Widespread replication of effective prevention programs is unlikely to affect the incidence of adolescent delinquency, violent crime, and substance use until the quality of implementation of these programs by community-based organizations can be assured.This paper presents the results of a process evaluation employing qualitative and quantitative methods to assess the extent to which 432 schools in 105 sites implemented the LifeSkills Training (LST) drug prevention program with fidelity. Regression analysis was used to examine factors influencing four dimensions of fidelity: adherence, dosage, quality of delivery, and student responsiveness.Although most sites faced common barriers, such as finding room in the school schedule for the program, gaining full support from key participants , ensuring teacher participation in training workshops, and classroom management difficulties, most schools involved in the project implemented LST with very high levels of fidelity. Across sites, 86% of program objectives and activities required in the three-year curriculum were delivered to students. Moreover, teachers were observed using all four recommended teaching practices, and 71% of instructors taught all the required LST lessons. Multivariate analyses found that highly rated LST program characteristics and better student behavior were significantly related to a greater proportion of material taught by teachers (adherence). Instructors who rated the LST program characteristics as ideal were more likely to teach all lessons (dosage). Student behavior and use of interactive teaching techniques  were positively related. No variables were related to student participation (student responsiveness).Although difficult, high implementation fidelity by community-based organizations can be achieved. This study suggests some important factors that organizations should consider to ensure fidelity, such as selecting programs with features that minimize complexity while maximizing flexibility. Time constraints in the classroom should be considered when choosing a program. Student behavior also influences program delivery, so schools should train teachers in the use of classroom management skills. This project involved comprehensive program monitoring and technical assistance that likely facilitated the identification and resolution of problems and contributed to the overall high quality of implementation. Schools should recognize the importance of training and technical assistance to ensure quality program delivery. The recent focus of school-based delinquency prevention efforts has been to identify and replicate effective research-based programs, i.e., programs that have been tested rigorously and achieved positive results in the prevention or reduction of delinquent behavior and substance use. Several programs have emerged as exemplary in meeting these criteria, and have been placed on government and private agency "what works" lists for entities seeking to implement evidence-based programs -6. Once What is missing from this formula, and what has become increasingly more important in prevention research -9, is hoSchools are an ideal environment for widespread dissemination of successful delinquency prevention programs because they contain a universal target population and valuable program facilitators . As a result, many program developers have designed and tested prevention programs that take place in school settings, and many of these programs have demonstrated evidence of positive outcomes for students -20.While schools now have more choices regarding evidence-based programs that meet their needs, successful implementation of a given program is not guaranteed. For example, the National Study of Delinquency Prevention in Schools demonstrated great variability in the implementation of school-based prevention programs, with prevention activities often not implemented with sufficient strength and fidelity to produce a measurable difference in the desired outcomes . In thisThese findings contrast with research trials that reported high rates of implementation fidelity -28. For only work when implemented with a high degree of fidelity, and other research suggests that closer adherence to core components results in stronger participant outcomes [The less successful results found in community-based replications suggest that variability in fidelity increases when programs are widely disseminated ,30. Whenoutcomes ,28,31-36As programs become more widely disseminated, the need to identify factors promoting or inhibiting implementation quality becomes essential. Much of this research has been exploratory, typically based on process evaluations and qualitative evidence . NonetheStaff training is critical for success because it provides the knowledge and skills needed to implement the program, fosters support and commitment to the program, and communicates the importance of program fidelity -42. BoosIt is essential that program staff at all levels of implementation provide strong support for a newly chosen program. At the top level, the project director or coordinator champions the program replication from its inception and throughout implementation. Program fidelity is strongly influenced by the commitment displayed by the site coordinator, who advocates for the program, ensures that program protocols are in place, and identifies and helps resolve implementation problems ,40,49-51Specific program characteristics also can influence the quality of implementation. Program complexity and structure have been associated with successful delivery; programs with clear goals and procedures are easier to implement and less likely to result in deviation ,49,52,53Finally, ongoing and rigorous program oversight is associated with implementation fidelity ,32,54,55In summary, prior literature has described mixed evidence regarding the extent of implementation fidelity of school-based prevention curricula, with some research trials documenting high levels of implementation fidelity, and community-based replications typically achieving far less success. Though some factors related to implementation quality have been identified, very little is known regarding how program activities actually take place during replications, what specific challenges are faced, and how these problems can be overcome . These aThe Blueprints Initiative, funded by the Office of Juvenile Justice and Delinquency Prevention, U.S. Department of Justice, was designed to accomplish these goals . BluepriThe current paper expands upon earlier published findings regarding the process evaluation of one model program, the LST school-based drug prevention curriculum . The preThe current paper summarizes results from the complete LST replication project. We describe implementation outcomes for the full sample of 105 sites (432 schools) after replication of the entire three-year curriculum in all sites. In addition to providing a descriptive analysis of implementation fidelity results , we use multivariate analysis to demonstrate predictors of four primary elements of implementation fidelity . Four research questions are addressed:1) Did the LST program reach the intended, universal population of middle school students?2) To what extent was the program implemented with fidelity; i.e., covering the majority of information and activities in each lesson, delivering all the lessons, using varied teaching techniques, and engaging participants?3) What factors were associated with these four aspects of implementation fidelity?4) What obstacles and barriers were encountered during implementation, and how were they addressed?The LST process evaluation was conducted by Blueprints project staff at the Center for the Study and Prevention of Violence (CSPV), located at the University of Colorado. CSPV's primary goal is integrate prevention research and practice. The "hallmark" project of CSPV has been the Blueprints for Violence Prevention Initiative, an effort to identify and promote the implementation of exemplary evidence-based programs. National Health Promotion Associates (NHPA), Inc, the providers of the LST curriculum, and their cadre of certified LST trainers, were contracted to provide training and technical assistance to implementation sites. Site selection occurred from 1999 to 2001, with the final sample including 105 sites and 432 schools. Sites were comprised of one to 24 schools, and sometimes included multiple school districts. Sites were located in urban, suburban, and rural areas and served students of varying socioeconomic status and racial/ethnic backgrounds.  to the school district. In exchange, schools were required to implement the full three-year curriculum. The first year (level one) included 15 lessons to be taught to all sixth- or seventh-grade students, one to five times per week in at least 50-minute class periods. In the second year of implementation, these students were to receive ten booster sessions (level two), while an incoming cohort of sixth- or seventh-grade students would receive the level one curriculum. In the third year of implementation, eighth- or ninth-grade students received five booster sessions (level three), seventh- or eighth-grade students received the level two curriculum, and an incoming cohort of sixth- or seventh-grade students received the level one curriculum. During the research project, violence prevention lessons  were added to the packaged curriculum. As NHPA considered these lessons optional, and schools had not previously committed to teaching them, the lessons were not required from Blueprints sites.Sites responded to a Request for Proposal (RFP) issued by the Office of Juvenile Justice and Delinquency Prevention and/or applied directly to CSPV (Blueprints). Applications provided program implementation details, including the subject in which LST was to be taught, class size, names of instructors, timelines, and other site-specific information. Each site was asked to identify a local coordinator to monitor program activities, help overcome challenges, and communicate with CSPV (Blueprints) and NHPA. Written letters of commitment from school principals and superintendents also were required.  staff and certified LST trainers from NHPA to verify application information, describe the core elements of the program, explain the research requirements of the project (with a strong emphasis on the need to implement the program with fidelity), assess commitment to implement LST with fidelity, and address local concerns. Selection decisions were based on site readiness and ability to replicate the program. Given the small number of applications received, most sites were accepted into the study, but those that were clearly unprepared  or were unable to fulfil the project's requirements  were not selected.Each site received a two-day training workshop in the first year of implementation, and a one- or two-day workshop in the second and third years to familiarize staff with the program rationale and the key components of each lesson. Training was required for all LST instructors and local coordinators, and was encouraged for school administrators and other support staff.  staff visited sites once per year to conduct informal interviews with LST program coordinators, principals, classroom observers, and some teachers. Discussions focused on the progress of implementation, including support for the curriculum, problems encountered, and solutions achieved. Staff also observed LST classes, usually in conjunction with local observers, to assess the reliability of their information. CSPV (Blueprints) and NHPA staff provided telephone-based technical assistance (TA) to local coordinators as needed during the school year, focusing on implementation progress and achieving solutions to implementation challenges. At the end of each school year, CSPV (Blueprints) provided each site with a written report describing the overall project results, as well as site-specific information regarding the extent of implementation fidelity achieved, obstacles faced and overcome, and recommendations for improvement. Schools could request phone, email, or on-site TA from NHPA trainers throughout the project. , replicated in 42 sites . VariablTeacher reports were based on written mail surveys conducted at the end of each program year, which were collected and sent to CSPV by site coordinators. All surveys were conducted anonymously, and response rates were fairly high: over the three years, about 70% of teachers completed year-end surveys. Multiple teachers implemented LST during the three-year study, though some teachers participated each year and may have responded more than once. Teacher reports were averaged to create site-level scores for each implementation measure. Both independent and dependent variables were assessed at the site level, rather than for individual teachers. This procedure was used because the study aim was to examine the ability of schools as a whole to replicate the LST program with fidelity, and certain site-level characteristics were expected to influence implementation procedures. Scores also were collapsed across program years because each year of implementation covered similar themes and topics. Additionally, feedback on implementation was provided in annual reports to all sites, and all information in these reports was collapsed at the site level to avoid embarrassment to individual teachers in small schools, as well as any repercussions that might occur at the administrative level due to inadequate or incomplete implementation by a teacher.Written mail surveys were completed by local site coordinators at the end of the three-year project. Coordinators reported on 42 items related to program implementation, characteristics of the local school district and program implementers, training and technical assistance, and support for the program. Each item was rated on a five-point scale identifying the extent to which it was a "significant barrier" (rating of "one") or "significant asset" (rating of "five") to implementation as a whole, throughout the project. In all, 104 of the 105 surveys were completed by local coordinators.The overall quality of the training workshop was measured from reports by the site coordinators at the end of the three-year period, teacher reports conducted at the end of each training workshop, and trainer surveys also collected at the end of the workshop. Coordinators rated the overall quality of training workshops from one ("significant barrier to implementation") to five ("significant asset to implementation"). Teachers and trainers rated the workshop on a five-point scale (from "poor" to "excellent"). The three reports were averaged to form the training quality measure .Coordinators rated the extent to which four characteristics related to the LST program  were a barrier (score of one) or asset (score of five) to implementation. These items were combined to form the program characteristics scale .The school characteristics scale  was derived from 13 items rated by coordinators, including staff participation, administrative support, open communication between agency staff, fit between program and agency, cohesion and collaboration, clarity of goals, clear lines of authority, structural stability, champion, facilities, financial support, resources for program, and political climate. Each item was rated on a five-point scale (from "significant barrier" to "significant asset" to implementation).A separate measure was derived from teachers who reported the degree of administrative support for LST, rated on a five-point scale, from "not at all supportive" to "very supportive."Teacher support was based on instructors' overall rating of the LST program on a five-point scale, from "poor" to "excellent."Teachers reported the degree to which parents were aware of the program on a five-point scale, from "unaware" to "very aware."The overall quality of the LST coordinator was rated by Blueprints staff using a three-point scale .Teachers reported the average length of their LST classes in minutes.Classroom observers rated student behavior during lessons on a five-point scale, from "poor" to "excellent."Prior studies have identified four primary elements of implementation fidelity: adherence, dosage, quality of delivery, and participant responsiveness . In thisDuring yearly site visits, Blueprints staff conducted classroom observations with the local observers to validate the accuracy of the information. During the three-year project, 302 joint observations were conducted. Ratings were compared on each pair of implementation checklists. The observer and staff correspondence across all levels and years of implementation was 89.7%, indicating a high level of reliability of the observer information.LST dosage  was based on a question in the year-end teacher surveys that asked instructors to check all lessons that they taught during the year. This question was then coded as a dichotomous measure. If a teacher had taught every lesson, s/he received a score of one; if not, a score of zero was given. An average score was created for each site, based on all teachers and years of implementation.Quality of delivery ("interactive") was assessed as the percentage of the class period spent using the three recommended interactive teaching techniques . This measure was reported by classroom observers on the fidelity checklists. A summary score was created for each site, based on all site observations over the three-year period of implementation.Participant responsiveness ("student participation") was measured by teacher year-end survey responses to the item: "What percent of students participated in LST activities that you taught?" A summary measure was created for each site, based upon the responses from all LST instructors at the site and averaged across the three years of implementation.Results for the research questions are based on teacher and coordinator surveys, observations of lessons (from consultants and Blueprints staff) and qualitative interviews conducted by research staff with key participants. Results are primarily descriptive in nature. The third research question, identifying predictors of implementation fidelity, was analyzed using quantitative data from written surveys and observations. Multiple linear regression was used to identify predictors of the four elements of implementation fidelity. All independent variables were entered into the model simultaneously, and significant predictors (p < 0.05) were identified.all eligible students. At the beginning of each school year, schools were required to submit schedules of implementation that identified the dates and times during which LST would be offered to the targeted population . Schedule adherence was verified by the local classroom observers at each site. When problems arose that prevented teachers from reaching all students, Blueprints staff were usually notified by the local observer, and efforts would be made to resolve the problems. Typically, the lack of instruction was due to a lack of trained teachers . In these cases, a second training or TA visit was held to train additional instructors. Sometimes, schools or teachers delayed in teaching students due to scheduling problems or lack of enthusiasm. For these cases, Blueprints staff worked with local coordinators to motivate instructors to begin teaching the program.A prerequisite of site selection was that schools implement the program with Although 100% exposure was not obtained in every school, all efforts were made by Blueprints staff to ensure the program was delivered to the intended population and that all eligible students received the program. For the most part, this was accomplished successfully. During the three years of implementation, the LST curriculum reached approximately 172,355 students.Our primary measure of implementation fidelity was teachers' adherence to the LST curriculum, defined as the proportion of critical objectives and activities taught during observed lessons. As shown in Table Program dosage – whether or not all lessons were taught, and the average length of lessons – was reported by teachers in year-end surveys. As shown in Table A key aspect of the LST curriculum is variation in instructors' teaching techniques that includes didactic instruction, discussion, demonstration, and behavioral rehearsal as appropriate during lessons. According to observer reports, teachers spent, on average, 37% of class periods facilitating student discussion, 32% using didactic instruction, 20% conducting behavioral rehearsals, and 12% demonstrating skills. Teachers reported high participant responsiveness to the program. On average, across the sites, 89% of the students participated in lessons.As shown in Table These variables demonstrated modest bivariate correlations with the dependent variables that measured implementation fidelity of the LST curriculum . These cases often were related to low or no teacher attendance at required LST training workshops. As explained below, this challenge was faced to some degree by many schools; however these failures represented an extreme problem, or multiple problems, that could not be resolved. Every effort was made to provide support to schools and sites that considered withdrawing from the project, but TA did not always help these sites. For example, make-up staff training workshops were held, but in sites facing organizational upheavals or communication failures, second trainings often were no more successful in ensuring teacher attendance than the initial training workshop.Although all LST instructors were required to attend training workshops, absenteeism often occurred. When absences signaled a clear lack of commitment from the site , schools were asked to withdraw from the project. If absenteeism reflected a lack of communication between school personnel, such as administrators failing to provide substitute teachers, or scheduling other required workshops on the same day, sites were offered make-up trainings. Staff turnover after training was common, and typically delayed implementation until another training opportunity could be arranged. In a few cases, sites did not identify the teacher turnover, and either allowed untrained instructors to deliver the lessons, or chose not to deliver the program to the teacher(s)' classes. Schools could avoid implementation delays by sending additional staff (particularly guidance counselors) to trainings who could teach lessons if needed, but doing so was often difficult for schools to arrange.Many schools struggled to integrate the three-year LST curriculum in their existing schedules, particularly as the program was to be received by all students, ideally in classes lasting at least 45 minutes with fewer than 35 students. The most common barrier to integration was finding time outside of "core" academic subjects, and this challenge increased during the project, just as academic pressures to fulfil standardized test requirements also increased. Placing LST in non-academic subjects was not always the best solution. When students realized their elective courses would be used to teach a curriculum, they could be critical of the program and disruptive during lessons, which was significantly associated with lower teacher adherence to the curriculum. Some schools scheduled LST into short homeroom periods or other free periods, which resulted in less time to teach required material  and often to student behavior problems.Implementation during physical education classes was a common, but not effective solution to scheduling difficulties. Classes were sometimes combined during physical education (PE) and resulted in class sizes of nearly 100 students in one site, which could exacerbate behavior problems. Moreover, participation in discussions and role plays suffered in large classes, as not all students could participate, and some were reluctant to share personal experiences in front of large groups of their peers, particularly those they did not already know. Finally, some PE classes were held in the gym, cafeteria, or even outside, and were a distraction for both students and teachers.Over the three years of the project, many sites integrated the program into their curriculum, sometimes by trying various arrangements until finding a niche. Particularly successful strategies included identifying a subject, such as health, in which similar information was being taught, and replacing that material with LST lessons, or matching the LST curriculum with state or district teaching requirements so that all school personnel felt the time was well spent and not viewed as additional class work.Although teachers and observers generally reported good student participation in lessons, student behavior problems nonetheless occurred with frequency. These issues were especially apparent in large classes and during discussions and behavioral rehearsals. In turn, misbehavior led some teachers to avoid interactive exercises – or to spend too much time managing student behavior problems, which resulted in less time to cover the required material.prevent student misbehavior, and/or reviewed strategies for facilitating discussions and behavioral rehearsals while still covering required material.Classroom behavior problems were difficult to overcome, particularly for instructors from outside the school system who were unfamiliar with students. In these cases, classroom teachers were asked to help manage student behavior. Likewise, if possible in large, combined classes, teachers divided the workload so that one teacher taught while the other monitored behavior. In extreme cases, sites (or research staff) requested TA from LST trainers, who modeled teaching techniques designed to While the measures of support from coordinators, school administrators, and teachers were not strongly related to program fidelity in multivariate analyses, support from key participants could influence program monitoring, training workshops, and other implementation procedures. Enthusiastic local coordinators were able to provide the onsite monitoring and proactive problem-solving that external research staff could not. Conversely, coordinators who lacked interest in the program typically failed to monitor program activities and intervene when needed, such as identifying teacher turnover and arranging new training workshops, or ensuring that LST schedules were being followed. Other coordinators lacked authority to effectively manage the program. When classroom teachers or guidance staff acted as coordinators, ensuring full teacher attendance at training workshops or scheduling LST classes could be difficult, as this required approval from school administrators. Coordinators who were too far removed from the classroom  were often not perceived as credible by teachers, and thus had difficulty communicating with instructors or offering assistance.School principals and district administrators needed to promote the program, when adopting and integrating it in the school schedule as well as during implementation, to bolster enthusiasm from other staff and ensure that lessons were taught. Active administrators introduced the program to teachers and elicited their support, attended teacher training workshops, observed lessons, kept informed of implementation progress, and even taught classes in some cases. In contrast, other principals did not make the curriculum a priority, perhaps due to competing demands and increased pressure to raise students' academic performance. In more extreme cases, a lack of principal support could lead to site failures. In two failed sites, outside prevention agencies had coordinated the project and provided LST instructors, but had not engendered full support from administrators. As a result, when they were unable to continue teaching the program, principals refused to take on the burden. One site could not find a suitable subject in which to teach the curriculum, and the principal was unwilling to make room in the school schedule. Another failed site involved principal turnover, with the new principal overwhelmed with new duties of the job and unwilling to spend time trying to integrate the program into the school curriculum. Research staff solicited administrator enthusiasm and support by requiring principals to sign letters of commitment as part of the application process, as well as through personal visits to discuss the goals of the project, progress of implementation, and administrator involvement in the initiative.Teacher support for the program varied by site and over time. While the majority of instructors had very positive views of the program, others resented the mandate to teach LST, particularly when their input was not solicited, and when they were overburdened with other responsibilities. Some teachers did not support LST because they felt similar material was already being taught in the school, they disliked the content or theory of the program, or they felt other drug prevention curricula were better. Other reasons for a lack of teacher support included concerns about being observed, or feeling that project guidelines regarding fidelity were too rigid and did not allow for teacher creativity and flexibility.Teacher dissatisfaction sometimes resulted in instructors deviating from the curriculum by supplementing lessons  or deleting information, activities, or entire lessons. Some teachers were observed telling students that they had to "get through" LST lessons before they could begin other work. Not surprisingly, students in these classrooms tended to be uninvolved and disruptive. When instructors from outside the school taught lessons, classroom teachers often appeared uninterested in the material (some were even observed reading newspapers and paying bills), and students typically responded with boredom and restlessness. Instructors' lack of buy-in also contributed to site failures. If both instructors and administrators were reluctant to champion the program, the likelihood of overcoming challenges was diminished.During implementation, CSPV staff met with as many instructors as possible to listen to their concerns, thank them for their support, and recommend that those with problems seek technical assistance from trainers. In site visits and year-end reports, coordinators and school administrators were encouraged to foster teacher support by scheduling regular meetings with staff, and providing guidance counselors or others to co-teach lessons if teachers requested such assistance. Even if this advice was not followed, teachers who did not enthusiastically endorse the program were sometimes observed to effectively deliver lessons, which may help to explain the lack of significance between teacher support and implementation fidelity.Widespread replication of effective prevention programs is unlikely to affect the incidence of adolescent delinquency, violent crime, and substance use until the quality of implementation of these programs by community-based organizations can be assured. This paper presents the results of a process evaluation focused on identifying the extent to which schools participating in the Blueprints for Violence Prevention Initiative were able to successfully implement the LST drug prevention program. In addition, the project identified factors that promoted implementation quality, challenges that were faced during replications, and the degree to which problems were overcome.The process evaluation demonstrated very high rates of implementation fidelity among the sites and schools participating in the project. According to observer reports, sites delivered, on average, 86% of the program objectives and activities required in the three-year curriculum. Teachers were observed using all four recommended teaching practices  and student participation in lessons was good. Teachers and site coordinators also reported strong implementation outcomes and satisfaction with the program. For example, end-of-year surveys demonstrated that 71% of the teachers delivered all the required LST lessons over the three-year period, class length was in accordance to dosage requirements, and satisfaction with the curriculum was better than average. Program coordinators rated the LST program favorably with regard to the quality of the materials, flexibility, time required, and complexity. Another measure of the success of the program was shown by the high rate of student participation. On average, 89% of students participated in lessons.Factors related to each of the four components of implementation fidelity  were also assessed in four multiple regression models. LST program characteristics and student behavior were associated with outcomes in two of the four models. Sites whose coordinators had rated the LST program favorably with regard to quality, flexibility, complexity, and time required had higher levels of teacher adherence and dosage. Program developers are increasingly producing detailed manuals that specify the nature of the required program components . AttractBetter student behavior was related to higher teacher adherence and use of interactive teaching techniques. Teachers who spend excessive amounts of time reprimanding and striving to maintain control of a class have less time to teach the lessons and engage students in meaningful discussion and behavioral rehearsal. Teachers who are not adept at managing their classes may avoid the use of interactive techniques for fear of losing control of the class. Our own observations in classrooms showed that teachers with poor classroom management skills often lost control of the class when using interactive techniques. This suggests that schools should consider teacher training in classroom management skills prior to adopting programs that use interactive techniques, such as LST.Two other variables were marginally related to teacher adherence: the quality of the local coordinator and a greater amount of time spent teaching each lesson. In the absence of a strong and proactive coordinator, programs can drift. A good coordinator can provide direction, leadership, and motivation to keep implementation on track. Good coordinators maintained contact with teachers, identified potential problems, and worked to resolve them before they became major obstacles. Allowing adequate time to teach each lesson was also important. Qualitative interviews with program staff provided additional support for this finding. Instructors frequently reported to research staff that it was difficult to cover all the required information, even in a 50-minute class period. Time constraints were exacerbated when teachers had to use instruction time to manage student misbehavior.It is difficult to interpret the finding that greater teacher support for the program was related to less frequent use of interactive teaching techniques. We suspect that many of the teachers lacked the skills and experience to use the interactive methods. They may have been very motivated and supportive of the program, but unable to adjust to the more frequent use of these teaching techniques. Some motivated teachers may have limited their use of the interactive techniques in classrooms that contained students who were difficult to manage. In fact, good student behavior and the use of interactive techniques were positively correlated. LST training workshops exposed instructors to these teaching techniques; however, instruction in effective classroom management techniques was not included, and more in-depth training in the efficient use of these techniques may be necessary.Though research on factors related to implementation fidelity is growing, this is a relatively new area of study and few other studies to date have relied on quantitative analysis to identify these factors. In the Blueprints Initiative process evaluation of 42 sites replicating eight model programs, multivariate analyses showed several factors related to implementation fidelity, including quality of technical assistance, ideal program characteristics, consistent staffing, and community support . The NatUnlike the National Study of Delinquency Prevention in Schools, the Blueprints Initiative provided schools with program materials, teacher training, and technical assistance to replicate the LST program. In addition, sites were screened in advance to determine their readiness and support to implement the program with fidelity. Throughout the project, Blueprints staff provided program monitoring to ensure that curriculum activities were taking place and to encourage fidelity. One-third to one-fourth of all lessons were observed. Given this level of support and encouragement to implement with fidelity, implementation of the curriculum did not occur under typical, "real world" conditions. Thus, schools participating in this project may not be representative of all schools that might choose to implement LST, and the support provided may have resulted in higher implementation levels than might otherwise be observed. In fact, the results demonstrated implementation fidelity rates even higher than those found in LST research trials and some replication efforts. It may be that the most important predictor of implementation quality was the technical assistance provided, and that this support overshadowed other factors that might be more important in community-based replications that do not receive this level of technical assistance.Given the nature of this project, the results of the multivariate analyses should be viewed with some caution. Most of the independent variables were assessed using self-reported information from LST instructors and local coordinators. Not all teachers completed surveys, and it is possible that teachers who were less supportive of the program did not participate in the assessment. In addition, data were cross-sectional, and causal inferences regarding predictors and outcomes could not be made. These limitations emphasize the need for additional studies assessing predictors of implementation quality in community-based replications of prevention programs. More research is needed to identify the degree to which communities can replicate programs successfully, and more quantitative analyses of factors that influence the successful adoption of new programs are needed. In particular, studies utilizing multiple respondents, longitudinal designs, and random assignment are needed.Despite the levels of program monitoring and support provided in the Blueprints Initiative, it is telling that schools nonetheless faced many challenges during implementation. Interviews with program staff indicated barriers related to finding room in the school schedule for the program, with schools trying to avoid taking time away from academic subjects but also risking student resentment if electives or free time was used to teach LST. Most schools struggled to some extent with gaining full support from key participants, including site coordinators, instructors, principals and other school administrators. Finally, student misbehavior and classroom management difficulties were reported by many teachers, particularly when trying to implement the interactive components in the curriculum.proactive TA (versus waiting for schools to contact TA providers) was needed to identify and solve implementation challenges.In most cases, schools were able to overcome barriers, at least over the course of the three-year project. Schools also varied in their willingness to identify challenges to research staff. Most schools seemed reluctant to ask for TA, even though they were strongly encouraged at the start of the project and in annual reports to utilize the free technical assistance available. In many cases, Blueprints staff did not learn about problems until site visits were made, and requests for visits by LST trainers were rare. We quickly learned that "no news was good news" did not apply to the schools participating in this project and that During the past decade, we have learned much about the importance of implementation fidelity in achieving effective outcomes, and about what is required to attain a high-quality implementation. The primary lesson learned in this project was that schools can effectively replicate evidence-based drug prevention curricula, including teaching the majority of required lessons, content, and activities in a manner that engages students. Doing so involves much planning and problem-solving, and schools must be ready to encounter challenges. Even when problems are encountered and solved, they may reappear later in implementation and have to be resolved again. The provision of technical assistance and implementation monitoring is critical for identifying and overcoming barriers to implementation. Implementation fidelity was especially high in this project due to the level of TA support provided by NHPA and the implementation monitoring by Blueprints staff. Under natural conditions, schools may not achieve the same level of fidelity as found in this project, but even without this high level of support schools can still improve implementation fidelity (and hence outcomes). Purchasing a curriculum and asking teachers to implement, in the absence of training, support, and monitoring, will seldom be sufficient. School administrators must be proactive in supporting teachers' efforts to replicate programs. This includes choosing programs carefully to ensure fit, ensuring that teachers are trained in the program model and in classroom management skills, building an internal mechanism of ongoing support , and instituting at least some minimal form of internal monitoring that provides corrective feedback to teachers and administrators regarding implementation.The author(s) declare that they have no competing interests.The replication project was directed by SFM, and AF and SA were project managers at different time intervals throughout the project, overseeing field staff and data collection. SFM conceived of the study, and SFM and AF participated in the study design, statistical analyses, and writing. AF had a major role in preparing the first draft. SA prepared the file for analysis. All authors read and approved the final version.LifeSkills Training Implementation Fidelity – Site Selection and Training. Detailed information is provided on site selection and training during the course of the grant.Click here for file


Popliteal artery entrapment syndrome (PAES) is a relatively rare condition that occurs in young patients as a result of anomalous anatomic relationships between the popliteal artery and the surrounding musculotendinous structures. Patients usually lack atherogenic risk factors and most commonly present with intermittent claudication in the early stages. In the later stages of undiagnosed PAES, acute ischaemia can occur as a result of complete arterial occlusion or embolism. Hence, early diagnosis and surgical release of the entrapment is crucial for good operative outcome and to prevent limb loss. The anatomical basis of popliteal entrapment was first described by Stuart in 1879 . The conA 24-year-old fit-and-healthy ex-army officer presented with a two-day history of a cold, numb, and painful left lower leg; he had been doing vigorous exercises two days prior to admission. Over the past few months, the patient had experienced similar worsening leg pain after running long distances. Apart from smoking (5 pack years), the patient had no other significant cardiovascular risk factors.Physical examination revealed a regular heart rate of 60 beats per minute and a blood pressure of 120/80 mm Hg. There was no palpable abdominal aortic aneurysm. Examination of the right leg was unremarkable. On the left side, there were normal palpable femoral and popliteal pulses, but no palpable distal pulses. The left foot also appeared paler; however, motor and sensory functions were intact.An angiogram revealed a thrombotic occlusion of the proximal half of the popliteal artery and a small embolus in the mid-peroneal artery . IntraarAn MRI scan was subsequently performed and showed the medial head of the gastrocnemius muscle going between the popliteal artery and vein where it inserted in a more lateral position . Having Various classifications of PAES exist in the literature. The most commonly used one was proposed by Whelan  and diviThe presenting symptoms are variable and include leg swelling, aching pain, rest pain, and cramping of the calf. Physical signs are usually absent at rest, until complications develop. In young persons, symptoms are limited to intermittent claudication  and thisAngiography is the classical screening and diagnostic tool in PAES . It can The most common and successful treatment option is muscle division to release the entrapment. If there is significant delay in diagnosis, the popliteal artery may become occluded, stenotic, or aneurysmal . In suchPAES is a rare but potentially limb-threatening condition affecting predominantly young male adults. This syndrome is difficult to diagnose and, therefore, poses a diagnostic pitfall. Awareness of this entity is a prerequisite for correct and prompt diagnosis. Careful history and physical examination is of utmost importance. It should be included in the differential diagnosis of acute popliteal artery occlusion or claudication in young patients with no cardiovascular risk factors. Early surgical intervention to release the popliteal artery is the treatment of choice and is important for good operative outcome.


Laboratory diagnosis of acute infection of hepatitis E virus (HEV) is commonly based on the detection of HEV RNA, IgM and/or rising IgG levels. However, the profile of these markers when the patients present have not been well determined. To clarify the extent of misdiagnosed sporadic hepatitis E in the initial laboratory detection, serial sera of 271 sporadic acute hepatitis cases were collected, detected and the dynamics of each acute marker during the illness course were analyzed. 91 confirmed cases of hepatitis E were identified based on the presentation of HEV RNA, IgM or at least 4 fold rising of IgG levels. 21 (23.1%) hepatitis E cases were false negative for the viral RNA and 40 (44.0%) for rising IgG, because occurrence of these markers were confined to acute phase of infection and viremia had already subsided and antibody level peaked when these patients presented. IgM was detected in 82 (90.1%) cases. It is the most prevalent of the three markers, because the antibody persisted until early convalescence. Nine cases negative for IgM were positive for rising IgG and one was also positive for the viral RNA; all of these nine cases showed high avid IgG in their acute phase sera, which indicated re-infection. In summary, it is not practicable to determine the true occurrence of sporadic hepatitis E. Nevertheless, it could be closely approximated by approach using a combination of all three acute markers. Hepatitis E Virus (HEV) has been recognized to be a major cause of outbreaks associated with fecal contamination of drinking water for decades The virus afflicting humans consists of a single serotype and 4 major genotypes. Genotypes 1 and 2 have only been isolated from humans and are mainly distributed in developing countries. In this setting they cause large water borne outbreaks and sporadic cases and are associated with a high mortality among pregnant women and individuals with chronic liver disease Hepatitis E is diagnosed by detecting viral RNA (RT-PCR) in the serum and/or feces during the incubation period or early acute phase of disease, or, more commonly, by demonstrating IgM anti-HEV or a rising titer of IgG anti-HEV in the serum during the late acute phase or convalescent phase of the illness 1488 sporadic possible hepatitis cases presenting with complaining of fatigue and/or loss of appetite for at least 3 days were enrolled . Serial Among 91 hepatitis E cases, acute marker profiles of 82 cases are compatible with primary infection, reflecting a vigorous IgM response, a relatively weak and transient IgG response with production of low avidity IgG and a relatively protracted viremia. The remaining 9 cases were positive for rising IgG levels and one was also positive for RNA, but all were negative for both IgM and low avidity IgG . Such reOne patient had marginal level of IgM anti-HEV on day 3 (with IgM S/Co of 2.1) and day 26 (with IgM S/Co of 1.7), but negative for HEV RNA. The IgG anti-HEV was at low level, had no notable rising (3.8 Wu/ml on day 3 and 3.7 Wu/ml on day 26), and the avidity were high (72.6% on day 3 and 79.0% on day 26). Hence this case was defined as possible hepatitis E case.The remaining 179 cases were negative for all three markers simultaneously, hence they were diagnosed as non-E hepatitis, included 2 cases positive for HAV IgM, 19 cases positive for HBc IgM and 3 cases positive for HCV IgG.Diagnostic performance by rising IgG, RNA and IgM individually and in combination was assessed . For calHEV RNA is most commonly used as acute markers in routine diagnosis of hepatitis E. IgM anti-HEV was increasingly used in routine diagnosis since its reliability been dramatically increased by using antigens that contained immono-dominant epitopes of the virus and became commercially available in many countries recently However, most published data for the performance of these tests were obtained based on samples confirmed by viral RNA, or samples positive for at least one referenced assay To avoid sampling bias, study subjects were consisted of 271 cases of acute hepatitis consecutively presented over 12 months period with complaints of constitutional signs, such as anorexia, fatigue and etc., for 3 days and abnormal ALT levels ≥2.5 ULN. The antigenic cross-reaction of human HEV with other pathogens had not been reported, hence substantially rise of IgG anti-HEV levels was generally considered as specific marker of acute infection. However, false positive of RNA or IgM might occur during operation. Therefore, diagnosis of hepatitis E based on RNA or IgM was further confirmed by each other or by the presence of low avidity IgG in acute phase serum. False positive diagnosis by this approach is considered unlike. Exclusion of hepatitis E was indicated by a negative finding for all the 3 markers simultaneously. The fecal samples of the patients had not been collected in this study. However, it is not likely that the sensitivity of RNA detection would be higher if fecal samples be detected, because the viral shedding period in the serum is usually similar to or a little longer than that in the feces in most hepatitis E patients 91 patients were diagnosed with hepatitis E. Occurrence of rising IgG and viremia was largely confined to the acute phase of the infection during the first 4 weeks of onset of symptoms. Onset of symptoms is innocuous, however, and presentation was delayed to up to 21 days after onset of symptoms, when IgG antibody levels had already peaked among 42.9% of patients and viremia had subsided among 22.0% of patients. HEV IgM persisted for the longest period until early convalescence about 16 weeks after onset of symptoms and the marker was detected among 82 of the patients. Detection of this marker was variously accompanied by at least one of the other two markers or by the presence of low avidity IgG antibody, reflecting a vigorous IgM response attended by production of low avidity IgG which is compatible with primary infection. The remaining 9 patients yielded a positive finding for rising IgG and one was also positive for viremia, but all were negative for both IgM and low avidity IgG. These acute marker profiles reflect a weak IgM response attended by production of avid IgG compatible with re-infection.Under the above described clinical setting, it was evident that diagnosis is best achieved by combination of all 3 markers. Sensitivity achieved by this approach depends on clinical settings; it is highly sensitive (100.0%) for cases attributed to primary infection, but substantially lower (57.1%) for cases attributable to re-infection, supposed due to the natural appearance of re-infection as limited viral replication and limited induction of IgM anti-HEV. In present study area, which is endemic for HEV genotype 4, assume the sensitivity of rising IgG for re-infection is similar as that for primary infection , and the sensitivity of RNA for re-infection remains to be 11.1% (1/9), then the combined sensitivity of RNA and rising IgG is 61.9%, the expected number of re-infection is 14.5. Under this setting, the expected hepatitis E among 271 acute hepatitis were 96.5 instead of 91; the overall sensitivities of three acute markers were estimated to be 73.6%, 85.0% and 53.9% for RNA, IgM and rising IgG respectively. The sensitivity of combination of the three acute markers is estimated to be 94.3% and negative predictive value is 96.8%; failure of diagnosis occurred mainly in re-infection.The approach in the present study affords a retrospective diagnosis and is valuable for epidemiologic studies. In routine practice, diagnosis is commonly based on detection of HEV RNA and/or IgM usually in single acute samples. False negative associated with such routine approach is mainly due to re-infection and sensitivity achieved by combination of both markers was estimated to be 86.0%, which is very similar as that of 85.0% achieved by HEV IgM alone. Sensitivity of HEV RNA and rising IgG is substantially lower (73.6% and 53.9% respectively), because viremia has already subsided and/or antibody levels had already peaked in substantial number of patients at presentation. In low endemic areas such as in Europe and the US, on the other hand, sensitivity achieved by these markers is expected to be higher, because re-infection would be less common.In conclusion, the results show that it is not practicable to determine the true occurrence of sporadic hepatitis E. Nevertheless, it could be closely approximated by approach using combination of all three acute markers. Deviation from true occurrence of hepatitis E is higher for high endemic than low endemic areas.In a group of community clinics and hospitals in rural townships in eastern China, 1488 possible hepatitis patients who suffered from fatigue and/or loss of appetite for at least 3 days and had an elevated alanine-leucine transaminase (ALT) level were enrolled. Informed consent in writing was obtained from each patient and the study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki. Independent Ethics Committee approval was obtained from the Ethics Committee of Jiangsu Provincial Center for Disease Control and Prevention.Acute hepatitis was defined as an acute liver damage evidenced on presentation by abnormal ALT levels ≥2.5 fold upper limit of the normal levels (ULN). Acute hepatitis cases whose presented sera were collected during time window of 3 to 21 days post-onset and were collected for at least one another follow-up sera were included for final analysis. Serial sera were collected from 271 of such consecutive cases at 3 to 21 days after onset of symptoms (6.7±3.7 days), and during convalescence 9 to 136 days after onset of symptoms (25.6±18.1 days). Additional serum samples were collected from some of the patients (n = 87) at later times up to one year after onset of symptoms.Confirmed hepatitis E cases were defined as: 1) at least 4 fold rising IgG levels in paired sera; 2) RNA(+), confirmed by IgM(+); or 3) IgM(+), confirmed by low avidity IgG in acute phase serum. A possible hepatitis E case was defined as positive for HEV RNA or IgM but can not be confirmed or excluded by antibody dynamics.5′-CTGTTTAA(C/T) CTTGCTGACAC-3′, nt6260–6279) and E5 (5′-(A/T)GA(A/G) AGCCAAAGCACATC-3′, nt6568–6551) in the first round of PCR and primers E2  and E4 (5′-TG(C/T)TGGTT (A/G)TC(A/G)TAATCCTG-3, nt6486–6467) in the second round. PCR cycling conditions for both rounds consisted of 35 cycles of denaturation at 94°C for 30 sec, annealing at 53°C for 30 sec, and extension at 72°C for 40 sec.Serum samples were tested for the presence of the HEV RNA by reverse-transcript PCR (RT-PCR) as previously described The levels of IgM or IgG antibody against HEV were determined by commercial enzyme-linked immunosorbant assays (ELISA)  according to the manufacturer's instructions. These kits are based on a recombinant antigen contained conformational immuno-dominant epitopes corresponding to amino acid residues 394 to 606 of the major structural protein specified by ORF 2 of the HEV genome All specimens were also tested for IgM antibody against hepatitis A virus (HAV-IgM), IgM antibody against hepatitis B core protein (HBc-IgM), hepatitis B virus surface antigen (HBsAg), and antibody against hepatitis C virus (HCV-Ab) using commercial ELISA kits .www.OpenEpi.com, updated 2009/20/05, accessed 2009/01/10).Data were expressed as mean ± SD. Student's t test was used for continuous variables. Differences were considered to be significant for P value <.05. The statistical analysis was performed using OpenEpi (Open Source Epidemiologic Statistics for Public Health, Version 2.3.


This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health.Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms.This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings.ISRCTN24952438 The social and financial cost to the individual and to society of unintended pregnancy is substantial and giving birth as a teenager is associated with a higher risk of negative consequences for both the young mother and child ,2. In de® [® was created by 'RealityWorks'® which manufactures and sells the Infant Simulators [The Virtual Infant Parenting (VIP) Program is a school-based pre-conception program originally developed by the Swan Hills Division of General Practice in conjunction with the North Metropolitan Health Service  in a preventive response to high rates of teenage pregnancy across their region ,12. The ® . The promulators ,14. The mulators . In 1997mulators ,12. Postmulators ,17.Infant Simulator based programs are widespread in United States, Puerto Rico, Canada, Mexico, United Kingdom, Republic of Ireland, Australia, New Zealand, Japan, Germany, Netherlands, Austria, Switzerland, Italy, Belgium, Denmark, Luxemburg, Costa Rica, El Salvador, Nicaragua, Panama, Poland, Iceland and Finland . DespiteOne of the difficulties in developing and providing programs aimed at improving sexual health behaviours, reducing sexually transmitted infection and avoiding teenage pregnancy has been a lack of evidence about what works. Observational studies in adolescent pregnancy prevention (across settings) may overestimate positive program effects compared to randomised trials . In a meWe are not aware of any other randomised research or publications investigating the longer-term pregnancy and birth outcomes of participation in a school-based Infant Simulator program. This paper documents our study protocol and does so in a way that is consistent with the guidelines for the reporting of a randomised controlled trial and, in particular, the extension of the CONSORT statement for cluster randomised trials  and pragThe VIP Program's overarching goal is to reduce the individual and population health burdens associated with early teenage parenthood and unintended pregnancy. This research study aims to evaluate the VIP program against its specific stated objectives. Both the VIP program objectives and the study hypotheses pertain only to the individual level and not to the school/cluster level.The specific objectives of the VIP program are to demonstrate that 13-15 year old girls participating in the VIP program will:1. Delay pregnancy.2. Have fewer unplanned births and/or induced abortions.3. Develop and maintain health sustaining behaviours before and during pregnancy.4. Avoid health risk behaviours associated with an increased risk for low birth-weight children (e.g. smoking during pregnancy).5. Improve knowledge, awareness and access to appropriate health care and other community supports for pregnant teenagers.6. Have healthier early maternal and child health outcomes (for those that do have a live birth during their teenage years).Relative to the non-intervention arm, participants in the experimental arm of the study will have:1. A reduction in rates of teenage births.2. A reduction in teenage induced abortion rates.3. Higher self-efficacy to make informed decisions relating to pregnancy, by understanding the responsibilities associated with having a child through the virtual parenting experience.4. An increased knowledge and/or use of services and resources relating to having a child, in the areas of nutrition, exercise, immunisation, contraception, body image, sexual and mental health, prevention of injury, smoking, alcohol and illicit drugs, SIDS, postnatal depression and breastfeeding.5. Healthier child and maternal health outcomes .The evaluation design for the VIP Program is a pragmatic school-based cluster randomised controlled trial. Although the VIP Program is targeted at an individual level, a school-based clustered design was considered necessary to limit contamination with control participants. In previous pilot studies there was anecdotal evidence of students organising social get togethers such as "sleepovers" while taking care of Infant Simulators and thus contamination was a real concern. Cluster randomisation additionally allowed pragmatic evaluation of the implementation of the VIP Program in schools from a process point of view.This pragmatic trial was conducted in all participating schools physically based within the catchment areas of the three metropolitan health services encompassing the entire metropolitan region of Perth, Western Australia. The East, North and South Metropolitan Health Services employ the School Health Nurses who delivered the VIP Program. Perth is the fourth largest city in Australia with the metropolitan region having a population of 1.5 million . The recAll metropolitan government and independent high schools in metropolitan Perth (excluding Catholic schools) were invited to participate in the study. Overall, 57 of the 66 invited schools enrolled in the program (86%). The government school participation rate was higher (51/54 or 94%) than that for non-government schools (6/12 or 50%) due to the limited availability of School Health Nurses for program implementation in private schools. Twenty-nine schools were randomly allocated to each arm of the study.Individual participants were females aged 13-15 years of age (in Year 9 or 10) at the time of recruitment. All eligible students in the schools allocated to the intervention group were invited to participate in the VIP program. Students from both the intervention and control groups were invited to participate in a prospective study of teenage pre-conceptual health knowledge and behaviour. The participant flow is described in Figure For the intervention arm only 5 students per school per week could participate in the program due to the availability of both School Health Nurses and Infant Simulators. To achieve the sample size required, recruitment continued over 2 years in most schools . For study administration purposes and the limiting factor of having a maximum of 50 Infant Simulators operating over any one weekend the participation of the health services was staggered, with the North Metropolitan Health Service starting first, then the East and then the South. As each school completed implementation, another school started in the next health service region. In each new school year recruitment at the individual level recommenced; the study was active in each of the health services over a period of at least 3 years.Catholic schools and male single sex schools were excluded from participating in the trial. All other schools within the metropolitan region of Perth Western Australia were approached for participation.In each of the intervention and non-intervention trial arms, all females in either year 9 or 10 were approached to participate. Male students, and female students who were pregnant or already had a child, were not actively recruited or enrolled into the study. Males were excluded from the trial due to the primary outcome being teenage pregnancy and birth outcomes along with an inability to accurately and ethically determine the male donor/contributor to a pregnancy.Randomisation was performed at the cluster level with a table of random numbers  by a researcher who was blind to the identity of the schools. After initial recruitment one government school was excluded from the intervention arm after it was detected that the study's Individual Recruitment Protocol was not adhered to. Individual participants were not blinded to their group assignment and upon giving consent were aware whether they were participating in the VIP intervention or control arm of the Trial.Written active consent from both a parent/guardian and the participant was required by the Ethics Committee's to access data for the longitudinal component of the research study until the participants reached the age of 20 (intervention and control arms). The consent specifically included permission for the research team to access data relating to pregnancy from hospital administrative records and abortion clinics. In a bid to maximise participation rates, four additional research staff were recruited to support School Health Nurses in their recruitment efforts. Despite best practice recruitment procedures, approved incentives and significant time and resources, the participation rates at the student level remained relatively low . Incentives ranged from nothing to a chocolate Freddo Frog, or a single movie ticket. The study budget did not allow for incentives; the movie tickets were donated to the research trial and the chocolate frogs were provided by the School Health Nurse at their own discretion.® Baby Think It Over Program. The adaptation was developed by the Swan Hills Division of General Practice, the Coastal and Wheatbelt Public Health Unit and the North Metropolitan Population Health Unit [The VIP program is a Western Australian adaption of the Reality Workslth Unit ,12. The lth Unit -39 and aThe VIP program was implemented as a standardised intervention by School Health Nurses over six consecutive days. There were four main components to the VIP Program curriculum: (1) four educational sessions in small groups of 4-5 girls; (2) a comprehensive reference workbook covering all the pre-conception health issues addressed through the program; (3) a video documentary of teenage mothers talking about their own experiences; and (4) instruction in care of the Infant Simulator which replicates the sleeping and feeding patterns of a six-week old infant.All VIP participants took part in four educational sessions of 40 minutes duration (one school period) conducted in small groups of four-five girls by the School Health Nurse (SHN). In comparison, the Baby Think It Over Program does not stipulate the discipline of the person  to implement the program with the students; however it does recommend small group sessions as a supplement to the virtual parenting experience with the Infant Simulator.The educational sessions were delivered during school time, but outside the traditional class setting; where possible they were delivered in the school health clinic. The focus of the first session was preconceptual health covering issues of contraception, STIs, drug use during pregnancy, nutrition, immunisation, pregnancy choices and health care during pregnancy. Depending on availability and resources, the first session was either delivered by the SHN in conjunction with a local "youth friendly" GP or, if the GP was unavailable, the SHN delivered the session alone with the aid of a 10 minute video of a mock preconception health visit to a General Practitioner. The second session provided an 'Introduction to Parenthood' and introduces the student workbook and asks students to plan their support network for the virtual parenting experience. The third session focused on 'Baby Familiarisation' which involved training the students how to care for the Infant Simulator. During this session students formally receive and name "their baby". Where possible this session was conducted in the last school period on a Friday so that the students were able to take "their baby" home. If school scheduling prevented this session to occur during the last school period for the week then the session was conducted during the day and the students then met the School Health Nurse after school to pick "their baby" up. At the end of the 'virtual parenting experience' a fourth and final session was conducted  by the SHN, which included a debriefing and an educational component on contraception; a computerized record was downloaded from the Infant Simulator and printed for feedback and discussion with the participants.® Baby Care Book. The Reality Works® Baby Care Book included information about; how to care for and hold the Infant Simulator, car seat safety, Sudden Infant Death Syndrome and Shaken Baby Syndrome. The VIP Workbook included additional information on nutrition, exercise, immunization, contraception, body image, sexual and mental health, prevention of injury, smoking, alcohol and illicit drugs, SIDS, breastfeeding, sexually transmitted infections, post-natal depression, the economic implications of parenthood, the need for a support network, support services, and the importance of responsive care and stimulation for infant health and early brain development. Some worksheets were completed in session times while others required completion at home. In addition the Reality Works® content was adapted to reflect the Australian context in relation to service providers and local regulations. Participants were able to keep their VIP Workbooks for future reference.Across the intervention period all participants completed a comprehensive reference workbook covering all the issues addressed through the program; The VIP student workbook was a significantly enhanced version of the Reality WorksThe third component of the VIP Program is the "Talking Realities Video". The video was developed specifically for the VIP Program in conjunction with Murdoch University and the Balga Teen Family Centre . The video is a documentary series of four non-judgmental interviews with teen mothers talking about their own experiences. Each mother talks about how they got pregnant, their family, friends and general public's reaction to their pregnancy and the practicalities and pragmatics of being a teen mother . The Video runs for 30 minutes but is broken into 3 sections so that the School Health Nurse could run 10 minutes of the Video in each of the small group educational sessions .®" Infant Simulators that were released by Reality Works® in 1999. The Simulators replicate the sleeping and feeding patterns of a six-week old infant. It is a life-like model that is 46 centimetres long and weighs approximately three kilograms. The Infant Simulator displays infant behaviours such as different forms of crying, which are programmed to occur with a similar intensity, frequency and duration as those observed in real infants. To 'settle' the 'baby' when it cries, participants carry out various 'parenting' behaviours such as simulated breast-feeding, changing nappies and holding the infant while rocking or burping it. Crying is also triggered if the infant's head is not properly supported or if the infant is handled roughly. The 'baby' continues to cry until it has been sufficiently held and gently comforted by the participant.The VIP Program utilised the "Original RealCareThe Simulators were considered too disruptive to be operated during school lessons and thus students did not care for the Simulators during school hours. Students were provided with a phone number they could call for support during the weekend if needed. During the final debriefing session, participants were presented with a 'Certificate of Achievement'.All of the VIP Program resources were provided to each school by the research team and the Infant Simulators were purchased by and remain the property of the Trial.Prior to implementation all administering School Health Nurses and relief nurses were trained in the delivery of the VIP Program and each nurse was provided with a Training Manual. The training also covered sessions delivered by authors A, D, E and G on research evaluation and the importance of maintaining program consistency within the practical realities of working in the school system. Research staff supported the School Health Nurses in the delivery of the program until they were able to consistently administer the program independently. In all circumstances the School Health Nurses were to deliver the program by following the student workbook, showing the videos, and programming the Infant Simulators using the same schedule (so that each participant had to go through the same program and length of running time).Research staff were in weekly communication with the School Health Nurses during the recruitment and implementation of the program, to provide support where required and to monitor and maintain program integrity.The School Health Nurse manual was provided to each Nurse during their initial training session. The manual was to be used as a guide and resource and to be retained for reference in their school. The Manual provided an introduction to the Program including its aims, objectives and evaluation design; Program overview and flowchart; instructions for gaining consent; an overview of each of the four program sessions; a Program checklist; Instructions for programming the Infant Simulator; and information linking the VIP program to student outcomes within the Western Australian curriculum.In all circumstances the School Health Nurse programmed the RealCare Infant Simulator using the same program, ensuring that every student had the same Simulator behaviour from Friday afternoon through to Monday morning. Utilising the Original RealCare Infant Simulator Programming Schedule the School Health Nurses were instructed to delay the program start to one hour after school providing the student some time to get home and organised. The Simulators were then to start using program 1 for day 1 (Friday), Program 2 for day 2 (Saturday), Program 3 for day 3 (Sunday), and Program 4 for day 4 (Monday). Each participant "cared" for their "baby" for 64 hours. An ID bracelet is strapped to the participant's wrist. This ID is required for the Infant Simulator to respond i.e. the Infant Simulator will only respond to and record the "care" of the participant.A pregnancy outcome (either a live birth or induced abortion) is being determined through tracking participants via the Western Australian Data Linkage System (WADLS). The WADLS maintains a linked database of administrative health records including births and deaths, hospitalisations in private and public hospitals, and the midwives data collection, which records information on all births. The system uses a multi-staged probability method of matching based on key identifiers such as name, date of birth and address . A data While it is a legal requirement for all abortion providers to report induced abortions to the WA Abortion Notification System, the reporting is anonymous. The WADLS had previously only linked participants' abortion records in cases where the abortion was performed in a hospital or a facility accredited for day surgery. Such facilities are required to submit information to the Hospital Morbidity Data System (HMDS), but other clinics are not. It is currently estimated (based on data from the WA Abortion Notification System) that one-third of all abortions performed on girls under the age of 20 are in facilities which are not required to report to the HMDS . As such, the research team gained access to induced abortion data directly from these clinics. In the case of one major clinic that did not begin reporting to the HMDS until July 2007, the clinic was approached directly for access to historical records of abortions that had occurred since this Trial commencement. Relevant data on study participants has been sought from all facilities where induced abortions are performed in Western Australia and as a result of this study the information obtained from the review of the records of clinics which did not report to HMDS have now been entered into the WA Data Linkage System.Participants were assessed by a self-complete questionnaire to determine whether the program had immediate, short or longer-term impact on participant knowledge and attitudes towards pregnancy and parenting or on their health behaviours. Instruments and measures for the questionnaires were developed from a series of focus groups for the initial pilot project in conjunction with feedback from the health professionals facilitating the pilot project. Questionnaires were administered at enrolment (pre-test), at four weeks post intervention, and again at six months post intervention to glean longer term recall and risk behaviour change.During the final debriefing (session 4), VIP Program participants (intervention arm) completed a questionnaire assessing the immediate impact of the Program. This included process measures about adherence to the Program and completion of the workbook instructional activities, change in perceptions and attitudes regarding parenting and satisfaction with the Program, and the initial response to the virtual parenting experience and health behaviours during the Program.The pre-test and four-week post-test and six-month post-test questionnaires were completed by participants in the intervention and control arms of the study. The questionnaires included the following domains: participant demographics, life goals , current health behaviours  as well as readiness to change these behaviours; psychological distress as measured by the Kessler 10 ; knowledFor those students participating in the intervention trial arm of the study we retained the data that was recorded by the Infant Simulator during the care period. For each student there is a record of the amount of crying time, if the Infant Simulator was shaken badly or handled roughly or in the wrong position, the number of times the head fell back (not supported correctly), the nappy was changed, breastfed, burped and rocked. These records show whether the Infant Simulator had been well cared for or neglected.In addition to tracking a live birth outcome via data linkage, maternal and child health outcomes are being collected for study participants who give birth during the Trial period.Birth and early child health outcomes are obtained from the midwives data collection. Specifically, details regarding pregnancy complications, smoking status during pregnancy, plurality, gender, the child's birth weight, time to establish unassisted regular breathing, resuscitation method used (if applicable), Apgar scores at one and five minutes, estimated gestation, mode of separation (e.g. transferred or went home), adoption status, birth defects or birth trauma, any deaths of participants and still births are collected.Maternal health and wellbeing and child health is further assessed via a post-birth interview conducted at the participant's home six months after giving birth (first child only). A strict protocol is adhered to for contacting participants. The contact details of the participants are accessed though their birth records. To organise a home interview post birth, the research team first writes to the local child health nurse and requests that the nurse contact the participant seeking their consent for interview. Once that consent is given, an interviewer from the research team with child health qualifications contacts the participant to arrange the interview. The interviewer is 'blind' as to whether the participant is from the intervention or control arm of the study. The interviewer assesses: pre-conceptual health and risk behaviours, folate supplementation, injury prevention and immunisation awareness, postnatal depression  and psychological distress (K10); SIDS risk factor awareness; immunisation status; breastfeeding; awareness and uptake of health and other community supports; perceived level of support; and recall of specific VIP Program elements.The School Health Nurses were instrumental to the successful completion of the VIP Program in their school and their feedback on the Program content and delivery critical. On completion of Program implementation, each SHNs was interviewed by a member of the research team. The interview questionnaire included evaluation of the adequacy of VIP topics and resources, their perception of the Program impact, personal reactions to delivering the Program, and the impact of VIP on their professional relationship with the participants.The required sample size was calculated using a method that took into account the intra-cluster correlation coefficient, the anticipated effect size, the desired power, and the expected number of events. Utilising methods described by Schoenfeld and Richter  to calcuFor live births, the birth date of the baby will be used as the outcome date. For abortions, the recorded admission date for abortion will be used. For overall pregnancies we will estimate the due date of a pregnancy for abortion cases by adding 6 months to the abortion date, as the majority of induced abortions take place in the first trimester. Where more than one pregnancy outcome is detected, the date of the first event will be used. Kaplan-Meier survival analyses will be undertaken for these primary outcomes. To adjust for clustering by school and potential confounding variables, the data will be analysed using Cox proportional hazards regression, using the Lin and Wei robust sandwich estimate of the variance-covariance matrix. All analyses will be undertaken using SAS or SPSS.Ethical approval to approach students to participate in the trial and to consent to be tracked via data linkage up to the age of 20 years was obtained from the Princess Margaret Hospital (PMH) Ethics Committee. Furthermore, ethics approval has also been granted by the Confidentiality of Health Information Committee which specifically reviews study applications requiring data obtained via the Western Australian Data Linkage System (WADLS).The original Chief Investigators are authors SS, SB, BH, JC and DL who continue to steer the study. During the design, recruitment and implementation of the study authors SB, BH, JC and JS were employed within the Health Department of Western Australia or the Health Services in which the study was implemented. The study coordination team (SB and research coordinators and assistants) were physically based within the North Metropolitan Health Service during the recruitment and implementation phase. Once implementation was complete the study coordination moved into the Centre for Developmental Health, Curtin University and the Telethon Institute for Child Health Research. Primarily BH but also SB, JS and JC provided a crucial link between the study and the Health Service and Health Department Executive groups, in particular the North Metropolitan Health Service Population and Community Health Executive. The Population and Community Health Executive in each Health Service governed over school, child and community health workers in addition to Aboriginal health workers and Child Development Centres. The commitment from the North Metropolitan Health Service initially and then the East and South Metropolitan Health Services to evaluate the VIP Program has been integral and crucial to the governance of this trial.The study commenced in 2003 and is expected to be completed in late 2011 once all the participants reach 20 years of age.The few available reports on Infant Simulator based pre-conception interventions are limited to attitudes and beliefs around teenage pregnancy and knowledge and self reported use of contraception. The results of these studies are contradictory and limited by small sample sizes and study design. While research indicates that cognitive measures are associated with behavioural measures among young people, evidence concerning associations between these measures and teenage pregnancy is inconclusive ,44. FurtThis trial presents the first and only long term follow-up of pregnancy outcomes to evaluate an Infant Simulator based program. The authors are aware of only one other long term evaluation of an Infant Simulator based teen pregnancy prevention program where pregnancy outcomes have been tracked. While Hillman's thesis concluded that the BTIO intervention had been successful in delaying pregnancy by up to a year among its participants compared to a control group during a follow-up period of 3-5 years, her conclusions were based on a limited sample size of 221 students . In addiIn addition to this study being the first of its kind, it also has high generalisability  due to the wide coverage in public and (non catholic) private schools across the entire Perth metropolitan area providing variation in social and economic circumstances. The program has also been delivered by School Health Nurses, existing staff within the school, and participation by students was non-compulsory. Although this self-selection potentially creates participation bias for the Trial, it also represents the usual choice that is occurring for participation in such programs in schools. Furthermore, the VIP Program content has been developed according to best practice in health promotion delivery, and refined over a number of years. Results will therefore represent the impact of an Infant Simulator based program with optimal delivery. Internal validity of the study has been maximised by the use of uniform training of the School Health Nurses, utilisation of a Training Manual clearly outlining the process, and by pre-specified programming of the Infant Simulators in each of the schools. Furthermore, the scope of the data collected is comprehensive and the quality of data is high. It is estimated that the study will achieve over 95% coverage of live birth and induced abortion outcomes in the State via data linkage and direct approach to abortion clinics . While it is not possible to determine the number of cases lost to follow-up on the primary outcome, average migration rates from the state on an annual basis are low, less that 0.5% of the population .th and 8th graders in US schools from 78-80% in the intervention group and 67-72% in the control group [th graders (13-15 years old) [th or 12th graders (16-18 years old) [The main limitation to this Trial is the potential bias associated with low participation rates. The participation rates achieved by this Trial occurs in the broader context of declining participation rates in epidemiological studies over the past thirty years . Barrierol group . Elsewheol group . Only twars old)  and 60% ars old) . SeekingRecruitment bias becomes a threat to the external validity if there are systematic differences in the characteristics of participants in the intervention and control arms that are associated with the exposure or outcome variables. Unfortunately, the study was unable to collect information from the students who did not participate or the parents who failed to provide consent. Therefore we can only anticipate differences between participants and non-participants based on the best available evidence. In general epidemiological studies, participants are more likely to be of higher socioeconomic status, employed, married and of better health status. Further, in studies of risk behaviours, those engaged in those behaviours are less likely to participate  The requIn conclusion although the pragmatic nature of the trial and the low participation rates will provide some complexities for the analyses, the results will have international significance and advance the evidence to inform school based teen pregnancy prevention programs.VIP: Virtual Infant Parenting; IS: Infant Simulator; WA: Western Australia; TICHR: Telethon Institute for Child Health Research; ICC: Intra-class correlation; BTIO: Baby Think it Over; CONSORT: Consolidated Standards of Reporting Trials; WADLS: Western Australian Data Linkage System; HMDS: Hospital Morbidity Data System; SHN: School Health Nurse; GP: General Practitioner/DoctorThe authors declare that they have no competing interests.SS is the Principal Investigator for this research trial. SB, SS, JC and BH conceived the original study design. SB project managed the study, supervised research staff, enrolment and the follow-up of study participants. All authors have been involved with the ongoing steering and management of the research trial. All authors participated in the writing of this article, and read and approved the final version.