Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol
Introduction Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained im...
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BMJ Publishing Group
2021-04-01
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Series: | BMJ Open |
Online Access: | https://bmjopen.bmj.com/content/11/4/e044669.full |
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doaj-ca96f0d6e1aa41d7b6247400fcd181b2 |
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Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jonathan Green Amaria Baghdadli Marie-Maude Geoffray Thierry Maffre Sandrine Touzet Pauline Occelli Angelique Denis Anne Revah-Levy Lucie Jurek Anouck Amestoy Tom Dauchez Marie-Joelle Oreve Carmen Schroder Agathe Jay Amélie Zelmar Natacha Gallifet Catherine aldred Shruti Garg |
spellingShingle |
Jonathan Green Amaria Baghdadli Marie-Maude Geoffray Thierry Maffre Sandrine Touzet Pauline Occelli Angelique Denis Anne Revah-Levy Lucie Jurek Anouck Amestoy Tom Dauchez Marie-Joelle Oreve Carmen Schroder Agathe Jay Amélie Zelmar Natacha Gallifet Catherine aldred Shruti Garg Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol BMJ Open |
author_facet |
Jonathan Green Amaria Baghdadli Marie-Maude Geoffray Thierry Maffre Sandrine Touzet Pauline Occelli Angelique Denis Anne Revah-Levy Lucie Jurek Anouck Amestoy Tom Dauchez Marie-Joelle Oreve Carmen Schroder Agathe Jay Amélie Zelmar Natacha Gallifet Catherine aldred Shruti Garg |
author_sort |
Jonathan Green |
title |
Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol |
title_short |
Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol |
title_full |
Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol |
title_fullStr |
Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol |
title_full_unstemmed |
Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol |
title_sort |
efficacy of parent-mediated communication-focused treatment in toddlers with autism (pact) delivered via videoconferencing: a randomised controlled trial study protocol |
publisher |
BMJ Publishing Group |
series |
BMJ Open |
issn |
2044-6055 |
publishDate |
2021-04-01 |
description |
Introduction Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas.Methods and analysis This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18–36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect.Ethics and dissemination This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journalsTrial registration number NCT04244721. |
url |
https://bmjopen.bmj.com/content/11/4/e044669.full |
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doaj-ca96f0d6e1aa41d7b6247400fcd181b22021-07-23T15:00:58ZengBMJ Publishing GroupBMJ Open2044-60552021-04-0111410.1136/bmjopen-2020-044669Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocolJonathan Green0Amaria Baghdadli1Marie-Maude Geoffray2Thierry Maffre3Sandrine Touzet4Pauline Occelli5Angelique Denis6Anne Revah-Levy7Lucie Jurek8Anouck Amestoy9Tom Dauchez10Marie-Joelle Oreve11Carmen Schroder12Agathe Jay13Amélie Zelmar14Natacha Gallifet15Catherine aldred16Shruti Garg17Division of Neuroscience and Experimental Psychology, Faculty of Biological Medical & Health Sciences, The University of Manchester, Manchester, UKCenter of ressources in Autism and Center of Excellence in Autism and Neurodevelopment disorders, University Hospital Centre Montpellier, Montpellier, FranceAcademic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, FranceService Universitaire de Psychiatrie de l’Enfant et de l’Adolescent, Centre de Ressources Autisme Midi-Pyrénées, University Hospital Centre Toulouse, Toulouse, FranceResearch on Healthcare Performance (RESHAPE), INSERM U1290, Universite Claude Bernard Lyon 1, Lyon, FranceResearch on Healthcare Performance (RESHAPE), INSERM U1290, Universite Claude Bernard Lyon 1, Lyon, FrancePôle de santé publique, Hospices Civils de Lyon, Lyon, FranceCentre de Soins Psychotherapeutiques de Transition pour Adolescents, Argenteuil Health and Social Services Centre, Lachute, Quebec, CanadaAcademic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, FranceChild and Adolescent Psychiatry, Centre Hospitalier Charles Perrens, Bordeaux, FranceChild and Adolescent Psychiatry, Centre Hospitalier Charles Perrens, Bordeaux, FranceService Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Centre Hospitalier de Versailles, Le Chesnay, FranceDepartment of Child and Adolescent Psychiatry, Hopitaux universitaires de Strasbourg, Strasbourg, FranceAcademic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, FranceResearch on Healthcare Performance (RESHAPE), INSERM U1290, Universite Claude Bernard Lyon 1, Lyon, FranceAcademic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, FranceThe University of Manchester, Manchester, UKDivision of Neuroscience and Experimental Psychology, Faculty of Biological Medical & Health Sciences, The University of Manchester, Manchester, UKIntroduction Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas.Methods and analysis This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18–36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect.Ethics and dissemination This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journalsTrial registration number NCT04244721.https://bmjopen.bmj.com/content/11/4/e044669.full |