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A clinical and cost-effectiveness trial of a parent group intervention to manage challenging restricted and repetitive behaviours in young children with autism spectrum disorder: study protocol for a randomised controlled trial.
Grahame, Victoria; Dixon, Linda; Fletcher-Watson, Sue; Garland, Deborah; Glod, Magdalena; Goodwin, Jane; Grayson, Zoe; Heron, Saoirse; Honey, Emma; Iversen, Rebecca; Kasim, Adetayo S; Kernohan, Ashleigh; Kharatikoopaei, Ehsan; Le Couteur, Ann; Mackie, Leila; Mathias, Ayesha; Probert, Helen; Riby, Deborah; Rob, Priyanka; Rogan, Leanne; Thompson, Sarah; Vale, Luke; Walls, Eamonn; Webb, Elspeth Imogen; Weetman, Christopher; Wolstenhulme, Faye; Wood, Ruth; Rodgers, Jacqui.
Afiliación
  • Grahame V; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Complex Neurodevelopmental Disorder Service (CNDS), Walkergate Park, Benfield Road, Newcastle upon Tyne, NE6 4QD, UK. Victoria.Grahame@cntw.nhs.uk.
  • Dixon L; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Complex Neurodevelopmental Disorder Service (CNDS), Walkergate Park, Benfield Road, Newcastle upon Tyne, NE6 4QD, UK.
  • Fletcher-Watson S; Salvesen Mindroom Research Centre, The University of Edinburgh, Kennedy Tower, Morningside Terrace, Edinburgh, EH10 5HF, UK.
  • Garland D; National Autistic Society, North East Resource Centre, Newcastle upon Tyne, NE5 2LW, UK.
  • Glod M; Population Health Sciences Institute, Newcastle University, Level 3, Sir James Spence Institute, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.
  • Goodwin J; Population Health Sciences Institute, Newcastle University, Level 3, Sir James Spence Institute, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.
  • Grayson Z; Salvesen Mindroom Research Centre, Child Life and Health, Royal Hospital for Sick Children, Edinburgh, EH9 1LF, UK.
  • Heron S; Royal Edinburgh Hospital, Kennedy Tower, Morningside Terrace, Edinburgh, EH10 5HF, UK.
  • Honey E; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Complex Neurodevelopmental Disorder Service (CNDS), Walkergate Park, Benfield Road, Newcastle upon Tyne, NE6 4QD, UK.
  • Iversen R; Royal Edinburgh Hospital, Kennedy Tower, Morningside Terrace, Edinburgh, EH10 5HF, UK.
  • Kasim AS; Durham Research Methods Centre, Durham University, South Road, Durham, DH1 3LE, UK.
  • Kernohan A; Population Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AA, UK.
  • Kharatikoopaei E; Department of Anthropology, Durham University, South Rd, Durham, DH1 3LE, UK.
  • Le Couteur A; Population Health Sciences Institute, Newcastle University, Level 3, Sir James Spence Institute, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.
  • Mackie L; Salvesen Mindroom Research Centre, Child Life and Health, Royal Hospital for Sick Children, Edinburgh, EH9 1LF, UK.
  • Mathias A; Newcastle Clinical Trials Unit, Newcastle University 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
  • Probert H; Psychology Department, Durham University, Science Laboratories, South Road, Durham, DH1 3LE, UK.
  • Riby D; Psychology Department, Durham University, Science Laboratories, South Road, Durham, DH1 3LE, UK.
  • Rob P; Population Health Sciences Institute, Newcastle University, Level 3, Sir James Spence Institute, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.
  • Rogan L; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Complex Neurodevelopmental Disorder Service (CNDS), Walkergate Park, Benfield Road, Newcastle upon Tyne, NE6 4QD, UK.
  • Thompson S; Psychology Department, Durham University, Science Laboratories, South Road, Durham, DH1 3LE, UK.
  • Vale L; Population Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AA, UK.
  • Walls E; Royal Edinburgh Hospital, Kennedy Tower, Morningside Terrace, Edinburgh, EH10 5HF, UK.
  • Webb EI; Derwentside CAMHS, 192 Medomsley Road, Consett, DH8 5HT, UK.
  • Weetman C; Newcastle Clinical Trials Unit, Newcastle University 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
  • Wolstenhulme F; Newcastle Clinical Trials Unit, Newcastle University 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
  • Wood R; Newcastle Clinical Trials Unit, Newcastle University 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
  • Rodgers J; Population Health Sciences Institute, Newcastle University, Level 3, Sir James Spence Institute, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.
Trials ; 22(1): 240, 2021 Apr 01.
Article en En | MEDLINE | ID: mdl-33794962
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastorno Autístico / Trastorno del Espectro Autista Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Health_economic_evaluation / Prognostic_studies Límite: Child / Child, preschool / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastorno Autístico / Trastorno del Espectro Autista Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Health_economic_evaluation / Prognostic_studies Límite: Child / Child, preschool / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido