, vocational schools are postsecondary public schools that are analogous to American community colleges. They are a part of the dual educational system that combines apprenticeships in a business context and vocational training in a school context. Vocational schools provide general education and specific skills for each particular profession.On the basis of data from the Swiss Federal Statistical Office, approximately half of all Swiss adolescents aged 16 to 19 years currently attend vocational schools , with thA longitudinal pre-post study design with assessments at baseline and after program completion (month 6) was used to test the initial effectiveness of the program. Prevention specialists from branches of the Swiss Lung Association , with particular training in the study and program to be delivered, arranged sessions lasting 30 min in participating vocational school classes during regular school lessons reserved for health education. Within this session, the students were informed about and invited to participate in a study testing innovative channels for the provision of health-related information and life skills. The students were informed by the prevention specialists about the study’s aims and assessments, reimbursement, and data protection. Students were also informed that they could withdraw from program participation at any time, simply by sending a short service message (SMS) expressing their request to stop the program.The mobile phone–based program and its association with a friendly competition with prizes were described in detail by the prevention specialists. To ensure sufficient participation and, thus, representativeness of the sample , studentOn the basis of previous results on the efficacy of texting-based programs for smoking cessation ,26, vocaAfter they had given their informed consent, study participants completed a baseline assessment directly on their mobile phone or on the tablet computer that they had been provided with. They received additional questions that were necessary to tailor their intervention’s content. Subsequently, participants received individually tailored Web-based feedback directly on their mobile phone. Over the subsequent 6 months, they received individually tailored life skills training provided via mobile phone texting. All subjects were invited to complete a Web-based follow-up assessment after program completion 6 months after their enrollment in the study. For this, they received a text message (SMS) with a Web link to the Web-based assessment. Up to two text message–based reminders were sent to those who failed to complete the follow-up assessment upon initial request.The study protocol was approved by the Ethics Committee in the Faculty of Philosophy at the University of Zurich, Switzerland  and the trial conducted in compliance with the Declaration of Helsinki.ready4life are based on social cognitive theory [The intervention elements of the program called e theory ,29. Thise theory , though ready4life rely on proven and widely disseminated life skills programs such as IPSY [The contents of  as IPSY , ALERT [ as IPSY , and Lif as IPSY . The proThe intervention program was developed using the MobileCoach system. Technical details of the system are described elsewhere ,31. The Individually tailored Web-based feedback was given immediately after subjects completed the Web-based baseline assessment during school classes using tablet computers or mobile phones. This feedback comprised five screens, which included textual and graphical feedback on the following: (1) stress in general; (2) the individual level of stress in various domains; (3) the individual level of stress compared with an age- and gender-specific reference group, based on the Perceived Stress Scale (PSS)  and on dFor a period of 6 months, program participants received between two and four individualized text messages per week on their mobile phone. These messages were generated and sent by the fully automated MobileCoach system. Within the first 9 weeks, the messages focused on self-management skills; for example, coping with stress, emotional self-regulation, or management of feelings of anger and frustration. In the weeks 10 to 15, the messages focused on social skills, for example, making requests, refusing unreasonable requests, and meeting new people. In weeks 16 to 20, the text messages focused on substance use resistance skills, for example, recognizing and resisting media influences, social norms of substance use, or the associations of self-management skills and interpersonal competences with substance use. Boosters for each of the components were provided in weeks 22 to 24. The program concluded with information about a prize draw and an invitation to participate in the follow-up assessment. The messages were tailored according to the individual data from the baseline assessment and on-text messaging assessments during program runtime, for example, on substance use or the individual’s emotional state. Sample messages from different intervention components are displayed in To exploit the full potential of current mobile phones, several interactive features—such as quiz questions, tasks to create individually tailored if-then behavior plans based on implementation intentions, and message contests—were implemented within the program. Within picture and message contests, participants were invited to create and upload text messages or photos on specific topics, for example, on individually preferred strategies to cope with stress or on relaxation possibilities. The messages or pictures provided by other participants could be rated anonymously on a separate responsive website by all participants, and the top three postings were presented anonymously to all other participants after 48 hours on a website, which was only accessible for program participants. All messages and photos created by the participants were checked by a junior scientist with respect to the appropriateness of their content. Inappropriate content was excluded and not presented to the other participants.Due to the wide dissemination of mobile phones in adolescents , severalTo stimulate active program engagement, program use was associated with a friendly competition that allowed program users to collect credits for each interaction . The more credits participants collected, the higher were their chances of winning one of several attractive prizes that were part of a prize draw after program completion. Participants could retrieve their number of credits compared with the number of credits of other program participants of their group (similar starting date and Canton) at any time from an individual profile page .Before the study, a prototype of this program was tested and evaluated in five focus groups. Within these focus groups, individuals in the age range of 16 to 20 years, drawn from local vocational schools were asked to evaluate program flow, the layout and content of the Web-based assessment and feedback, and the content of text messages. Optimizations that resulted from these focus groups were integrated into the final version of the program.The baseline survey included questions about the following demographic variables: gender, age, and migrant background. For the last of these, we asked about the country of birth of both parents of each vocational school student to identify potential migrant backgrounds. On the basis of this information, persons were assigned to one of the following categories: (1) persons with neither parent born outside Switzerland—no migrant background and (2) persons with one or both parents born outside Switzerland—migrant background.Life skills were assessed at baseline and 6-month follow-up. The life skills assessed were related to the contents of the program and focused on (1) stress, (2) self-management skills, and (3) social skills.A four-item version  of the PSelf-management and coping behavior within vocational training were assessed using one item derived from each of the five subscales of the Questionnaire for the Measurement of Stress and Coping in Children and Adolescents (SSKJ 3-8) . The iteSocial skills were assessed using a scale with seven items derived from the Assertion Inventory . These iIndicators of substance use were assessed at baseline and follow-up and included (1) at-risk alcohol use, (2) tobacco smoking, and (3) cannabis use.At-risk alcohol use was assessed through the consumption items of the Alcohol Use Disorder Identification Test (AUDIT), the AUDIT-C . The AUDTobacco smoking was assessed by the yes or no question: “have you taken at least one puff of a cigarette within the past 30 days?”Cannabis use was assessed with the item “Within the last six months, how often did you use cannabis or marijuana?” with the response options (1) “never,” (2) “1-5 times,” (3) “6-20 times,” and (4) “more often than 20 times.” To estimate the prevalence of cannabis use within the last 6 months, we collapsed response options 2, 3, and 4 into a single category: cannabis use.To obtain the number of program participants who unsubscribed from the program within the program runtime of 6 months, we analyzed the log files of the MobileCoach system in which all incoming and outgoing text messages were recorded. Using these log files, we also assessed the mean number of replies to the 12 text message assessments during the program. At follow-up, we assessed another aspect of SMS usage by asking the participants whether they usually (1) read through the text messages thoroughly, (2) took only a short look at them, or (3) did not read the text messages.Using a yes or no question, we evaluated whether the times when participants received the text messages were deemed to be appropriate. Furthermore, we assessed whether the number of received text messages was felt to be appropriate, or whether the participants would have preferred fewer or more messages. Finally, program participants were asked to rate the program and different program elements using the response categories “very good,” “good,” “less than good,” “bad,” and “don’t know.”To explore the intervention’s effectiveness, the pre-post changes between baseline and 6-months follow-up of the following variables were investigated: (1) perceived stress , (2) sel2analysis for categorical variables and nonpaired student’s t tests for continuous variables were applied. For the attrition analysis (program participants lost to follow-up), we used χ2analysis for categorical variables and t tests for continuous variables. Baseline equivalence and lack of attrition bias were assumed for tests with P>.10.To test for baseline differences between study participants and nonparticipants, Pearson χWe used generalized estimating equation (GEE) analyses to investigate the longitudinal course of the outcome criteria over the study period of 6 months. GEE is a repeated-measures regression model that takes into account the correlation of repeated measures within each subject . It is aWe used logistic GEE models for binary outcomes and linear GEE models for continuous variable outcomes. To control for attrition bias, we additionally added the respective baseline variables and variables on program use as covariates to the GEE models. Each GEE model included (1) the examined time variable (baseline vs follow-up assessment) as a predictor, (2) covariates to account for selective attrition, and (3) some outcome variable as the dependent variable.Given the clustered nature of the data (students within school classes and intraclass correlation for the considered outcomes ranged from .02-.06), we computed robust variance estimators for all GEE analyses. An alpha level of .05 (two-tailed) was chosen for all statistical tests conducted in the study. All analyses were performed using the Stata software package, version 12 (StataCorp).ready4life, 877  agreed to participate. Nonparticipants were subjects who met enrollment criteria but did not agree to participate in the study.Participants’ progression through the study is depicted in gender and migrant background. A greater percentage of study participants than nonparticipants were female  and had no migrant background .21=6.7, P<.01), by participants without a migrant background , by participants with higher values on the item on social support seeking , and by participants with a higher number of program activities during the program period . To account for this attrition bias, these variables were entered as covariates within the GEE models that compared changes in outcomes between baseline and 6-month follow-up.Follow-up assessments were completed by 436 of the 877 (49.7%) study participants. Concerning attrition bias, the analysis revealed that follow-up assessments were completed more likely by female than male participants  of the initial 877 program participants unsubscribed from the program, resulting in a total of 834  participants who completed the entire program.A total of 39 activities  were prompted over the 6-month program. The mean number of activities carried out by participants was 15.5 (SD 13.3). Of the 877 participants, 134 (15.3%) participated in no activities, 223 (25.4%) carried out 1 to 7 activities, 102 (11.6%) engaged in 8 to 14 activities, 82 (9.4%) in 15 to 21 activities, 123 (14.0%) in 22 to 28 activities, 156 (17.8%) in 29 to 35 activities, and 57 (6.5%) in 36 to 39 activities.Of the 387 subjects with valid follow-up data, 323 (83.4%) indicated that they “read the SMS messages thoroughly,” 61 persons (15.8%) reported that they “took a short look at the feedback messages,” and only 3 persons (0.8%) chose the predefined response category “I did not read the feedback messages.”The duration of the program was rated as appropriate by 334  program participants with valid follow-up data. The number of received SMS messages was rated as appropriate by 84.9% (328/386); 6.7% (26/386) would have preferred more, and 8.3% (32/386) would have preferred fewer SMS messages. Almost all participants reported that the text messages were comprehensible . Participants were also asked whether the text messages were helpful, and 296 out of 384 (77.1%) agreed with this. Three out of 4 participants  indicated that they perceived the text messages as individually tailored to them.P=.03). Meanwhile, statistically significant increases were obtained for the items addressing the self-management skills seeking social support  and palliative emotion regulation , as well as for the scale addressing social skills .Pre-post comparisons of the variables addressing life skills are displayed in P=.01). No significant pre-post differences were obtained in the percentage of persons using cannabis or smoking cigarettes.Pre-post comparisons of substance use prevalence rates are displayed in Within this study, we tested the acceptability and explored the potential effectiveness of a newly developed mobile phone–based life skills training program for substance use prevention among adolescents. The study revealed three main findings: (1) concerning participation, a large proportion of the eligible adolescents who were invited for program and study participation in the setting of a school classroom, participated; (2) concerning program use, the majority of program participants completed the entire program and engaged in program activities; however, regular program use could be improved; and (3) concerning program effectiveness, the initial results derived from this pre-post comparison revealed statistically significant increases in the life skills addressed, a decline in at-risk alcohol use, and stable prevalence rates for tobacco and cannabis use.ready4life. Given the program duration of 6 months and that program participants needed to indicate their mobile phone number, this high participation rate is particularly remarkable and was even higher than for substance-specific mobile phone–based programs conducted in the same setting and using similar recruitment procedures; between 50% and 75% participated in comparable programs to support smoking cessation [The proactive invitation for program and study participation in the school setting, in combination with the offer of a low-threshold mobile phone–based intervention, permitted us to reach 4 out of 5 adolescents for participation in the life skills program essation ,26, wheressation ,40. BeyoParticipation in the program was lower in male adolescents and among those reporting an immigrant background. These findings should be considered for program optimization, for example, by highlighting the relevance of this program for these subgroups or by emphasizing interesting program elements, focusing particularly on these target groups, during program presentations in school classrooms.Overall acceptance of the intervention was good. Nearly all program participants (95%) stayed logged in until the end of the program, which lasted 6 months. The SMS messages were read by almost all program participants (94%), and 3 out of 4 participants reported that they were helpful and perceived the text messages as individually tailored to them. However, 15% failed to engage in any of the 39 program activities, and 52% engaged in fewer than half of the possible activities. On the basis of this finding, there is clearly room for improvement in terms of active program engagement, particularly concerning the picture and message contests, which received the poorest ratings among all program elements. The poor rating for this highly interactive element might be because of the limitations of mobile phone texting to receive and send pictures, which could be implemented more elegantly within a chat-based native mobile phone app.The results concerning the initial effectiveness of this program derived from a pre-post investigation are promising. Data revealed a decrease in perceived stress, an increase in social skills, and increases in two out of the three desirable self-management strategies , whereas no changes were observed in less desirable self-management strategies (avoidant coping and anger-related emotion regulation). The proportion of adolescents with at-risk alcohol use was reduced by a quarter from baseline assessment to follow-up, whereas no significant changes were obtained in the prevalence of tobacco and cannabis use. On the basis of typically increasing levels and frequency of substance use in adolescence and early adulthood , these sBeyond the limitations associated with the pre-post study design, some other study limitations should be mentioned. First, the results are restricted to adolescents without regular cigarette use, as only they were deemed eligible to participate in this general mobile phone–based life skills training. Second, only 50% of the study participants completed the follow-up assessment, which might have biased evaluations of the program and the results on efficacy, even though we controlled for attrition bias in our GEE models. Third, since the study focused on program appropriateness, meaning that we wanted it to be relevant to actual prevention practices, we restricted our outcome assessments to either short forms of, or single items extracted from more extensive validated instruments; furthermore all outcomes were self-reported.This is the first study to test a comprehensive life skills training program for substance use prevention delivered by a mobile phone among adolescents. Our results suggest that this program, which delivers individualized messages and interactive activities integrated within a friendly competition, is both appropriate and promising in its effectiveness. Moreover, this intervention could be easily and economically implemented. On the basis of these initial positive results, a reasonable next step would be to test the efficacy of this program within a controlled trial.Beyond testing the efficacy of digital-delivered life skills training programs, the examination of moderators and mediators of life skills trainings outcome in general remains an interesting question, which should be addressed in future studies.Concerning moderators, it would be of particular interest to examine whether individuals with higher levels of substance use could also benefit from life skills training programs and to compare the effectiveness of these general life skills training programs with substance-specific interventions, for example, mobile phone–based programs for adolescents already consuming specific substances such as tobacco or alcohol -22. ResuConcerning mediators, it would be of particular interest to test which of the life skills addressed and successfully modified in turn might prevent or decrease problematic substance use, for example, results from the ALERT Plus project showed that program-induced changes in perceived social influences, one’s ability to resist those influences, and beliefs about the consequences of drug use mediated the effects on drug use .Another interesting topic which should be addressed in future studies concerns potential spillover effects of general life skills training programs on other mental health conditions. As substance use and other mental disorders, for example, alcohol use disorders and depression, do not emerge as single impairments but rather co-occur ,43, effe