Cognitive-behavioral treatment of persistent functional somatic complaints and pediatric anxiety: an initial controlled trial. Effectiveness of a quality improvement intervention for adolescent depression in primary care clinics: a randomized controlled trial. A child-focused intervention for coping with procedural pain: are parent and nurse coaches necessary? Parents as distraction coaches during i.v. insertion: a randomized study. Adolescent obesity intervention: validation of the SHAPEDOWN program. Nurse coaching and cartoon distraction: an effective and practical intervention to reduce child, parent, and nurse distress during immunizations. Art therapy as support for children with leukemia during painful procedures. A family-based randomized controlled trial of pain intervention for adolescents with sickle cell disease. Cognitive-behavioral intervention for distress in patients with melanoma: comparison with standard medical care and impact on quality of life. Treatment of posttraumatic stress symptoms in adolescent survivors of childhood cancer and their families: a randomized clinical trial. Clinical hypnosis versus cognitive behavioral training for pain management with pediatric cancer patients undergoing bone marrow aspirations. Age-related response to lidocaine-prilocaine (EMLA) emulsion and effect of music distraction on the pain of intravenous cannulation. Treatment of nonorganic recurrent abdominal pain: cognitive-behavioral family intervention. Randomized controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and adolescents with chronic pain. Blowing away shot pain: a technique for pain management during immunization. The quality of reporting of randomized controlled trials in solid organ transplantation. Targeted prevention of unipolar depressive disorder in an at-risk sample of high school adolescents: a randomized trial of a group cognitive intervention. Music therapy to reduce pain and anxiety in children with cancer undergoing lumbar puncture: a randomized clinical trial. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial.
Children and adolescents who seek medical treatment for persistent physical distress often suffer from co-occurring anxiety disorders. Treatment options for this impaired population are limited. This study tests the feasibility and potential efficacy of a cognitive-behavioral intervention targeting pain and anxiety for youth with impairing functional physical symptoms and anxiety disorders presenting to pediatricians for medical care.
                Children and adolescents (aged 8-16) experiencing somatic complaints, without an explanatory medical disorder (i.e., functional), were recruited from primary care and specialty (gastroenterologists and cardiologists) pediatricians. Forty children, primarily with gastrointestinal symptoms, who met criteria for a co-occurring anxiety disorder, were randomly assigned to a cognitive-behavioral treatment addressing pain and anxiety, Treatment of Anxiety and Physical Symptoms (TAPS), or to a waiting list control.
                TAPS was found to be an acceptable treatment for this population and was superior to the waiting list condition. Eighty percent of children in TAPS were rated as treatment responders by independent evaluators compared with none of the controls. Overall, self- and parent ratings indicated reductions in children's somatic discomfort and anxiety following intervention. TAPS participants maintained clinical gains 3 months following treatment.
                The study supports the feasibility and preliminary efficacy of a cognitive-behavioral intervention targeting co-occurring physical distress and anxiety in youth presenting for medical treatment. Such an approach has the potential to exert broad impact on children's dysfunction and to minimize exposure to invasive, ineffective, and costly medical procedures and treatments.
                © 2011 Wiley-Liss, Inc. Depression is a common condition associated with significant morbidity in adolescents. Few depressed adolescents receive effective treatment for depression in primary care settings.
                To evaluate the effectiveness of a quality improvement intervention aimed at increasing access to evidence-based treatments for depression (particularly cognitive-behavior therapy and antidepressant medication), relative to usual care, among adolescents in primary care practices.
                Randomized controlled trial conducted between 1999 and 2003 enrolling 418 primary care patients with current depressive symptoms, aged 13 through 21 years, from 5 health care organizations purposively selected to include managed care, public sector, and academic medical center clinics in the United States.
                Usual care (n = 207) or 6-month quality improvement intervention (n = 211) including expert leader teams at each site, care managers who supported primary care clinicians in evaluating and managing patients' depression, training for care managers in manualized cognitive-behavior therapy for depression, and patient and clinician choice regarding treatment modality. Participating clinicians also received education regarding depression evaluation, management, and pharmacological and psychosocial treatment.
                Depressive symptoms assessed by Center for Epidemiological Studies-Depression Scale (CES-D) score. Secondary outcomes were mental health-related quality of life assessed by Mental Health Summary Score (MCS-12) and satisfaction with mental health care assessed using a 5-point scale.
                Six months after baseline assessments, intervention patients, compared with usual care patients, reported significantly fewer depressive symptoms (mean [SD] CES-D scores, 19.0 [11.9] vs 21.4 [13.1]; P = .02), higher mental health-related quality of life (mean [SD] MCS-12 scores, 44.6 [11.3] vs 42.8 [12.9]; P = .03), and greater satisfaction with mental health care (mean [SD] scores, 3.8 [0.9] vs 3.5 [1.0]; P = .004). Intervention patients also reported significantly higher rates of mental health care (32.1% vs 17.2%, P<.001) and psychotherapy or counseling (32.0% vs 21.2%, P = .007).
                A 6-month quality improvement intervention aimed at improving access to evidence-based depression treatments through primary care was significantly more effective than usual care for depressed adolescents from diverse primary care practices. The greater uptake of counseling vs medication under the intervention reinforces the importance of practice interventions that include resources to enable evidence-based psychotherapy for depressed adolescents. To examine the efficacy of training children to cope with immunization pain without the assistance of trained coaches and determine whether untrained parents or nurses are more effective at decreasing children's distress.
                We compared the procedural coping and distress behavior of 31 3- to 7-year-old children trained in coping skills to 30 who did not receive training. The behavior of the untrained parents and nurses was evaluated as it related to child coping and distress.
                Children demonstrated understanding of the training, but they did not use the coping skills during the procedure. In general, the nurses' behavior was associated with child coping and parents' behavior with child distress.
                More extensive child training or the involvement of coaches for procedural distress might be necessary. Nurses' behavior appears to center on encouraging child coping, and parents tend to comfort child distress. This study investigated the effectiveness of a brief Distraction Education intervention for parents prior to their preschool children's medical procedures. Forty-four preschool children with chronic non-life-threatening conditions were having intravenous catheters (IVs) placed for medical tests. Parent-child dyads were randomized into two groups. The experimental group received Distraction Education prior to IV insertion; the control group received standard care. Data were analyzed for two phases of the IV procedure. Phase 1 was the preparation for needle insertion; Phase 2 began with needle insertion. Experimental group parents used significantly more distraction than did control group parents during both phases (P < 0.001). There were no group differences for child behavioral distress or self-report of pain. There was a trend toward a group by phase interaction for behavioral distress (P = 0.07); more experimental group children showed decreased behavioral distress over time (from phase 1 to phase 2) than did control group children (P = 0.02). The effectiveness of the adolescent obesity intervention SHAPEDOWN was evaluated for 15 months through a randomized experimental design study. Test groups (no. = 37) participating in the intervention were compared with a no-treatment control group (no. = 29) at four sites in northern California. The program employs a variety of cognitive, behavioral, and affective techniques adapted to make successive small modifications in diet, exercise, communication, and affect that are sustainable. Very-low-calorie or restrictive diets are avoided in the program. Parents are instructed on strategies for supporting their adolescents' weight-loss efforts. Participation in the group application of the program was associated with significant improvement in relative weight, weight-related behavior, depression, and knowledge of weight management concepts at post-treatment and at 1-year follow-up. Self-esteem increased significantly regardless of condition. Change in relative weight for the test group was -9.9 +/- 14.9% (mean +/- standard deviation) and for the control group was -0.10 +/- 13.2%. At month 15 of the study period, weight change in the test group compared with the controls was -5.15 kg. For all subject variables examined in the test group, mean change in relative weight at 1-year follow-up was negative, suggesting that none of the characteristics examined contraindicate program participation among obese adolescents seeking care. Drop-out rate was 16%. The study suggests that the program produces significant long-term outcomes in obese adolescents and is transferable to a variety of settings. Evaluated a low cost and practical intervention designed to decrease children's, parents', and nurses' distress during children's immunizations. The intervention consisted of children viewing a popular cartoon movie and being coached by nurses and parents to attend to the movie. Ninety-two children, 4-6 years of age, and their parents were alternatively assigned to either a nurse coach intervention, a nurse coach plus train parent and child intervention, or a standard medical care condition. Based on previous findings of generalization of adult behaviors during medical procedures, it was hypothesized that training only the nurses to coach the children would cost-effectively reduce all participants levels of distress. Observational measures and subjective ratings were used to assess the following dependent variables: children's coping, distress, pain, and need for restraint; nurses' and parents' coaching behavior; and parents' and nurses' distress. Results indicate that, in the two intervention conditions, children coped more and were less distressed, nurses and parents exhibited more coping promoting behavior and less distress promoting behavior, and parents and nurses were less distressed than in the control condition. Although neither intervention was superior on any of the variables assessed in the study, nurse coach was markedly more practical and cost-effective. Therefore, nurses' coaching of children to watch cartoon movies has great potential for dissemination in pediatric settings. Children with leukemia undergo painful procedures such as lumbar puncture and bone marrow aspiration. To overcome pain, certain units offer total anesthesia; others offer generic support; others offer no preparation at all. Since September, 1997, we have provided leukemic children with art therapy (AT), a nonverbal and creative modality that develops coping skills. Our goal is to prevent anxiety and fear during painful interventions as well as prolonged emotional distress.
                We treated 32 children aged 2-14 years. The modes of AT before, during, and after the punctures were as follows: clinical dialogue to calm children and help them cope with painful procedures; visual imagination to activate alternative thought processes and decrease the attention towards overwhelming reality and raise the peripheral sensitivity gate; medical play to clarify illness, eliminate doubts, and offer control over threatening reality; structured drawing to contain anxiety by offering a structured, predictable reality (the drawing) that was controllable by children; free drawing to allow children to externalize confusion and fears; and dramatization to help children accept and reconcile themselves to body changes.
                Children hospitalized before September, 1997, exhibited resistance and anxiety during and after painful procedures. By contrast, children provided with AT from the first hospitalization exhibited collaborative behavior. They or their parents asked for AT when the intervention had to be repeated. Parents declared themselves better able to manage the painful procedures when AT was offered.
                AT was shown to be a useful intervention that can prevent permanent trauma and support children and parents during intrusive interventions.
                Copyright 2001 Wiley-Liss, Inc. The study had 2 aims---to determine the efficacy of a family-based cognitive-behavioral pain management intervention for adolescents with sickle cell disease (SCD) in (1) reducing pain and improving health-related variables and (2) improving psychosocial outcomes. Each adolescent and a family support person were randomly assigned to receive a brief pain intervention (PAIN) (n=27) or a disease education attention control intervention (DISEASE ED) (n=26) delivered at home. Assessment of primary pain and health-related variables (health service use, pain coping, pain-related hindrance of goals) and secondary psychosocial outcomes (disease knowledge, disease self-efficacy, and family communication) occurred at baseline (before randomization), postintervention, and 1-year follow-up. Change on outcomes did not differ significantly by group at either time point. When groups were combined in exploratory analyses, there was evidence of small to medium effects of intervention on health-related and psychosocial variables. Efforts to address barriers to participation and improve feasibility of psychosocial interventions for pediatric SCD are critical to advancing development of effective treatments for pain. Sample size was insufficient to adequately test efficacy, and analyses did not support this focused cognitive-behavioral pain management intervention in this sample of adolescents with SCD. Exploratory analyses suggest that comprehensive interventions, that address a broad range of skills related to disease management and adolescent health concerns, may be more effective in supporting teens during healthcare transition. Melanoma accounts for > 79% of skin cancer-related deaths, although it accounts for only 4% of skin cancer incidence. Given the potential for lethality, it is likely that patients with melanoma may experience significant emotional distress. The current study was designed to determine the effect of a cognitive-behavioral intervention on distress and health-related quality of life (HRQOL) in patients with melanoma who had medium-to-high distress.
                Forty-eight patients who had Global Severity Index scores >or= 60 2 months after their initial visit to the multidisciplinary melanoma clinic were randomized to receive either standard care or 4 sessions of a cognitive-behavioral intervention (CBI). Repeated assessments using the Brief Symptom Inventory, the Medical Outcomes Survey Short Form-36, and the State-Trait Anxiety Inventory occurred at baseline, at 2 months, and at 6 months after intervention for both groups.
                An intent-to-treat analysis did not reveal significantly lower distress in the CBI group at 2 months or 6 months of follow-up, although differences were noted in anxiety and HRQOL. An effect-of-intervention analysis did reveal lower levels of distress in the CBI group at 2 months, with differences approaching significance at 6 months.
                The four-session CBI significantly reduced distress and improved HRQOL for a period of 2 months in patients with melanoma who had medium-to-high distress, with improved general health evident 6 months after the intervention. Some variation in results was revealed in an intent-to-treat analysis. The initial evidence from the current study showed that a brief intervention may be effective for creating change in individuals with cancer who have increased distress, although further research is needed to identify the most optimal approach for delivering the intervention.
                Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11579 Posttraumatic stress symptoms (PTSS), particularly intrusive thoughts, avoidance, and arousal, are among the most common psychological aftereffects of childhood cancer for survivors and their mothers and fathers. We conducted a randomized wait-list control trial of a newly developed 4-session, 1-day intervention aimed at reducing PTSS that integrates cognitive-behavioral and family therapy approaches--the Surviving Cancer Competently Intervention Program (SCCIP). Participants were 150 adolescent survivors and their mothers, fathers, and adolescent siblings. Significant reductions in intrusive thoughts among fathers and in arousal among survivors were found in the treatment group. A multiple imputations approach was used to address nonrandom missing data and indicated that treatment effects would likely have been stronger had more distressed families been retained. The data are supportive of brief interventions to reduce PTSS in this population and provide additional support for the importance of intervention for multiple members of the family.
                Copyright 2004 American Psychological Association A randomized controlled trial was conducted to compare the efficacy of clinical hypnosis versus cognitive behavioral (CB) coping skills training in alleviating the pain and distress of 30 pediatric cancer patients (age 5 to 15 years) undergoing bone marrow aspirations. Patients were randomized to one of three groups: hypnosis, a package of CB coping skills, and no intervention. Patients who received either hypnosis or CB reported less pain and pain-related anxiety than did control patients and less pain and anxiety than at their own baseline. Hypnosis and CB were similarly effective in the relief of pain. Results also indicated that children reported more anxiety and exhibited more behavioral distress in the CB group than in the hypnosis group. It is concluded that hypnosis and CB coping skills are effective in preparing pediatric oncology patients for bone marrow aspiration. To compare the efficacy of a local anesthetic cream and music distraction in reducing or preventing pain from needle puncture (intravenous cannulation) in children. A secondary aim was to examine the influence of age on the pain report and behavior and on the therapeutic outcome.
                Children aged 4 to 16 years (N = 180) who were to undergo surgery under general anesthesia via intravenous cannulation were randomly allocated to one of three interventions. The comparison of lidocaine-prilocaine emulsion (EMLA, Astra) and a placebo emulsion was double-blind. Stratification by age group (4 to 6, 7 to 11, 12 to 16) ensured an equal number of children (20) in each intervention/age group category. A global assessment of the behavioral reaction to the procedure was made by the principal investigator, taking into account vocal, verbal, facial, and motor responses. The child was asked to assess pain severity on the Faces Pain Scale (FPS) and a visual analogue toy (VAT). The scales were applied conservatively as ordinal scales: FPS 0 to 6; VAT 0 to 10.
                Children who received lidocaine-prilocaine emulsion reported less pain (mean FPS score = 1.42) compared with placebo emulsion (mean FPS score = 2.58) and with music distraction (mean FPS = 2.62). There was a highly significant therapeutic effect (P < .001) on the self-report and behavioral scores. Younger children, regardless of intervention, reported significantly more pain than the older children (mean FPS scores: 2.85, 2.33, 1.43 for age groups 4 to 6, 7 to 11, and 12 to 16 respectively; P < .001). The superiority of the local anesthetic emulsion was maximal in the youngest age group (4 to 6) almost eliminating pain-related behavior, and multiple regression analysis confirmed significant age and treatment effects and revealed interaction between therapeutic effect and age. Although a trend favoring the active emulsion was evident in the older children (7 to 11, 12 to 16) the differences were not significant. The pain scores were influenced by the type (gauge) of cannula, but this did not affect the conclusion regarding therapeutic and age effects. There was no influence of sex, experience with venipuncture, or whether the child was anxious on arrival in the operating room.
                The results show that lidocaine-prilocaine emulsion is highly effective in preventing pain from venipunctures in young children, the group in most need of prevention. We evaluated the efficacy of cognitive-behavioral family intervention in the treatment of crises of pain in children with nonorganic recurrent abdominal pain (RAP) and the thresholds of pain for 17 body surface areas in these children.
                A randomized clinical trial was undertaken with 32 children between the ages of 5.1 and 13.9 years with nonorganic RAP. A group of 15 patients, aged 9.9 +/- 2.2 years (11 girls), received standard pediatric care and cognitive-behavioral family intervention for treatment of pain crises. The control group of 17 children, aged 8.4 +/- 2.0 years (11 girls), received only standard pediatric care. These procedures were undertaken by general pediatricians over 4 monthly sessions. An analog visual scale was used to measure the frequency and intensity of the pain crises per month and a mechanical pressure algometer for the measurement of pain threshold.
                The median frequency of pain crises per month reported by patients at the 3 monthly cognitive-behavioral family intervention sessions was 15, 5, 2 and 2, respectively. In contrast, the median frequency for pain crises per month reported by the control group was 12, 8, 10 and 8, respectively. The difference between the intervention group and the controls was statistically significant for frequency of pain at the second, third and fourth visits. There was no statistical difference for intensity of pain or for measured pain thresholds between the control and the intervention group.
                The cognitive-behavioral family intervention reduced the frequency of pain crises of children with nonorganic RAP. This successful intervention was carried out by the intervention of general pediatricians. Cognitive-behavioral therapy (CBT) interventions show promise for decreasing chronic pain in youth. However, the availability of CBT is limited by many factors including distance to major treatment centers and expense. This study evaluates a more accessible treatment approach for chronic pediatric pain using an Internet-delivered family CBT intervention. Participants included 48 children, aged 11-17 years, with chronic headache, abdominal, or musculoskeletal pain and associated functional disability, and their parents. Children were randomly assigned to a wait-list control group or an Internet treatment group. Primary treatment outcomes were pain intensity ratings (0-10 NRS) and activity limitations on the Child Activity Limitations Interview, both completed via an online daily diary. In addition to their medical care, the Internet treatment group completed 8 weeks of online modules including relaxation training, cognitive strategies, parent operant techniques, communication strategies, and sleep and activity interventions. Youth randomized to the wait-list control group continued with the current medical care only. Findings demonstrated significantly greater reduction in activity limitations and pain intensity at post-treatment for the Internet treatment group and these effects were maintained at the three-month follow-up. Rate of clinically significant improvement in pain was also greater for the Internet treatment group than for the wait-list control group. There were no significant group differences in parental protectiveness or child depressive symptoms post-treatment. Internet treatment was rated as acceptable by all children and parents. Findings support the efficacy and acceptability of Internet delivery of family CBT for reducing pain and improving function among children and adolescents with chronic pain. To study the effect of an active distraction technique on pain in preschool children receiving diphtheria, pertussis, and tetanus immunization.
                Randomized, unblinded controlled study.
                Columbus Public Health Department Immunization Clinics.
                One hundred forty-nine 4- to 7-year-old children.
                Children were taught to blow out air repeatedly during the injection, as if they were blowing bubbles.
                Children who were taught to blow out air during their shots had significantly fewer pain behaviors (P < .04) and demonstrated a trend toward lower subjectively reported pain (P = .06). There was no significant difference in the nurse or parent visual analog scale scores.
                A simple distraction technique can be effective in helping children cope with the pain of immunization. The use of such a technique to relieve the pain and distress associated with even a brief painful procedure should be encouraged. Randomized controlled trials (RCTs) of interventions provide the highest level of evidence about efficacy but their value either alone or within a meta-analysis is dependent on its methodological quality. For this reason recent RCTs in organ transplantation were assessed for quality. RCTs published between 2004 and 2006 (n = 332) were assessed, after excluding duplicate and nonEnglish reports. Quality was evaluated using the Jadad score plus allocation concealment and intention to treat analysis. We noted journal type, journal author instructions, funding source, sample size and number and location of study centres. Around one-third of RCTs had a Jadad score of 3 or greater (indication of a methodologically good quality trial) and the other two parameters were satisfied in just over one third. Although the majority of trials were published in speciality journals the quality of those published in general journals was superior. Commercially sponsored trials were of better quality as were multicentre trials in contrast to single centre trials. Overall quality of reporting of RCTs in organ transplantation is poor and as RCTs provide the highest level of evidence in evaluations of interventions there needs to be a concerted effort within the transplant community to improve the standards of RCTs. This investigation attempted to prevent unipolar depressive episodes in a sample of high school adolescents with an elevated risk of depressive disorder.
                Adolescents at risk for future depressive disorder by virtue of having elevated depressive symptomatology were selected with a two-stage case-finding procedure. The Center for Epidemiologic Studies-Depression Scale (CES-D) was administered to 1,652 students; adolescents with elevated CES-D scores were interviewed with the Schedule for Affective Disorders and Schizophrenia for School-Age Children. Subjects with current affective diagnoses were referred to nonexperimental services. The remaining 150 consenting subjects were considered at risk for future depression and randomized to either a 15-session cognitive group prevention intervention or an "usual care" control condition. Subjects were reassessed for DSM-III-R diagnostic status after the intervention and at 6- and 12-month follow-up points.
                Survival analyses indicated a significant 12-month advantage for the prevention program, with affective disorder total incidence rates of 14.5% for the active intervention, versus 25.7% for the control condition. No differences were detected for nonaffective disorders across the study period.
                Depressive disorder can be successfully prevented among adolescents with an elevated future risk. A nonpharmacological method can be an alternative or complement to analgesics.The aim of this study was to evaluate if music medicine influences pain and anxiety in children undergoing lumbar punctures. A randomized clinical trial was used in 40 children (aged 7-12 years) with leukemia, followed by interviews in 20 of these participants. The participants were randomly assigned to a music group (n = 20) or control group (n = 20). The primary outcome was pain scores and the secondary was heart rate, blood pressure, respiratory rate, and oxygen saturation measured before, during, and after the procedure. Anxiety scores were measured before and after the procedure. Interviews with open-ended questions were conducted in conjunction with the completed procedures. The results showed lower pain scores and heart and respiratory rates in the music group during and after the lumbar puncture. The anxiety scores were lower in the music group both before and after the procedure. The findings from the interviews confirmed the quantity results through descriptions of a positive experience by the children, including less pain and fear. This study evaluated the effectiveness (changes in health behaviors, health status, and health service utilization) of a self-management program for chronic disease designed for use with a heterogeneous group of chronic disease patients. It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities.
                The study was a six-month randomized, controlled trial at community-based sites comparing treatment subjects with wait-list control subjects. Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease, lung disease, stroke, or arthritis. Health behaviors, health status, and health service utilization, as determined by mailed, self-administered questionnaires, were measured.
                Treatment subjects, when compared with control subjects, demonstrated improvements at 6 months in weekly minutes of exercise, frequency of cognitive symptom management, communication with physicians, self-reported health, health distress, fatigue, disability, and social/role activities limitations. They also had fewer hospitalizations and days in the hospital. No differences were found in pain/physical discomfort, shortness of breath, or psychological well-being.
                An intervention designed specifically to meet the needs of a heterogeneous group of chronic disease patients, including those with comorbid conditions, was feasible and beneficial beyond usual care in terms of improved health behaviors and health status. It also resulted in fewer hospitalizations and days of hospitalization.
Overall, there is preliminary evidence that a variety of cognitive-behavioral interventions can be used with children and adolescents to successfully manage or reduce pain and distress associated with needle-related procedures. However, many of the included studies received lower quality scores because they failed to describe the randomization procedure and participant withdrawals or drop-outs from the study. Further RCTs need to be conducted, particularly for the many interventions for which we could not locate any trials.