Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol
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
Affiliations
Jonathan Green
21 Division of Neuroscience & Experimental Psychology, The University of Manchester, Manchester, UK
Amaria Baghdadli
UVSQ, Inserm, CESP, “DevPsy”, Paris-Saclay University, Villejuif, France
Marie-Maude Geoffray
Academic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, France
Thierry Maffre
Service Universitaire de Psychiatrie de l’Enfant et de l’Adolescent, Centre de Ressources Autisme Midi-Pyrénées, CHU de Toulouse, Toulouse, France
Sandrine Touzet
Research on Healthcare Performance (RESHAPE), INSERM U1290, Universite Claude Bernard Lyon 1, Lyon, France
Pauline Occelli
Public Health Department, Hospices Civils de Lyon, F-69003 Lyon, France
Angelique Denis
Service de Biostatistique, Hospices Civils de Lyon, Lyon, France
Anne Revah-Levy
Centre de Soins Psychotherapeutiques de Transition pour Adolescents, Argenteuil Health and Social Services Centre, Lachute, Quebec, Canada
Lucie Jurek
Academic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, France
Anouck Amestoy
Child and Adolescent Psychiatry, Centre Hospitalier Charles Perrens, Bordeaux, France
Tom Dauchez
Child and Adolescent Psychiatry, Centre Hospitalier Charles Perrens, Bordeaux, France
Marie-Joelle Oreve
Service Universitaire de Psychiatrie de lEnfant et de lAdolescent, Centre Hospitalier de Versailles, Le Chesnay, France
Carmen Schroder
Department of Child and Adolescent Psychiatry, Hopitaux universitaires de Strasbourg, Strasbourg, France
Agathe Jay
Academic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, France
Amélie Zelmar
Research on Healthcare Performance (RESHAPE), INSERM U1290, Universite Claude Bernard Lyon 1, Lyon, France
Natacha Gallifet
Academic department of Child and adolescent neurodevelopmental psychiatry, Hospital Centre Vinatier, Bron, France
Catherine aldred
The University of Manchester, Manchester, UK
Shruti Garg
Division of Neuroscience and Experimental Psychology, Faculty of Biological Medical & Health Sciences, The University of Manchester, Manchester, UK
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.
