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

Abstract: 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.

Lay abstract: Challenging restricted repetitive behaviours (RRB) such as repetitive movements, routines, restricted interests, and resistance to change can interfere with an autistic child’s ability to engage in everyday living activities, reduce social opportunities and prevent learning new skills [10]. These types of RRB are stigmatizing and associated with self-injurious behaviours and aggression to others [11,12]. The disruptive impact of RRB can in turn provoke negative parenting styles, especially when parents are not able to access appropriate support [13]. Research suggests early intervention for young children with ASD can have a positive impact on language and cognitive development [6]. However, most ASD early interventions focus on social communication. There are no evaluated specific early interventions for RRB [4]. Parents report they need strategies and advice on how to manage their child’s challenging RRB [19]. Design: Parents will be randomly allocated to receive the Managing Repetitive Behaviours (MRB) intervention or parent psychoeducation sessions (equivalent to current best practice) which will provide families the same number of opportunities for discussion and sharing of ideas but without any specific information about the function of RRB and tailored strategies. The effectiveness of this intervention will be assessed by measuring whether: (i) children show overall improvement in functioning after the MRB intervention and at one year; (ii) parents increase their knowledge and skills in understanding and managing their child’s challenging RRB; (iii) children show a reduction in challenging RRB, and change in participation in everyday activities, parent stress and impact on family life; (iv) the intervention provides value for money for the NHS. MRB is a manualised intervention designed to help parents of young children with ASD to recognise, understand and learn how to manage their child’s challenging RRB (e.g. predictable disruptive spinning on the spot while screaming). In order to help parents tailor strategies they need to understand the role RRB may have for their child, perhaps as an inappropriate coping strategy to manage situational stressors such as everyday sensory experiences or anxiety (e.g extreme meltdown to the swishing sound of automatic doors). The manualised MRB intervention and evaluation research protocol has been developed in partnership with parents of young children with ASD. A pilot study established feasibility and acceptability of the study design (e.g. parents understood the scientific need for random allocation to groups) and valued the intervention "It was good to think about my own reactions and the effect they had on his behaviour”. Successful intervention to manage challenging RRB would reduce the deleterious consequences of a restricted range of activities, facilitate the child’s ability to engage with their family and environment and reduce longer term burden on families and service providers. If shown to be effective and value for money, the MRB parent group intervention would increase locally available therapeutic skills and resources. The results of the study will be shared as follows: 1. Local dissemination at each site including parent newsletters 2. Wider national and international dissemination including conferences and publications 3. NHS Clinicians and Commissioners events to discuss the implications of the research

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH