Trial Review

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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] 307773 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 327349 0
Social communication difficulties 327350 0
Parent stress 327351 0
Condition category
Condition code
Mental Health 324475 324475 0 0
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] 324238 0
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] 332299 0
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] 332299 0
Child engagement during naturalistic play episodes will be collected pre-randomization, immediately post-support, and at 6-month follow-up.
Primary outcome [2] 332300 0
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] 332300 0
The PSI-4-SF will be completed by caregivers pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [1] 412882 0
Change in child social communication as measured by the Social Responsiveness Scale Preschool Form, Second Edition (SRS-2; Constantino & Gruber, 2012).
Timepoint [1] 412882 0
Pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [2] 412883 0
Change in child internalizing and externalizing behavior as measured by the Child Behavior Checklist for Ages 1.5 – 5 (CBCL; Achenbach, 2001).
Timepoint [2] 412883 0
Pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [3] 412884 0
Change in child adaptive behavior as measured by the Vineland Adaptive Behavior Scale, Third Edition (Vineland-3; Sparrow et al., 2016).
Timepoint [3] 412884 0
Pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [4] 412885 0
Change in child speech and language will be measured by transcribing and analyzing the speech and language evident within the 10-minute video observations used for the child engagement measure. The Systematic Analysis of Language Transcripts, New Zealand/Australia (SALT-NZAU; Miller et al., 2015) will be used to analyze the footage and detect changes.
Timepoint [4] 412885 0
Pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [5] 412888 0
Change in caregiver psychological distress will be measured by the Depression, Anxiety, and Stress Scale-21 (DASS-21; Henry & Crawford, 2005).
Timepoint [5] 412888 0
Pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [6] 412889 0
Change in caregiver experiential avoidance will be measured with the Parental Acceptance and Action Questionnaire (PAAQ; Cheron, 2009).
Timepoint [6] 412889 0
Pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [7] 412890 0
Change in caregiver self-esteem will be measured using the Parent Sense of Competence Scale (PSOC; Johnston & Mash, 1989).
Timepoint [7] 412890 0
Pre-randomization, immediately post-support, and at 6-month follow-up.
Secondary outcome [8] 412891 0
A composite secondary outcome is the social validity of the support programs (including cultural acceptability) which will be measured by both The Treatment Acceptability Rating Form-Revised (TARF-R; Reimers et al., 1992) questionnaire and a 30-minute semi-structured interview administered over the phone or via Zoom. The interview will be conducted by a member of the research team.
Timepoint [8] 412891 0
Immediately post-support.
Secondary outcome [9] 412894 0
Caregiver use of ACT practices will be measured using a weekly log. Caregivers will also be required to record the amount of professional support received in these logs, wherein they note the type and duration (mins) of service.
Timepoint [9] 412894 0
The logs will be completed weekly by caregivers during the support phase and for 1 week immediately post-support and at 6-month follow up.
Secondary outcome [10] 412895 0
Therapist procedural integrity in delivery of ACTion in Caregiving and Play to Learn group sessions will be assessed by an independent observer for at least 20% of sessions using a checklist developed specifically for this study.
Timepoint [10] 412895 0
Therapist procedural integrity will be measured during the support phase for at least 20% of the group sessions.
Secondary outcome [11] 412896 0
Website analytics (e.g., frequency and duration of engagement with website components) and group session attendance will provide a measure of support dosage.
Timepoint [11] 412896 0
Website analytics will be examined immediately post-support.
Secondary outcome [12] 413018 0
Caregiver use of NDBI practices will be measured using a weekly log. Caregivers will also be required to record the amount of professional support received in these logs, wherein they note the type and duration (mins) of service. The 10-minute video observations used for the child engagement measure and language analyses will also be analyzed to evaluate caregiver use of NDBI strategies.
Timepoint [12] 413018 0
The logs will be completed weekly by caregivers during the support phase and for 1 week immediately post-support and at 6-month follow up. The 10-minute video observations will be collected once pre-randomization, immediately post-support, and at 6-month follow-up.

Eligibility
Key inclusion criteria
: (1) the child has a formal diagnosis of autism or has been identified as having a high likelihood of being autistic by an appropriately qualified clinician (i.e., psychologist, psychiatrist, pediatrician) and confirmed by a “high likelihood” score on the Social Attention and Communication Surveillance–Revised (SACS-R) or SACS-Preschool (SACS-PR; Barbaro & Dissanayake, 2010) instrument; (2) the child is between 2 years 0 months and 5 years 11 months of age at the first point of contact (i.e., screening); (3) the primary caregiver involved in the trial speaks sufficient English to understand study requirements and written content, and to participate in group sessions; (4) the primary caregiver consents to randomization
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) the child is attending primary school; (2) the child is receiving more than 15 hours a week of professionally-delivered support; (3) the caregiver is currently engaged in another parenting program; and (4) the child has a sibling or twin already participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent statistician will conduct the randomization process and give the randomization schedule to an independent research assistant who will enclose assignments in sequentially numbered sealed envelopes. When each participant has completed the enrolment phase the project coordinator will open the next envelope and inform the participant which condition they have been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study will be a multi-arm parallel group, single blind (rater), randomized clinical trial. Caregiver-child dyads will be randomly allocated to one of three support arms: ACT alone, NDBI alone, or NDBI+ACT, which each act as active control groups. Randomization will be performed as block randomization with a 1:1:1 allocation using minimization and stratification by ethnicity (participants who self-identify as Maori or non-Maori). The independent statistician will use a computerized sequence generation to create a randomization table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimates were calculated a priori (power =0.80; alpha=0.05) and indicated that a minimum of 78 caregiver/child dyads (N = 26/group) is sufficient to detect a large effect (d = 0.80) for the primary analysis. Effect size estimates were based on Kasari et al., (2010) which demonstrated a strong effect size (Cohen’s d = 0.87) following caregiver implementation of the JASPER program with autistic toddlers. The stated sample size allows for 15% attrition between pre- and post-participation.

Firstly, an exploratory analysis of the data will be conducted, identifying missing data, examining means, standard deviations, and ranges of each variable at each time point, examining the distribution of scores, checking for outliers, and examining the correlation matrix of Pearson's r to check for multicollinearity. Second, the three support groups (ACT; NDBI; ACT + NDBI) will be compared for equivalency across key variables at baseline, starting with descriptive examination. Where the descriptive examination suggests that one or more groups may differ substantively from the others, the statistical significance of such differences will be tested by independent sample t-tests and chi-square with alpha set at p < .05. If substantive differences are detected, these variables may be used as covariates in subsequent analyses.
A repeated measures 3 (Groups; NDBI vs ACT vs NDBI+ACT) by 3 (Time; baseline vs post-support vs follow-up) multivariate analysis of variance (MANOVA) design will be used to compare baseline scores for primary and secondary outcome measures with scores post-support, and at follow-up. Caregiver and child outcomes will be analyzed separately. Depending on the statistical significance of the MANOVA findings, post hoc procedures such as discriminant descriptive analysis (DDA) and discriminant ratio coefficients (DRC), will be used to describe the differences among groups and identify which variables contribute the most to these differences (Sajobi et al., 2019). Point-biserial correlation will be used to evaluate whether categorical variables, such as self-identified ethnicity classification and caregiver autistic/non-autistic identification, moderate any significant outcomes observed. Descriptive statistics (e.g., linear regression) will be used to examine data gathered from process variables, including the relationship between process and outcome variables and differences in process variables across groups and time.
In addition to MANOVA, within and between group differences may also be analyzed by Modified Brinley Plots, Cohen’s d (standardized mean difference) effect size with 95% Confidence Intervals, and the Percent Superiority effect size (Blampied, 2017; Lakens, 2013). The degree of clinically significant therapeutic change will be assessed by the Reliable Change Index (Jacobson & Truax, 1991). A one-way ANOVA will be performed to compare caregivers’ overall mean satisfaction with the support received across groups. Point-biserial correlation will be used to evaluate whether self-identified ethnicity classification and caregiver autistic/non-autistic identification, moderate any significant effect observed. Finally, post-support interviews will be analyzed using inductive thematic analysis.
We will conduct an intention to treat analysis, whereby multiple imputation is used to handle missing data. We will also conduct a per protocol analysis whereby participants who formally withdraw or disengage will not be included in the final comparisons. Depending on the sample size and data set of partial completers we may conduct a separate MANOVA to determine the effect of supports for this group specifically. We plan to describe the reasons for missing data, clarify whether there are meaningful differences between individuals with complete and incomplete data, and any baseline characteristics which may predict non-completion.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/08/2022
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
156
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 24954 0
New Zealand
State/province [1] 24954 0

Funding & Sponsors
Funding source category [1] 312044 0
Charities/Societies/Foundations
Name [1] 312044 0
Cure Kids
Country [1] 312044 0
New Zealand
Funding source category [2] 312049 0
Charities/Societies/Foundations
Name [2] 312049 0
A Better Start - National Science Challenge
Country [2] 312049 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Faculty of Health, University of Canterbury, Private bag 4800, Christchurch, 8041
Country
New Zealand
Secondary sponsor category [1] 313549 0
None
Name [1] 313549 0
Address [1] 313549 0
Country [1] 313549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311458 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 311458 0
Ethics committee country [1] 311458 0
New Zealand
Date submitted for ethics approval [1] 311458 0
06/06/2022
Approval date [1] 311458 0
01/08/2022
Ethics approval number [1] 311458 0
2022 FULL 12058

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121166 0
A/Prof Laurie McLay
Address 121166 0
Rehua Building Level 3, University of Canterbury, Private Bag 4800, Christchurch, 8140
Country 121166 0
New Zealand
Phone 121166 0
+64 03 369 3522
Fax 121166 0
Email 121166 0
laurie.mclay@canterbury.ac.nz
Contact person for public queries
Name 121167 0
Laurie McLay
Address 121167 0
Rehua Building Level 3, University of Canterbury, Private Bag 4800, Christchurch, 8140
Country 121167 0
New Zealand
Phone 121167 0
+64 03 369 3522
Fax 121167 0
Email 121167 0
laurie.mclay@canterbury.ac.nz
Contact person for scientific queries
Name 121168 0
Laurie McLay
Address 121168 0
Rehua Building Level 3, University of Canterbury, Private Bag 4800, Christchurch, 8140
Country 121168 0
New Zealand
Phone 121168 0
+64 03 369 3522
Fax 121168 0
Email 121168 0
laurie.mclay@canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTelehealth-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.2023https://dx.doi.org/10.1136/bmjopen-2022-071235
N.B. These documents automatically identified may not have been verified by the study sponsor.