Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial

Introduction Timely access to early support that optimises autistic children’s development and their caregiver’s mental health is critical. Naturalistic developmental behavioural interventions (NDBIs) and acceptance and commitment therapy (ACT) are evidence-based supports that can enhance child lear...

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Main Authors: Laurie McLay, Lisa Marie Emerson, Hannah Waddington, Jenna van Deurs, Jolene Hunter, Neville Blampied, Aaron Hapuku, Sonja Macfarlane, Nicholas Bowden, Lauren van Noorden, Mandy Rispoli
Format: Article
Language:English
Published: BMJ Publishing Group 2023-05-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/5/e071235.full
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author Laurie McLay
Lisa Marie Emerson
Hannah Waddington
Jenna van Deurs
Jolene Hunter
Neville Blampied
Aaron Hapuku
Sonja Macfarlane
Nicholas Bowden
Lauren van Noorden
Mandy Rispoli
author_facet Laurie McLay
Lisa Marie Emerson
Hannah Waddington
Jenna van Deurs
Jolene Hunter
Neville Blampied
Aaron Hapuku
Sonja Macfarlane
Nicholas Bowden
Lauren van Noorden
Mandy Rispoli
author_sort Laurie McLay
collection DOAJ
description Introduction Timely access to early support that optimises autistic children’s development and their caregiver’s mental health is critical. Naturalistic developmental behavioural interventions (NDBIs) and acceptance and commitment therapy (ACT) are evidence-based supports that can enhance child learning and behaviour, and adult well-being, respectively. The traditional face-to-face delivery of these approaches is resource intensive. Further, little is known about the benefit of parallel child-focused and caregiver-focused supports. The aims of this trial are to evaluate the effectiveness and social validity of telehealth-delivered, caregiver-implemented, child-focused NDBI and caregiver-focused ACT when delivered alone and in parallel, on autistic children’s social communication and caregiver well-being.Methods and analysis The study will use a randomised, single-blind clinical trial with three parallel arms: NDBI; ACT and ACT+NDBI. We will recruit a minimum of 78, 2–5-year-old autistic children and their families throughout Aotearoa New Zealand. Support will be delivered over 13 weeks using a combination of culturally enhanced web-based modules and online group coaching. Primary outcome variables include children’s social communication/engagement with their caregiver as well as caregiver stress and will be evaluated using a repeated measures multivariate analysis of variance. Outcome variables are assessed at baseline (before randomisation), immediately postparticipation and at 3-month follow-up.Ethics and dissemination The trial is approved by the Health and Disability Ethics Committee (2022 FULL 12058). The findings of this trial will be disseminated through peer-reviewed journals and national and international conference proceedings regardless of the magnitude/direction of effect. Additionally, data will be shared with stakeholder groups, service providers and health professionals.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12622001134718).
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spelling doaj.art-b2cafa2f68ea4da6814f9f2100d3c4cc2023-05-30T21:00:07ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2022-071235Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trialLaurie McLay0Lisa Marie Emerson1Hannah Waddington2Jenna van Deurs3Jolene Hunter4Neville Blampied5Aaron Hapuku6Sonja Macfarlane7Nicholas Bowden8Lauren van Noorden9Mandy Rispoli10Faculty of Health, University of Canterbury, Christchurch, New ZealandFaculty of Health, University of Canterbury, Christchurch, New ZealandFaculty of Education, Victoria University of Wellington, Wellington, New ZealandFaculty of Health, University of Canterbury, Christchurch, New ZealandFaculty of Health, University of Canterbury, Christchurch, New ZealandSchool of Psychology, Speech, and Hearing, University of Canterbury, Christchurch, New ZealandFaculty of Health, University of Canterbury, Christchurch, New ZealandInstitute of Education, Massey University, Palmerston North, New ZealandDepartment of Women’s and Children’s Health, University of Otago, Dunedin, New ZealandFaculty of Health, University of Canterbury, Christchurch, New ZealandSchool of Education and Human Development, University of Virginia, Charlottesville, Virginia, USAIntroduction Timely access to early support that optimises autistic children’s development and their caregiver’s mental health is critical. Naturalistic developmental behavioural interventions (NDBIs) and acceptance and commitment therapy (ACT) are evidence-based supports that can enhance child learning and behaviour, and adult well-being, respectively. The traditional face-to-face delivery of these approaches is resource intensive. Further, little is known about the benefit of parallel child-focused and caregiver-focused supports. The aims of this trial are to evaluate the effectiveness and social validity of telehealth-delivered, caregiver-implemented, child-focused NDBI and caregiver-focused ACT when delivered alone and in parallel, on autistic children’s social communication and caregiver well-being.Methods and analysis The study will use a randomised, single-blind clinical trial with three parallel arms: NDBI; ACT and ACT+NDBI. We will recruit a minimum of 78, 2–5-year-old autistic children and their families throughout Aotearoa New Zealand. Support will be delivered over 13 weeks using a combination of culturally enhanced web-based modules and online group coaching. Primary outcome variables include children’s social communication/engagement with their caregiver as well as caregiver stress and will be evaluated using a repeated measures multivariate analysis of variance. Outcome variables are assessed at baseline (before randomisation), immediately postparticipation and at 3-month follow-up.Ethics and dissemination The trial is approved by the Health and Disability Ethics Committee (2022 FULL 12058). The findings of this trial will be disseminated through peer-reviewed journals and national and international conference proceedings regardless of the magnitude/direction of effect. Additionally, data will be shared with stakeholder groups, service providers and health professionals.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12622001134718).https://bmjopen.bmj.com/content/13/5/e071235.full
spellingShingle Laurie McLay
Lisa Marie Emerson
Hannah Waddington
Jenna van Deurs
Jolene Hunter
Neville Blampied
Aaron Hapuku
Sonja Macfarlane
Nicholas Bowden
Lauren van Noorden
Mandy Rispoli
Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial
BMJ Open
title Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial
title_full Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial
title_fullStr Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial
title_full_unstemmed Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial
title_short Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial
title_sort telehealth delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers protocol for a multi arm parallel group randomised clinical trial
url https://bmjopen.bmj.com/content/13/5/e071235.full
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