Title: A randomised controlled cluster trial comparing the effectiveness and cost effectiveness of a school based cognitive behaviour therapy programme (FRIENDS) in the reduction of anxiety and improvement in mood in children aged 9/10
Funder: Department of Health (England)

Abstract: DESIGN: Randomised controlled cluster trial comparing FRIENDS (delivered by health professional or school) vs. treatment as usual for the reduction and prevention of anxiety symptoms and low mood (i.e. reduced symptoms of depression) in children aged 9/10. SETTING: 45-54 junior schools in Bath and North East Somerset and Wiltshire. INTERVENTION BEING EVALUATED: FRIENDS is a manualised cognitive behaviour therapy (CBT) programme designed to improve childrens mental health. Each child has a workbook and group leaders a comprehensive manual detailing the content and structure of each session. FRIENDS involves 10 60-minute weekly sessions delivered to whole classes as part of the school PSHE programme. FRIENDS teaches children practical skills to identify their feelings; to learn to relax; to identify unhelpful thoughts and to replace them with more helpful thoughts; and how to face and overcome their problems and challenges. Initial training and regular supervision of leaders will be provided by a specialist CBT expert. An additional session for parents/carers is provided at the start of FRIENDS to provide an overview of the programme the CBT rationale and the skills the children will be taught. Parents will receive a sheet at the end of each session summarising what the children have discussed and the ideas they will be practicing each week so that they can reinforce and encourage their use at home. MEASUREMENT OF OUTCOMES AND DURATION OF FOLLOW-UP: (a). Psychological functioning: The primary outcomes will be reduced levels of anxiety and improved mood (i.e. reduced symptoms of depression) as assessed on continuous measures at 6 & 12 months. Secondary outcomes are improved self-esteem and reductions in bullying. Assessments at 3 different times: •Time 1 baseline; •Time 2 post FRIENDS (6 months); •Time 3 12 month. Parents will complete a behavioural screening questionnaire at all 3 time points. (b). Acceptability: Children will rate FRIENDS on 10 dimensions e.g. enjoyment acquisition and use of new skills etc. (c). Delivery: Leaders will assess FRIENDS on factors such as child engagement school support etc. (d). Treatment fidelity will be assessed by observing a random selection of 10% of FRIENDS sessions and assessing whether learning points and exercises were covered. (e). Parent Interviews at baseline and 6 months: For the economic evaluation a purposeful sample of carers/parents of 300 children 100 from each condition will complete the Client Receipt of Services Questionnaire about their child’s use of health social and educational services. Qualitative interviews with 20 parents from the FRIENDS group to assess how and why the intervention might benefit children e.g. changes in friendships; family relationships; educational progress and engagement in out of school social and recreational activity. (f). Cost and cost-effectiveness: an analysis comparing the two versions of FRIENDS vs. treatment as usual. The cost-effectiveness analysis will be based on the primary outcome measures. Both the cost analysis and the cost-effectiveness analysis will be from the joint perspective of the health (NHS) and education/social services sector. The research will identify measure and value the resource consequences of each alternative (applying opportunity cost as the main principle for valuation. PLANNED ANALYSIS: Analysis and presentation of data will be in accordance with CONSORT guidelines. The primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals for the between-arm comparisons. Descriptive student- and class-level statistics will be used to ascertain any marked imbalance between the arms at baseline. The primary analysis will employ a mixed effect linear regression model to compare the active CBT interventions versus treatment as usual adjusting for stratification variables and baseline score and taking appropriate account of the hierarchical nature of the data (repeated measures students classes and schools). Sensitivity analyses making different assumptions will be conducted to investigate the potential effects of missing data. Secondary analyses will include: 1) repeating the primary analysis adjusting for any variables exhibiting marked imbalance at baseline to examine whether this influences the findings; 2) comparison of children who score high and low on anxiety and mood questionnaires at baseline to examine who most benefits form these interventions; 3) similar analyses for other secondary outcomes (using appropriate multi-level models and adjusting p-values for multiple testing); 4) investigation of process measures such as number of sessions attended. PROJECT TIMETABLE: Mth 1-2: Recruitment establish project infra-structure. Mth 3-6: School recruitment; recruit FRIENDS leaders. Mth 7-8; Randomisation; prepare assessments. Mth 9; Training; consent. Mth 10-12: Baseline assessments; deliver interventions.Mth 13-15: data entry cleaning and checking. Mth 16-18: Baseline analysis & 6 month assessments. Mth 19-21: 6 month data entry cleaning and checking. Mth 22-24: analysis and 12 month follow-up. Mth 25-27: 12 month data entry cleaning and checking. Mth 28-30: analysis. Mth 31-36: Project write up and dissemination. RECRUITMENT RATES: Local pilot work in 30 junior schools indicates that less than 1% of children opt out of FRIENDS and that approximately 90% complete baseline and follow-up assessments. Conservatively we predict 90% of the eligible population will participate and of these 80% will complete follow-ups.


Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: MENTAL HEALTH