Research Review: Recommendations for reporting on treatment trials for child and adolescent anxiety disorders - an international consensus statement.

BACKGROUND: Anxiety disorders in children and young people are common and bring significant personal and societal costs. Over the last two decades, there has been a substantial increase in research evaluating psychological and pharmacological treatments for anxiety disorders in children and young people and exciting and novel research has continued as the field strives to improve efficacy and effectiveness, and accessibility of interventions. This increase in research brings potential to draw together data across studies to compare treatment approaches and advance understanding of what works, how, and for whom. There are challenges to these efforts due largely to variation in studies' outcome measures and variation in the way study characteristics are reported, making it difficult to compare and/or combine studies, and this is likely to lead to faulty conclusions. Studies particularly vary in their reliance on child, parent, and/or assessor-based ratings across a range of outcomes, including remission of anxiety diagnosis, symptom reduction, and other domains of functioning (e.g., family relationships, peer relationships). METHODS: To address these challenges, we convened a series of international activities that brought together the views of key stakeholders (i.e., researchers, mental health professionals, young people, parents/caregivers) to develop recommendations for outcome measurement to be used in treatment trials for anxiety disorders in children and young people. RESULTS AND CONCLUSIONS: This article reports the results of these activities and offers recommendations for selection and reporting of outcome measures to (a) guide future research and (b) improve communication of what has been measured and reported. We offer these recommendations to promote international consistency in trial reporting and to enable the field to take full advantage of the great opportunities that come from data sharing going forward.

Feasibility Study of Back2School, a Modular Cognitive Behavioral Intervention for Youth With School Attendance Problems.

There is large heterogeneity among youth with school attendance problems (SAPs). For this reason, protocols for the treatment of SAPs need to be flexible. Back2School (B2S) is a new manual-based, modular transdiagnostic cognitive behavioral intervention to increase school attendance among youth with SAPs. It also aims to increase the self-efficacy of these youth and their parents. B2S includes evidence-based modules addressing youth anxiety, depression, and behavior problems, together with modules focused on parent guidance and school consultation. The current study examined the feasibility of evaluating B2S in an randomized controlled trial and acceptability of the B2S program in a non-randomized trial, including both qualitative and quantitative data, in preparation for a randomized controlled trial of its effectiveness. Youth, parents, and teachers completed questionnaires at baseline, post-intervention, and follow-up. School attendance data were collected from school registers. Twenty-four youth with a SAP (defined as more than 10% absenteeism during the last 3 months) were recruited from primary and lower secondary schools in Aarhus Municipality, Denmark. Their parents also participated in B2S. Two of the 24 families withdrew during the intervention, after sessions two and six respectively. Of the remaining 22 families, 19 (86%) completed all 10 sessions. Parents and youth rated their satisfaction with B2S as high, and high levels of satisfaction were maintained 1 year after the intervention. Teacher satisfaction was lower than that of youth and parents, but the majority found the school's participation in the intervention helpful. Preliminary evaluation of intervention outcomes showed significant increase in school attendance and decrease in psychological symptoms, as well as a significant increase in self-efficacy for both youth and parents. Based on this feasibility data, adaptations were made to the B2S manual and study procedures prior to commencement of a randomized controlled effectiveness trial. The main adaptation to the manual was to increase school consultation. The main procedural adaptation was to broaden recruitment. Furthermore, it was necessary to increase level of staffing by psychologists because treatment delivery was more time consuming than expected.

The efficacy of manualized Cognitive Behavior Therapy conducted by student-therapists treating Danish youths with anxiety using a benchmark comparison.

BACKGROUND: Several systematic reviews have demonstrated the efficacy of cognitive behavioral therapy (CBT) treating anxiety disorders in children and adolescents (hereafter referred to as youths). Treatment of anxiety disorders conducted by student therapists (ST) has been found to be an effective alternative, to treatment conducted by psychologists. OBJECTIVE: The primary aim of the study is to investigate the effects of ST treating youths, using a group-based CBT program. Second, the study aims to compare these results with outcomes achieved by professional-therapists (PT). METHOD: The study investigate in an open trial design, the treatment outcome from a manualized CBT program (Cool Kids) in a group of youths (n = 54) treated by ST. Results are benchmarked against the outcomes of a group of youths (n = 56) treated by PT using the same program, derived from a separate randomized controlled trial. RESULTS: There was a significant reduction of both self-reported and clinician rated measures of youth anxiety over time in the ST group, with small to large effect sizes. No significant differences of improvements in self-report measures were found between the ST and the PT groups. There was no significant difference in remission rates for participants' primary anxiety disorder between the ST (50.0%) and the PT (66.1%) at post-treatment or at three-month follow-up (ST: 74.1%, PT: 76.8%). There was a significant difference regarding number of youths free of all anxiety disorder between the ST (14 [25.9%]) and PT (27 [48.2%]) group at post-treatment. This difference was not significant at three-month follow-up (ST: 25 [46.3%], PT: 33 [58.9%]). CONCLUSION: The findings support previous findings, suggesting that student-therapists, receiving training and supervision, can successfully treat youths with anxiety disorders using a manualized CBT program. The outcomes following CBT treatment conducted by ST are comparable to outcomes achieved by PT.

The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial.

BACKGROUND: School absenteeism (SA) is associated with anxiety, depression, and disruptive behavior. It is a risk factor for academic difficulties and school dropout, which predict problems in adulthood such as social, work-related, and health problems. The main goal of this study is to examine the initial effectiveness of a modular transdiagnostic cognitive behavioral therapy (CBT) intervention (Back2School) for increasing school attendance and decreasing psychological problems, relative to a comparator control arm (treatment as usual [TAU]). METHODS/DESIGN: One hundred sixty children, aged 7 to 16 years, will be randomly assigned to either Back2School or TAU. The design is a two (Back2School and TAU) by four (preassessment [T1], postassessment [T2], and 3-month [T3] and 1-year [T4] assessments) mixed between-within design. The primary outcome is school attendance based on daily registration. Secondary outcomes pertain to youth psychosocial functioning, quality of life, bullying, self-efficacy, and teacher-parent collaboration. These secondary outcomes are measured via youth, parent, and teacher reports. DISCUSSION: This study will provide critically needed empirical evidence on the initial effectiveness of a manualized treatment program for youth with SA. If the intervention is found to be effective, the program can be further implemented and tested in a larger school health effectiveness trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03459677 . Retrospectively registered on 9 March 2018.