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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
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Scientific title
A pilot randomised controlled trial (RCT) study of a parent support program for parents of autistic children
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Secondary ID [1]
309920
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None
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Universal Trial Number (UTN)
U1111-1293-9661
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental health of parents of autistic children
330396
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Quality of life of parents of autistic children
330397
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Mental health of autistic children
330398
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Parental well-being of parents of autistic children
330399
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Condition category
Condition code
Mental Health
327234
327234
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0
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Autistic spectrum disorders
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Mental Health
327235
327235
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0
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Anxiety
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Mental Health
327236
327236
0
0
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Depression
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Mental Health
327237
327237
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0
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Other mental health disorders
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Public Health
327238
327238
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326351
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Lifestyle
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Intervention code [2]
326352
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Behaviour
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Intervention code [3]
326353
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Parental sensitivity as assessed by the Emotional Availability (EA) Scales
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Assessment method [1]
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Timepoint [1]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Primary outcome [2]
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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)
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Assessment method [2]
335121
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Timepoint [2]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [1]
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Parental acceptance and understanding of their autistic child as assessed by the Parental Acceptance and Understanding of Autistic Children Scale (PAUACS)
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Assessment method [1]
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Timepoint [1]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [2]
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Parental psychological flexibility as assessed by the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
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Assessment method [2]
423118
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Timepoint [2]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [3]
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Mindful parenting as assessed by the Bangor Parenting Mindful Parenting Scale (BMPS)
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Assessment method [3]
423119
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Timepoint [3]
423119
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [4]
423120
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Parental psychological adjustment as assessed by the Depression, Anxiety, Stress Scales (DASS-21)
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Assessment method [4]
423120
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Timepoint [4]
423120
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [5]
423121
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Parent-reported child behavioural difficulties as assessed by the Strengths and Difficulties Questionnaire (SDQ)
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Assessment method [5]
423121
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Timepoint [5]
423121
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [6]
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Parent reported child behavioural flexibility as assessed by the Behaviour Flexibility Rating Scale – Revised (BFRS-R)
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Assessment method [6]
423122
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Timepoint [6]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [7]
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Parent-reported child adaptive functioning as assessed by the Autism Family Experience Questionnaire (AFEQ)
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Assessment method [7]
423123
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Timepoint [7]
423123
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [8]
423124
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Parental quality of life as assessed by the Quality of Life in Autism Questionnaire (QoLA)
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Assessment method [8]
423124
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Timepoint [8]
423124
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [9]
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Goal attainment as assessed by the Goal Attainment Scale (GAS)
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Assessment method [9]
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Timepoint [9]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [10]
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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.
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Assessment method [10]
423126
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Timepoint [10]
423126
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Immediately post-intervention completion
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Secondary outcome [11]
423508
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Acceptability of the program as assessed via participant feedback survey which was designed specifically for the study.
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Assessment method [11]
423508
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Timepoint [11]
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Immediately post-intervention completion
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Secondary outcome [12]
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Parental mental health as assessed by the Autism Family Experience Questionnaire (AFEQ).
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Assessment method [12]
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Timepoint [12]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [13]
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Parental wellbeing as assessed by the Autism Family Experience Questionnaire (AFEQ).
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Assessment method [13]
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Timepoint [13]
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Baseline, immediately post intervention completion and 3-months post intervention completion
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Secondary outcome [14]
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Feasibility of the program as assessed via attendance rates as determined by study logs.
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Assessment method [14]
424315
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Timepoint [14]
424315
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Immediately post-intervention completion
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Secondary outcome [15]
424316
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Feasibility of the program as assessed via qualitative feedback as per open-ended questions in the participant feedback survey developed specifically for the study.
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Assessment method [15]
424316
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Timepoint [15]
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Immediately post-intervention completion and 3-months post intervention completion.
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Eligibility
Key inclusion criteria
Participants will be parents of autistic children (10 years and younger) living in Australia.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed (randomisation by REDcap during baseline assessment).
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/08/2023
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Actual
4/09/2023
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Date of last participant enrolment
Anticipated
1/11/2023
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Actual
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Date of last data collection
Anticipated
29/03/2024
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Actual
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Sample size
Target
38
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Accrual to date
5
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
314103
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University
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Name [1]
314103
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The University of Queensland Graduate School
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Address [1]
314103
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Level 6, John Hines Building (62)
The University of Queensland
St Lucia QLD 4072, Australia
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Country [1]
314103
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Australia
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Primary sponsor type
Individual
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Name
Jia Ying Sarah Lee
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Address
Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
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Country
Australia
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Secondary sponsor category [1]
316020
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None
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Name [1]
316020
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Address [1]
316020
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Country [1]
316020
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Other collaborator category [1]
282703
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Individual
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Name [1]
282703
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Dr Koa Whittingham
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Address [1]
282703
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Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
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Country [1]
282703
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Australia
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Other collaborator category [2]
282704
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Individual
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Name [2]
282704
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Dr Amy Mitchell
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Address [2]
282704
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School of Nursing, Midwifery and Social Work, Level 3, Chamberlain Building (35)
The University of Queensland, St Lucia QLD 4072 Australia
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Country [2]
282704
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313243
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The University of Queensland Human Research Ethics Committees (HRECs)
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Ethics committee address [1]
313243
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UQ Research & Innovation
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia
QLD 4072
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Ethics committee country [1]
313243
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Australia
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Date submitted for ethics approval [1]
313243
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05/06/2023
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Approval date [1]
313243
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10/08/2023
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Ethics approval number [1]
313243
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2023/HE000414
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Summary
Brief summary
Parental acceptance and insightfulness has been found to be important to the attachment security and social and emotional development of autistic children. However, no research exists relating to developing parental insightfulness and acceptance in parents of autistic children. This study tests the effectiveness, feasibility and acceptability of a novel consumer-informed parent support program through a pilot randomised controlled trial (RCT) of the AutInsight program: a program developed based on insights from autistic adults and what they wanted from their own parents. The program seeks to help parents i) develop greater insight and understanding of autism from the inside out, drawing on the perspectives of autistic adults; ii) strengthen their relationship with their child; and iii) develop practical strategies for parents’ self-care. It is expected that at the end of the program, parents will develop in insightfulness and acceptance of their autistic children, report a better relationship with their child as well as develop greater strategies for self-care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Jia Ying Sarah Lee
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Address
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Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
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Country
127454
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Australia
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Phone
127454
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+61 7 3069 7358
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Fax
127454
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Email
127454
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[email protected]
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Contact person for public queries
Name
127455
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Ms Jia Ying Sarah Lee
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Address
127455
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Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
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Country
127455
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Australia
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Phone
127455
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+61 7 3069 7358
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Fax
127455
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Email
127455
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[email protected]
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Contact person for scientific queries
Name
127456
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Ms Jia Ying Sarah Lee
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Address
127456
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Centre for Children’s Health Research, 62 Graham Street, South Brisbane, QLD 4101
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Country
127456
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Australia
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Phone
127456
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+61 7 3069 7358
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Fax
127456
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Email
127456
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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