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Lookup NU author(s): Dr Victoria Grahame, Dr Sue Fletcher-Watson, Deborah Garland, Dr Magda GlodORCiD, Dr Jane Goodwin, Dr Emma Honey, Dr Ashleigh KernohanORCiD, Professor Ann Le Couteur, Ayesha Mathias, Dr Debbie Riby, Priyanka RobORCiD, Leanne Rogan, Sarah Thompson, Professor Luke ValeORCiD, Christopher Weetman, Dr Faye WolstenhulmeORCiD, Ruth Wood, Emerita Professor Jacqueline Rodgers
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2021, The Author(s). Background: Restricted and repetitive behaviours vary greatly across the autism spectrum, and although not all are problematic some can cause distress and interfere with learning and social opportunities. We have, alongside parents, developed a parent group based intervention for families of young children with autism, which aims to offer support to parents and carers; helping them to recognise, understand and learn how to respond to their child’s challenging restricted repetitive behaviours. Methods: The study is a clinical and cost-effectiveness, multi-site randomised controlled trial of the Managing Repetitive Behaviours (MRB) parent group intervention versus a psychoeducation parent group Learning About Autism (LAA) (n = 250; 125 intervention/125 psychoeducation; ~ 83/site) for parents of young children aged 3–9 years 11 months with a diagnosis of autism. All analyses will be done under intention-to-treat principle. The primary outcome at 24 weeks will use generalised estimating equation (GEE) to compare proportion of children with improved RRB between the MRB group and the LAA group. The GEE model will account for the clustering of children by parent groups using exchangeable working correlation. All secondary outcomes will be analysed in a similar way using appropriate distribution and link function. The economic evaluation will be conducted from the perspective of both NHS costs and family access to local community services. A ‘within trial’ cost-effectiveness analysis with results reported as the incremental cost per additional child achieving at least the target improvement in CGI-I scale at 24 weeks. Discussion: This is an efficacy trial to investigate the clinical and cost-effectiveness of a parent group based intervention designed to help parents understand and manage their child’s challenging RRB. If found to be effective, this intervention has the potential to improve the well-being of children and their families, reduce parental stress, greatly enhance community participation and potential for learning, and improve longer-term outcomes. Trial registration: Trial ID: ISRCTN15550611 Date registered: 07/08/2018. Sponsor and Monitor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust R&D Manager Lyndsey Dixon, Address: St Nicholas Hospital, Jubliee Road, Gosforth, Newcastle upon Tyne NE3 3XT, lyndsey.dixon@cntw.nhs.uk, Tel: 0191 246 7222
Author(s): Grahame V, Dixon L, Fletcher-Watson S, Garland D, Glod M, Goodwin J, Grayson Z, Heron S, Honey E, Iversen R, Kasim AS, Kernohan A, Kharatikoopaei E, Le Couteur A, Mackie L, Mathias A, Probert H, Riby D, Rob P, Rogan L, Thompson S, Vale L, Walls E, Webb EI, Weetman C, Wolstenhulme F, Wood R, Rodgers J
Publication type: Article
Publication status: Published
Journal: Trials
Year: 2021
Volume: 22
Issue: 1
Online publication date: 01/04/2021
Acceptance date: 08/03/2021
Date deposited: 22/04/2021
ISSN (electronic): 1745-6215
Publisher: BioMed Central Ltd
URL: https://doi.org/10.1186/s13063-021-05175-y
DOI: 10.1186/s13063-021-05175-y
PubMed id: 33794962
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