A non-inferiority randomised controlled trial comparing the clinical and cost-effectiveness of one session treatment (OST) with multi-session cognitive behavioural therapy (CBT) in children with specific phobias

Background. One-session treatment (OST) combines multiple approaches within a single session and has been found to be effective for the treatment of specific phobias in adults. Whether this less resource intensive treatment can be as effective as CBT in children is of considerable importance in informing health services on best policy and practice. Aim: To examine the non-inferiority of OST as compared with multi-session CBT. If this condition is satisfied, then the superiority of OST over CBT could be assessed by examining cost effectiveness. Design: A multicentre pragmatic non-inferiority RCT comparing OST to multi-session CBT, with a 9-month internal pilot. Stop/Go criteria will be based on the feasibility of recruitment, retention and safety outcomes. A stopping criterion of 75% (n=102) of the recruitment target at 9 months and 70% (n=32) of outcome measures will be set. A DMEC will review the data at the end of the pilot and periodically throughout the trial for safety. Allocation to groups will be conducted remotely through Sheffield CTRU. We will ask participants their treatment preferences at baseline to examine the impact of patient preference in the analysis. Setting: Recruitment through schools, primary care, child mental health and IAPT services in locations across the North of England, Sheffield, York, Leeds and Norfolk. Target population: Children aged 7-16 years, with a specific phobia that impacts on their daily functioning as measured by the CAIS-P. Health technology assessed: OST is a combination of treatment techniques intensified into a single 3 hour session. This method combines graduated exposure therapy, participant modelling, reinforcement, psychoeducation, cognitive challenges, and skills training. Measurement of outcomes: The primary outcome measure will be patient scores on the Behavioural Approach Test (BAT) conducted by an independent observer blind to allocation, 6 months after trial entry. The primary outcome and secondary outcome measures listed below will be assessed at baseline and 6 months. 1. Clinical severity rating using the ADIS–C (Silverman & Albano, 1996). 2. The Fear Survey Schedule for Children—Revised (FSSC-R; Ollendick, 1983) 3. A goal based outcome measure 3. The EQ-5DY. 4. REQoL 4. Child Anxiety Impact Scale (CAIS-P/C) (Langley et al, 2004) 5. Custom designed resource use questionnaires Sample size: We need to recruit 143 participants per group (286 in total). This gives 90% power with 5% statistical significance for a range of equivalence of 0.4, assuming attrition of 20% and therapist effects (ICC=0.01) . The range of equivalence is based on the meta-analysis conducted by Reynolds (2010). Data analysis: The statistical analysis will be performed on those who complete the intervention and reported according to CONSORT guidelines. The primary outcome, the mean BAT score at 6 months, will be compared between groups using an ANCOVA analysis to compare the groups controlling for baseline scores. We will undertake a cost-effectiveness analysis at the end of the trial by comparing the cost of the intervention to any treatment benefit. A long-term analysis to project the impact of the treatments on quality of life over a longer period will also be conducted. Project timetable: 48 months: study set-up (10 months); school screening (2 months); total recruitment (24 months); follow up (6 months), closedown, analysis and write-up (6 months)