Managing Repetitive Behaviours: Clinical and cost effectiveness trial of a parent group intervention to manage restricted and repetitive behaviours in young children with ASD

Design (see flowchart): A randomised controlled trial of a parent group intervention to address challenging RRB in children with ASD, randomised to treatment (MRB©) or a psychoeducation parent group (current best practice). Baseline characteristics will be collected plus a range of primary and secondary outcome measures at baseline, end of group and follow-up (24 and 52wks) to capture both independent (blinded researcher), teacher and parent-reported changes. These include blinded ratings of improvement in child’s overall functioning (assessed using Clinical Global Impressions–Improvement (CGI-I)) and change in challenging RRB. Parent questionnaires will also provide information on child RRB, child participation and daily living skills, parent stress, self-efficacy, and impact on family life. Parents will be aware of group status but teachers and the primary outcome assessor will be blind to group allocation. Sample Size: We plan to approach approximately 325 families and expect to randomise 250 families (125 randomised to each arm). Assuming 5% type I error, 90% power, 10% intra-group correlation and equal allocation ratio, 224 families (an average of 8 families per parent group) are required to detect 20% improvement rate between the MRB intervention and parent psychoeducation group at 24 weeks. Health Technology: MRB involves eight weekly two hour parent group sessions, that focus on helping parents understand different types of RRB and identify potential developmental and environmental factors that may trigger and exacerbate challenging RRB for their child. Parents then learn to use a functional analytic approach, so strategies are tailored for each child, and to plan appropriate behavioural strategies to reduce challenging RRB. Inclusion criteria: Parents aged 18 years and over, child diagnosed with ASD aged 3-7 years with challenging RRB. Parents have sufficient spoken and written English to complete assessments and participate in the intervention. Exclusion criteria: Parent and child currently taking part in another parent group intervention. Parent with a current severe learning disability or a severe disabling mental illness. Sibling is taking part in the study. Measurement of costs and effectiveness: The economic evaluation will take the form of a within trial cost-effectiveness. Cost-utility and cost-consequence analyses and these will estimate the relative efficiency of the MRB intervention compared with psychoeducation at 52 weeks. The economic analysis will take the perspective of the NHS and personal social services but we will also take a wider perspective by including costs borne by the families (including, time lost from usual activities, travel time costs of accessing care). We will estimate the incremental costs per change in CGI-I and per QALY based on proxy scores from parents obtained using the CHU9D. Timetable: Recruitment, will take place over 18mths from three sites (4/5 families/site/month) a rate achieved in the pilot work, with study completion by 40mths, including one year follow-up assessments, data analysis, report write-up and dissemination. Team Expertise: The applicants have clinical, educational, voluntary, methodological and research expertise in ASD, together with expertise undertaking systematic reviews of outcome measures,and in developing and implementing clinical trials of complex intervention RCTs. The National Autistic Society has disseminated research and influenced UK policy.