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Trial registered on ANZCTR


Registration number
ACTRN12622001139763
Ethics application status
Approved
Date submitted
15/08/2022
Date registered
18/08/2022
Date last updated
3/11/2024
Date data sharing statement initially provided
18/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of participating in the Let's Play programme on social engagement and interaction between autistic children and their parents
Scientific title
The effect of participating in the Let's Play programme on social engagement and interaction between autistic children and their parents: A between groups, randomised controlled trial
Secondary ID [1] 307768 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 327342 0
Child social communication difficulties 327352 0
Parent stress 327353 0
Condition category
Condition code
Mental Health 324478 324478 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Let's Play programme is designed to teach caregivers the value of play and give them a repertoire of techniques they can apply in everyday routines to positively impact their child’s development. The Let's Play techniques are developed to help build children’s communication, social reciprocity, shared attention, imitation, emotion regulation, planning, and problem solving skills during caregiver-child interactions. The Let’s Play programme focuses on three target areas: (1) caregivers’ play skills, (2) caregivers’ communication strategies, and (3) the well-being of the family.

The programme draws on the Developmental Individual-Differences Relationship Model (DIR: Greenspan, 2000; Greenspan & Weider, 1999) and the Routines-Based Intervention (RBI; McWilliam, 2010; McWilliam et al., 2020), as well as Joint Action Routines (Ratner & Bruner, 1978), Vygotsky’s (1978) Zone of Proximal Development, guided participation (Rogoff, 2003), Rush and Shelden’s (2020) adult learning and coaching models, and the Maori practice of tuakana-teina (i.e., coaching of novice peers by experienced peers).

Let’s Play will be delivered by Autism New Zealand staff who designed and developed the programme, using a coaching handbook they also created. Facilitator 1 is a registered teacher in New Zealand and the United Kingdom (Bachelor of Education with Honours) and co-authored the programme. They specialise in autism and are a National Educator at Autism New Zealand. Facilitator 2 has a Bachelor of Teaching and postgraduate diplomas in Early Childhood Education and Specialist Teaching. They are part of the early intervention team at Autism New Zealand. Facilitator 3 is the parent of an autistic child. They have a Bachelor of Media Arts and experience in the publishing industry. All three have current and clean New Zealand Police vetting checks.

Each programme will include a cohort of up to 10 families. One family member will consistently attend each workshop, though additional extended family members (e.g., grandparent, family friend, etc.) are also able to attend. The programme will be delivered over a period of 9 weeks and will include three 3-hour group workshop sessions (Weeks 1, 3, and 5), five 1-hour in-home coaching visits (Weeks 2, 4, 6, 7, and 8), and an end-of-programme group celebration (Week 9).

The group workshop sessions will be conducted at the Autism New Zealand Auckland offices face-to-face; however, its structure makes it possible to deliver online if necessary (e.g., nation-wide lockdown). During in-home coaching programme facilitators will meet with caregivers in the family home to provide coaching face-to-face in the child’s natural environment. This is a single-site study. The programme is delivered at Autism New Zealand (Auckland), and the research will be conducted at the University of Canterbury (Christchurch).

Group coaching
Each group coaching session focuses on a different component of play (i.e., Group Session 1: The Basics of Play; Group Session 2: Following Your Child’s Lead; Group Session 3: Using Everyday Routines). In each session, the facilitator works through a presentation that describes: the theory behind that week’s play and/or communication techniques, examples of how the techniques can be used, exemplar videos of parents using the techniques with their autistic children, and group discussions. Each family will also be given a printed handbook that includes notes on the content covered in the group workshop sessions and reflective tasks for them to complete (e.g., a brainstorming of when and how they could utilise the techniques from the workshops with their child).

In-home visits
Before families’ participation in the programme begins, the facilitator will visit the families’ homes and introduce themselves to the family, talk to them about the programme, and film a baseline parent-child play video. During the programme home visits, facilitators will provide one-on-one guidance to the families and help them implement the techniques described during group coaching sessions. This can include facilitators discussing the achievements and challenges the family had faced that week, helping them to reflect on these experiences and providing guidance on what to try next. The family can also demonstrate how they have been using the techniques from the Let’s Play programme in-person or in a recorded video to get feedback on what they are doing well and further strategies that they could try.

Programme adherence and fidelity
Four measures will be used to ascertain parents’ levels of adherence and implementation of the Let’s Play programme’s outside of the workshops and in-home visits. First, during the programme, parents will be asked to keep a weekly log of which Let’s Play techniques they use with their child and how long (mins) they use them for each day. In this same log, they will be asked to include all of the other professional support services they have accessed to support their child’s development (e.g., speech or occupational therapy services) including the length of appointments (mins). Second, a record of the number of workshop sessions parents attend will be used a measure of support dosage. Third, the 10-minute parent-child interaction videos will be used to assess parents’ implementation of the workshop modules when with their child. One 10-minute parent-child interaction video will be provided at baseline, immediately post-participation, and at 6-month follow-up. And fourth, an independent observer will use a checklist to assess whether the Let’s Play Programme was implemented with fidelity, for at least 15% of the workshop sessions and home visits. This will ensure that the programme is being administered as laid out in the coaching handbook and, hence, participants are receiving the same service.
Intervention code [1] 324236 0
Treatment: Other
Intervention code [2] 324237 0
Behaviour
Comparator / control treatment
The control participants will not have access to the Let’s Play programme materials while they are on the waitlist. The duration of their wait will be 9 weeks (the length of the programme). Once the waitlist controls finish their wait period, they will be invited to take part in the Let’s Play programme. If they choose to take part, they will be scheduled into the next available cohort. Waitlist controls will be asked to keep a log of the standard care support services (e.g., speech therapist appointment) they and their child access each month that they are on the waitlist.
Control group
Active

Outcomes
Primary outcome [1] 332297 0
Changes in children's engagement with their parent - coded from filmed 10-minute parent-child play interactions using Bakeman and Adamson's (1984) method
Timepoint [1] 332297 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10, primary timepoint), and at 6-month follow-up (Time 3; Week 35)
Primary outcome [2] 332298 0
Changes in parent's mean stress scores using the self-report Parenting Stress Index (Fourth Edition, Short Form; PSI-4-SF; Abidin, 2012)
Timepoint [2] 332298 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10, primary timepoint), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [1] 412870 0
Changes in parent's mean mental health scores using the self-report Depression, Anxiety, and Stress Scale (DASS-21; Henry & Crawford, 2005)
Timepoint [1] 412870 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [2] 412871 0
Changes in parent's mean parenting self-efficacy scores on the self-report Parent Sense of Competence Scale (PSOC; Johnston & Mash, 1989)
Timepoint [2] 412871 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [3] 412872 0
Changes in children's mean social responsiveness scores using the parent-report Social Responsiveness Scale (Second Edition Preschool Form; SRS-2; Constantino & Gruber, 2012)
Timepoint [3] 412872 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [4] 412873 0
Changes in children's mean quality of life scores using the parent-report Generic Core Scales of the Pediatric Quality of Life Inventory (PedsQL; Varni et al., 2001; Varni et al., 1999)
Timepoint [4] 412873 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [5] 412874 0
Changes in children's mean behaviour scores on the parent-report Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Timepoint [5] 412874 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [6] 412875 0
Changes in children's mean communication using the Systematic Analysis of Language Transcripts software (Version 20, New Zealand/Australia; SALT-NZAU; Miller et al., 1992) to code their filmed 10-minute parent-child interaction videos
Timepoint [6] 412875 0
Measured at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [7] 412876 0
Parent ratings of the social validity of the Let's Play programme using the revised Treatment Acceptability Rating Form (TARF-R; Reimers et al., 1992)
Timepoint [7] 412876 0
Completed once post-participation (Time 2; Week 10)
Secondary outcome [8] 412877 0
Semi-structured interviews with parents about the Let's Play programme, including topics such as cultural acceptability, method of programme delivery and content; enablers and barriers to supports; and suggestions for improvement. These interviews will be conducted by a member of the research team, in-person or via phone call depending on each participating family's preference.
Timepoint [8] 412877 0
Completed once post-participation (Time 2; Week 10)
Secondary outcome [9] 412878 0
Parents' adherence to using the Let's Play programme techniques with their child using a weekly log of which techniques they used with their child and how long (mins) they used each for
Timepoint [9] 412878 0
Measured each day of Weeks 1 through 9 while they are in the programme
Secondary outcome [10] 412879 0
Support dosage measured as the number of group workshop sessions the parents attend (out of 3)
Timepoint [10] 412879 0
Recorded throughout the programme (Weeks 1 through 9)
Secondary outcome [11] 412880 0
Parents' implementation of the Let's Play programme techniques when interacting with their child coded from the 10-minute parent-child interaction videos
Timepoint [11] 412880 0
Coded from the three time point parent-child interaction videos filmed at baseline (Time 1; Week 0), immediately post-participation (Time 2; Week 10), and at 6-month follow-up (Time 3; Week 35)
Secondary outcome [12] 412881 0
An independent observer will use a checklist to assess whether the Let’s Play Programme was implemented with fidelity for at least 15% of the workshop sessions and home visits
Timepoint [12] 412881 0
This will be observed and measured during the programme's delivery (Weeks 1 through 9)

Eligibility
Key inclusion criteria
(1) have a child who is autistic or who has been identified as needing further diagnostic assessment.
(2) their child is aged between 0 and 5 years 11 months.
(3) the caregiver consents to randomisation (i.e., accept that they may be put on the waitlist).
(4) the caregiver consents to participating in the evaluation of the Let’s Play programme (i.e., contributing data).
Minimum age
0 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) they are taking part in another parenting programme or receiving more than 15 hours of support per week through another service.
(2) the caregiver does not speak sufficient English to be able to understand the consent processes and participate in the workshop sessions.
(3) another child from their family is already participating in the trial.

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)
The allocation order will be conducted by an independent statistician (see below). They will provide this allocation order to a research assistant also outside of the research team, who will copy the allocation order into numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated fixed block size randomization with an allocation ratio of 1:1 and block size of 4, will generate a random allocation order stratified by ethnicity (participants who self-identify as Maori or non-Maori). A statistician outside of the research team will be engaged to generate this allocation order.
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
Power calculation
An a priori, two-tailed power calculation was conducted to estimate sample size using G*Power software (version 3.1.9.6; Faul et al., 2009; Faul et al., 2007). The power calculation suggested a minimum of 52 families will be needed to detect a medium-sized effect (d = 0.80; a = 0.05; power = 0.80). To account for 20% attrition this was increased to 64 families (i.e., 32 families per condition). With 10 families participating in each Let’s Play programme cohort, this is akin to 3 cohorts, thus, a minimum of 3 cohorts will be run.

This power calculation was done based on the primary child outcome measure (i.e., the child’s level of engagement in caregiver/child interactions) using Bakeman and Adamson’s (1984) coding method (i.e., calculating the proportion of time the child spent engaged in coordinated joint attention with their caregiver from caregiver/child play videos). While the error and power rates are standard, the effect size was based off of Kasari et al. (2010) who reported a strong effect of JASPER (another Naturalistic Developmental Behavioural Intervention) participation on increasing children’s joint attention (Cohen's d = 0.87).

Statistical analyses
The CONSORT (Moher et al., 2010; Schulz et al., 2010) and SPIRIT (Chan, Tetzlaff, Altman et al., 2013; Chan, Tetzlaff, Gøtzsche et al., 2013) statements and associated guidelines will be consulted in the reporting of the results. The two treatment groups will be compared for equivalency across key variables at baseline, starting with descriptive examination of the key variables. 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 2 (Groups; Let’s Play vs WLC) 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. The regression diagnostics and model assumptions will be checked. Caregiver and child outcomes will be analysed separately. Self-identified parent and child ethnicity classifications and whether parents are autistic will be included as separate factors to evaluate the current model of service delivery and support for Maori versus non-Maori, and autistic versus non-autistic whanau.

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. 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 analysed by Modified Brinley Plots, Cohen’s d (standardized mean difference) ES with 95% Confidence Intervals, and the Percent Superiority ES (Blampied, 2017). The degree of clinically significant therapeutic change will be assessed by the Reliable Change Index (Jacobson & Truax, 1991). An independent sample t-test will be performed to compare caregivers’ overall satisfaction with the support received across groups and by ethnicity classification and caregiver neurotype. Finally, post-support interviews will be analysed using inductive thematic analysis. Instead of doing a formal thematic analysis, we will examine post-participation caregiver interview data for themes.

We will conduct and report intention to treat, per protocol (whereby participants who formally withdraw or disengage will not be included in the final comparisons), and sensitivity analyses (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
Completed
Date of first participant enrolment
Anticipated
5/09/2022
Actual
13/10/2022
Date of last participant enrolment
Anticipated
20/03/2023
Actual
13/06/2023
Date of last data collection
Anticipated
19/05/2024
Actual
23/05/2024
Sample size
Target
128
Accrual to date
Final
182
Recruitment outside Australia
Country [1] 24953 0
New Zealand
State/province [1] 24953 0

Funding & Sponsors
Funding source category [1] 312038 0
Charities/Societies/Foundations
Name [1] 312038 0
Laura Fergusson Trust
Country [1] 312038 0
New Zealand
Funding source category [2] 312046 0
Charities/Societies/Foundations
Name [2] 312046 0
Joyce Fisher Endowment Fund Trust
Country [2] 312046 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Cathy Andrew
Address
Faculty of Health, University of Canterbury, Private bag 4800, Christchurch, 8041
Country
New Zealand
Secondary sponsor category [1] 313541 0
None
Name [1] 313541 0
Address [1] 313541 0
Country [1] 313541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311454 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 311454 0
Ethics committee country [1] 311454 0
New Zealand
Date submitted for ethics approval [1] 311454 0
10/08/2022
Approval date [1] 311454 0
06/10/2022
Ethics approval number [1] 311454 0
2022 FULL 13041

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

Contacts
Principal investigator
Name 121150 0
A/Prof Laurie McLay
Address 121150 0
Faculty of Health
University of Canterbury
Private bag 4800
Christchurch 8140
Country 121150 0
New Zealand
Phone 121150 0
+64 03 369 3522
Fax 121150 0
Email 121150 0
laurie.mclay@canterbury.ac.nz
Contact person for public queries
Name 121151 0
Laurie McLay
Address 121151 0
Faculty of Health
University of Canterbury
Private bag 4800
Christchurch 8140
Country 121151 0
New Zealand
Phone 121151 0
+64 03 369 3522
Fax 121151 0
Email 121151 0
laurie.mclay@canterbury.ac.nz
Contact person for scientific queries
Name 121152 0
Laurie McLay
Address 121152 0
Faculty of Health
University of Canterbury
Private bag 4800
Christchurch 8140
Country 121152 0
New Zealand
Phone 121152 0
+64 03 369 3522
Fax 121152 0
Email 121152 0
laurie.mclay@canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be made available to other researchers on request for future research as specified in the data management plan. In all cases, the co-ordinating investigator must be satisfied that appropriate Data Management Plans are in place and that ethical approval for use has been obtained in accordance with local laws and regulations.

De-identified data may be used for future medical or scientific research as specified below:
- unspecified purposes which are directly related to the study question(s).
- unspecified purposes which are related to the item and/or condition under study.
- unspecified medical or scientific purposes which are not related to the study questions.
When will data be available (start and end dates)?
Start date - October 2024
End data - October 2034
Available to whom?
De-identified data may be accessed and used by the following groups:
• The Investigator and suitably trained and experienced study staff, to conduct the study.
• The study co-sponsors may access aggregated and analysed data.
? The Health and Disability Ethics Committee, to comply with legal and regulatory duties.
? Health, regulatory, or government authorities, to comply with legal and regulatory duties.
De-identified data may be included in published study results including, but not limited to, peer-reviewed publications, clinical trial registry websites, scientific meetings, and regulatory / marketing submissions.
De-identified data may be included in clinical trial registries and data banks.
Available for what types of analyses?
De-identified data may be used for future medical or scientific research as specified below:
- unspecified purposes which are directly related to the study question(s).
- unspecified purposes which are related to the item and/or condition under study.
- unspecified medical or scientific purposes which are not related to the study questions.
If participants provide optional additional consent, de-identified data will be made available to other researchers on request for future research as specified above and / or will be added to data from other sources to form larger datasets.
In all cases, the co-ordinating investigator must be satisfied that appropriate Data Management Plans are in place and that ethical approval for use has been obtained in accordance with local laws and regulations.
De-identified data may be sent overseas to investigators for individual participant data meta-analysis.
How or where can data be obtained?
De-identified individual participant data that underlie published results may be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for individual participant data meta-analysis immediately following publication and ending 10 years after publication.
Data can be be made available by emailing the principal investigator - laurie.mclay@canterbury.ac.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24292Other    384523-(Uploaded-24-10-2024-07-51-05)-Data Management Plan.pdf



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