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Trial registered on ANZCTR


Registration number
ACTRN12623000806662
Ethics application status
Approved
Date submitted
28/06/2023
Date registered
27/07/2023
Date last updated
18/09/2023
Date data sharing statement initially provided
27/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial (RCT) study of a parent support program for parents of autistic children
Scientific title
A pilot randomised controlled trial (RCT) study of a parent support program for parents of autistic children
Secondary ID [1] 309920 0
None
Universal Trial Number (UTN)
U1111-1293-9661
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health of parents of autistic children 330396 0
Quality of life of parents of autistic children 330397 0
Mental health of autistic children 330398 0
Parental well-being of parents of autistic children 330399 0
Condition category
Condition code
Mental Health 327234 327234 0 0
Autistic spectrum disorders
Mental Health 327235 327235 0 0
Anxiety
Mental Health 327236 327236 0 0
Depression
Mental Health 327237 327237 0 0
Other mental health disorders
Public Health 327238 327238 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents in the intervention group will commence a 5-week online group program (one 2-hour group session per week) aimed at developing parental insightfulness, parental acceptance, and understanding of autistic children (10 years and younger). Participants are allocated to online groups (approximately 3-5 parents) where they will cover the following topics over the 5 weeks: Psychoeducation about autism grounded in the social disability model and neurodiversity affirming paradigm, values-based parenting, parent-child attachment relationship, parental acceptance as a gateway to child acceptance, mindfulness, psychological flexibility, self-compassion. Activities such as mindful reflection of their own attachment history and how it applies to their current parenting and child-focused mindfulness and acceptance exercises will be engaged in. Sessions are facilitated by a registered clinical psychologist. Participants attendance will also be recorded as part of intervention adherence monitoring.
Intervention code [1] 326351 0
Lifestyle
Intervention code [2] 326352 0
Behaviour
Intervention code [3] 326353 0
Treatment: Other
Comparator / control treatment
The control group will be a "waitlist control" group; that is no active intervention will be made available to these participants. The control group will have their usual support and access to primary care providers. Following the completion of the final assessments, all participants in the "waitlist control" group will be offered access to the online group program.
Control group
Active

Outcomes
Primary outcome [1] 335120 0
Parental sensitivity as assessed by the Emotional Availability (EA) Scales
Timepoint [1] 335120 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Primary outcome [2] 335121 0
Parent-reported child responsiveness and child involvement toward their caregiver as assessed by the Emotional Availability (EA) Scales and Emotional Availability Self-Report (EA-SR)
Timepoint [2] 335121 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [1] 423117 0
Parental acceptance and understanding of their autistic child as assessed by the Parental Acceptance and Understanding of Autistic Children Scale (PAUACS)
Timepoint [1] 423117 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [2] 423118 0
Parental psychological flexibility as assessed by the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
Timepoint [2] 423118 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [3] 423119 0
Mindful parenting as assessed by the Bangor Parenting Mindful Parenting Scale (BMPS)
Timepoint [3] 423119 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [4] 423120 0
Parental psychological adjustment as assessed by the Depression, Anxiety, Stress Scales (DASS-21)
Timepoint [4] 423120 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [5] 423121 0
Parent-reported child behavioural difficulties as assessed by the Strengths and Difficulties Questionnaire (SDQ)
Timepoint [5] 423121 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [6] 423122 0
Parent reported child behavioural flexibility as assessed by the Behaviour Flexibility Rating Scale – Revised (BFRS-R)
Timepoint [6] 423122 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [7] 423123 0
Parent-reported child adaptive functioning as assessed by the Autism Family Experience Questionnaire (AFEQ)
Timepoint [7] 423123 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [8] 423124 0
Parental quality of life as assessed by the Quality of Life in Autism Questionnaire (QoLA)
Timepoint [8] 423124 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [9] 423125 0
Goal attainment as assessed by the Goal Attainment Scale (GAS)
Timepoint [9] 423125 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [10] 423126 0
Feasibility of the program as assessed via recruitment rates. This will be determined via audit of study enrolment and withdrawal logs detailing participants' intervention completion and participant retention.
Timepoint [10] 423126 0
Immediately post-intervention completion
Secondary outcome [11] 423508 0
Acceptability of the program as assessed via participant feedback survey which was designed specifically for the study.
Timepoint [11] 423508 0
Immediately post-intervention completion
Secondary outcome [12] 423929 0
Parental mental health as assessed by the Autism Family Experience Questionnaire (AFEQ).
Timepoint [12] 423929 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [13] 423930 0
Parental wellbeing as assessed by the Autism Family Experience Questionnaire (AFEQ).
Timepoint [13] 423930 0
Baseline, immediately post intervention completion and 3-months post intervention completion
Secondary outcome [14] 424315 0
Feasibility of the program as assessed via attendance rates as determined by study logs.
Timepoint [14] 424315 0
Immediately post-intervention completion
Secondary outcome [15] 424316 0
Feasibility of the program as assessed via qualitative feedback as per open-ended questions in the participant feedback survey developed specifically for the study.
Timepoint [15] 424316 0
Immediately post-intervention completion and 3-months post intervention completion.

Eligibility
Key inclusion criteria
Participants will be parents of autistic children (10 years and younger) living in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed (randomisation by REDcap during baseline assessment).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by computer software (REDcap will randomly allocate participants to intervention or waitlist control)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To obtain a minimum of 90% power, 5% two-tailed significance and a medium effect size (Cohen’s d = 0.5) for the primary outcomes, based on recommendations for powering pilot studies from Whitehead et al. (2016), it is estimated that approximately 38 parents of autistic children (aged 10 and younger) (19 participants per arm [Intervention vs Waitlist Control]) will be required . This sample size also includes allowance for 20% potential attrition. Participants will be randomised to either waitlist control or the parent support program delivered by a registered psychologist. Assessments will occur at baseline (T1), after the program (T2), and at 3-months follow up (T3).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
4/09/2023
Date of last participant enrolment
Anticipated
1/11/2023
Actual
Date of last data collection
Anticipated
29/03/2024
Actual
Sample size
Target
38
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314103 0
University
Name [1] 314103 0
The University of Queensland Graduate School
Country [1] 314103 0
Australia
Primary sponsor type
Individual
Name
Jia Ying Sarah Lee
Address
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 316020 0
None
Name [1] 316020 0
Address [1] 316020 0
Country [1] 316020 0
Other collaborator category [1] 282703 0
Individual
Name [1] 282703 0
Dr Koa Whittingham
Address [1] 282703 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country [1] 282703 0
Australia
Other collaborator category [2] 282704 0
Individual
Name [2] 282704 0
Dr Amy Mitchell
Address [2] 282704 0
School of Nursing, Midwifery and Social Work, Level 3, Chamberlain Building (35)
The University of Queensland, St Lucia QLD 4072 Australia
Country [2] 282704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313243 0
The University of Queensland Human Research Ethics Committees (HRECs)
Ethics committee address [1] 313243 0
Ethics committee country [1] 313243 0
Australia
Date submitted for ethics approval [1] 313243 0
05/06/2023
Approval date [1] 313243 0
10/08/2023
Ethics approval number [1] 313243 0
2023/HE000414

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

Contacts
Principal investigator
Name 127454 0
Ms Jia Ying Sarah Lee
Address 127454 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 127454 0
Australia
Phone 127454 0
+61 7 3069 7358
Fax 127454 0
Email 127454 0
lee.jy.sarah@uq.net.au
Contact person for public queries
Name 127455 0
Jia Ying Sarah Lee
Address 127455 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 127455 0
Australia
Phone 127455 0
+61 7 3069 7358
Fax 127455 0
Email 127455 0
lee.jy.sarah@uq.net.au
Contact person for scientific queries
Name 127456 0
Jia Ying Sarah Lee
Address 127456 0
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
Country 127456 0
Australia
Phone 127456 0
+61 7 3069 7358
Fax 127456 0
Email 127456 0
lee.jy.sarah@uq.net.au

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
No additional documents have been identified.