ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001134718

Ethics application status

Approved

Date submitted

15/08/2022

Date registered

17/08/2022

Date last updated

17/08/2022

Date data sharing statement initially provided

17/08/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Telehealth-delivered supports for enhancing the social communication of autistic children and caregiver wellbeing

Scientific title

Telehealth-delivered Naturalistic Developmental Behavioral Intervention with and without Caregiver Acceptance and Commitment Therapy for Autistic Children and their Caregivers: A Multi-arm Parallel Group Randomized Clinical Trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism Spectrum Disorder

Social communication difficulties

Parent stress

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Supports

Support Arm 1: ACT (ACTion in Caregiving)
The Acceptance and Commitment Therapy (ACT) program developed for this project (named ACTion in Caregiving) is designed to support caregiver mental health. This program will last 13 weeks and includes access to six two-weekly (self-directed) web-based modules (available at this website: https://waioratamariki.org.nz/act/) accompanied by seven caregiver group sessions conducted via Zoom. Modules will be released two-weekly, and associated group sessions will focus on one of the six core components of ACT. Module 1 will illustrate the futility of controlling thoughts and feelings and introduces participants to acceptance/willingness processes as well as values. Module 2 introduces mindfulness and teaches caregivers how to apply this within daily life. Module 3 focuses on identifying caregiver cognitive fusion and teaches techniques to facilitate defusion. Module 4 introduces self-as-context and applying awareness, acceptance, and defusion to this. Module 5 focuses on values-based living (e.g., ongoing clarification of values, using values as a guide for action). Finally, Module 6 explores how to take action to live by values (e.g., goal-setting), while managing vulnerabilities & processes of psychological inflexibility.

Participants will be randomly divided into cohorts of 6-8 primary caregivers who will participate in group sessions together. The first session will orient participants to the program and introduce participants and facilitators. Participants will be encouraged to say a mihimihi/pepeha (greeting speech to introduce themselves) in their preferred language to facilitate whanaungatanga (connections between participants). Following this session, the cohort will be granted access to the first web-based module. Group sessions will last up to 2 hours and include a module summary, discussion of homework assignments and participant reflections, trouble-shooting, and tailoring strategies to the individual and their family. The agenda will be co-led by caregiver participants to address the needs of each cohort. All group sessions will follow elements of Maori tikanga, such as opening and closing the session with a karakia (prayer) or whakatauki (proverb/significant saying), and draw on hui and powhiri processes (rituals of encounter) including whaikorero (collaborative therapeutic discussion) and poroporoaki (acknowledging what has taken place and participant’s plans from here).

Web-based content will be presented using written text, video presentations/examples, pictures, and audio files, to ensure it is accessible to a range of learning styles and reading comprehension abilities. The ACTion in Caregiving website includes te ao Maori (Maori worldview) imagery (e.g., koru designs) to symbolize parent growth, nurturing of their wellbeing, caregiver-child connections, and mindfulness. Established ACT techniques and metaphors will be adapted to suit an Aotearoa New Zealand (NZ) audience and te reo Maori will be incorporated throughout. Modules are designed to take up to 1 hour to complete. Participants will receive written instructions during the modules to engage in worksheets, experiential exercises (e.g., thought suppression strategies) and therapeutic activities (e.g., mindfulness meditations) to facilitate understanding of ACT concepts and consolidate learning. Homework practices will be set at the end of each module to facilitate regular practice of ACT techniques and to assist caregivers with applying newly learned skills in daily life. In addition, caregivers will be given the opportunity to engage in an online discussion forum with others in their cohort, however participation is optional. The forum will be monitored by therapists who will also respond to any caregiver questions.

Support Arm 2: NDBI (Play to Learn)
The Naturalistic Developmental Behavioral Intervention (NDBI) program created for this project (named Play to Learn) is designed to support the development of social communication skills in autistic children. It will follow the same format as the ACTion in Caregiving program (i.e., will last 13 weeks and consist of six 1-hour web-based modules [available at this website: https://waioratamariki.org.nz/ndbi/] accompanied by seven 2-hour caregiver group [n = 6 – 8] coaching sessions). Modules and aligned group sessions will focus on core elements of NDBI. Module 1 provides caregivers with knowledge about how to engage their child and follow their lead. Module 2 focuses on engaging through play (with people & objects) and incorporating the techniques learnt in everyday routines. Module 3 provides foundational knowledge related to the principles of learning (e.g., role of antecedents & consequences) and applies this to teaching children new skills. Module 4 teaches the application of principles of learning to replacing behaviors that are harmful to the child, others, or property. Modules 5 and 6 focus on teaching non-verbal and verbal communication respectively using behavioral techniques (e.g., modelling, creating opportunities) and visual supports.

Web-based Play to Learn content will be presented in a range of formats (as in ACTion in Caregiving). Video exemplars will represent families from a diverse range of cultures (e.g., Maori, Pacific peoples) and te reo Maori terminology will be incorporated within program content and resources. Te ao Maori imagery for the Play to Learn website utilizes ngutukaka (plant shaped like parrot beak) and mangopare (hammer head shark known for its strength) border designs representing communication and strengthening social connections. Participants will be provided with relevant resources and directions regarding how to create their own versions (e.g., social stories). As in the ACTion in Caregiving program, participants in the NDBI group will receive guidance on strategies they can practice in the home, are encouraged to set weekly homework goals regarding the relevant strategies they will try and use should the opportunity arise (e.g., setting up the environment for learning, faciliating turn-taking) and can engage in an online discussion forum. Prior to each Play to Learn group session, participants will be given the option to share video recordings of themselves using NDBI techniques in order to receive feedback from facilitators.

Support Arm 3: ACT + NDBI
Families in the combined support group will participate in the ACTion in Caregiving and Play to Learn programs concurrently. Group sessions will occur during alternate weeks (i.e., ACTion in Caregiving sessions will occur on odd-numbered weeks and Play to Learn sessions on even-numbered weeks).

Group sessions across all support arms will be co-facilitated by a practitioner (i.e., psychologists, intern psychologists, or PhD students [trained in NDBI and ACT]), and a caregiver of an autistic child. Groups that include Maori participants will be co-facilitated by a Maori caregiver of an autistic child. Maori participants will also be given the opportunity to engage in an online discussion forum for Maori caregivers only. Caregiver co-facilitators will not need to be trained in ACT nor NDBI as their role is to relate to the experience of raising an autistic child and facilitate related conversations, as opposed to providing therapeutic advice. However, they will be provided with access to modules prior to coaching sessions. There will only be a small number of clinical and caregiver facilitators in order to maintain integrity in program delivery by ensuring consistent levels of training and performance.

If caregivers have not logged into the web-based program for 7 days they will receive a text or email reminder from a member of the research team to engage in the content prior to the group session, however, they can opt out of receiving these alerts. Follow up phone calls will be made by the group facilitators to caregivers if they do not attend group sessions to clarify reasons for non-attendance. Families will be able to access the web-based programs independently post-participation.

Intervention code [1]

Behaviour

Comparator / control treatment

The comparator is the ACT (ACTion in Caregiving) + NDBI (Play to Learn) support arm.

Control group

Active

Outcomes

Primary outcome [1]

The primary child outcome measure is the difference in child engagement across baseline, post-participation, and at 6-month follow-up. Naturalistic play episodes at home (10 min) between a child and their caregiver will be video recorded by participants at each time point. Bakeman and Adamson’s (1984) method for measuring child engagement will be used to evaluate the percentage of child engagement demonstrated in the videos.

Timepoint [1]

Child engagement during naturalistic play episodes will be collected pre-randomization, immediately post-support, and at 6-month follow-up.

Primary outcome [2]

The primary caregiver outcome measure is the difference in caregiver stress, as measured by the Parenting Stress Index - Fourth Edition, Short Form (PSI-4-SF, Abidin, 2012) Parental Distress (PD) subscale.

Timepoint [2]

The PSI-4-SF will be completed by caregivers pre-randomization, immediately post-support, and at 6-month follow-up.

Secondary outcome [1]

Change in child social communication as measured by the Social Responsiveness Scale Preschool Form, Second Edition (SRS-2; Constantino & Gruber, 2012).

Timepoint [1]