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.

Content Provider	Europe PMC
Author	McLay, Laurie Emerson, Lisa Marie Waddington, Hannah van Deurs, Jenna Hunter, Jolene Blampied, Neville Hapuku, Aaron Macfarlane, Sonja Bowden, Nicholas van Noorden, Lauren Rispoli, Mandy
Copyright Year	2023
Abstract	IntroductionTimely 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 analysisThe 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 disseminationThe 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 numberAustralian New Zealand Clinical Trials Registry (ACTRN12622001134718).
Journal	BMJ Open
Volume Number	13
PubMed Central reference number	PMC10254711
Issue Number	5
PubMed reference number	37253492
e-ISSN	20446055
DOI	10.1136/bmjopen-2022-071235
Language	English
Publisher	BMJ Publishing Group
Publisher Date	2023-05-30
Publisher Place	London
Access Restriction	Open
Rights License	This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Subject Keyword	MENTAL HEALTH Developmental neurology & neurodisability Clinical trials Community child health
Content Type	Text
Resource Type	Article
Subject	Medicine