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

Type of content
Journal Article
Thesis discipline
Degree name
Publisher
BMJ
Journal Title
Journal ISSN
Volume Title
Language
eng
Date
2023
Authors
McLay, Laurie
Emerson, Lisa-Marie
Waddington H
van Deurs, Jenna
Hunter J
Blampied, Neville
Hāpuku, Aaron
Macfarlane, Sonja
Bowden N
Van Noorden L
Abstract

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).

Description
Citation
McLay L, Emerson LM, Waddington H, Van Deurs J, Hunter J, Blampied N, Hapuku A, Macfarlane S, Bowden N, Van Noorden L, Rispoli M (2023). 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. 13(5). e071235-.
Keywords
Humans, Single-Blind Method, Autistic Disorder, Telemedicine, Adult, Child, Preschool, Caregivers, Australia, Randomized Controlled Trials as Topic, Acceptance and Commitment Therapy
Ngā upoko tukutuku/Māori subject headings
Hauora | Health::Take hauora | Health issues::Hauātanga | Disabilities
Hauora | Health::Ora | Alive; Living; Well-being::Hauora hinengaro | Mental health
Hauora | Health::Ora | Alive; Living; Well-being
Hauora | Health::Ora | Alive; Living; Well-being::Hauora hinengaro | Mental health::Manaaki tangata | Counselling, Personal; Personal counselling
Mātauranga | Education
ANZSRC fields of research
39 - Education::3904 - Specialist studies in education::390411 - Special education and disability
42 - Health sciences::4203 - Health services and systems::420318 - People with disability
42 - Health sciences::4203 - Health services and systems::420303 - Family care
42 - Health sciences::4203 - Health services and systems::420305 - Health and community services
42 - Health sciences::4206 - Public health::420601 - Community child health
42 - Health sciences::4206 - Public health::420605 - Preventative health care
42 - Health sciences::4203 - Health services and systems::420313 - Mental health services
52 - Psychology::5201 - Applied and developmental psychology::520101 - Child and adolescent development
52 - Psychology::5201 - Applied and developmental psychology::520102 - Educational psychology
52 - Psychology::5203 - Clinical and health psychology
45 - Indigenous studies::4510 - Te hauora me te oranga o te Māori (Māori health and wellbeing)
45 - Indigenous studies::4508 - Mātauranga Māori (Māori education)
45 - Indigenous studies::4510 - Te hauora me te oranga o te Māori (Māori health and wellbeing)::451001 - Te whaikaha me te Māori (Māori and disability)
Rights
All rights reserved unless otherwise stated