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Trial registered on ANZCTR


Registration number
ACTRN12624000394549
Ethics application status
Approved
Date submitted
26/02/2024
Date registered
3/04/2024
Date last updated
5/11/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability, feasibility, and short-term effects of a coach-supported, online parenting program (‘PiP Kids-Autism’) for parents of autistic children, targeting child depression and anxiety.
Scientific title
An open-label, uncontrolled feasibility and acceptability trial of a therapist-assisted, online parenting program (‘PiP Kids-Autism’) for parents of autistic children, targeting child depression and anxiety.
Secondary ID [1] 311355 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting practices of parents of autistic children 332618 0
Autistic Child Depression 332619 0
Autistic Child Anxiety 332620 0
Condition category
Condition code
Public Health 329322 329322 0 0
Health promotion/education
Public Health 329323 329323 0 0
Health service research
Mental Health 329324 329324 0 0
Depression
Mental Health 329325 329325 0 0
Anxiety
Mental Health 329927 329927 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, ‘Partners in Parenting-Kids Autism’ (PiP Kids-Autism), is an adapted version of the web-based parenting program ‘Parenting Resilient Kids’ (PaRK; ACTRN12616000621415), since renamed 'PiP Kids'. The original PaRK program is an online parenting program designed to equip parents with evidence-based parenting guidelines to respond to anxiety or depression in their child. PiP Kids-Autism has been adapted to empower parents to prevent or reduce depression and anxiety in their autistic child.

The PiP Kids-Autism intervention has two components:
1) a web-based program drawn from the PaRK intervention, which includes a parenting self-assessment with tailored feedback about the parent's current parenting practices, and up to 15 web-based modules; and
2) a coaching component delivered via videoconference, henceforth referred to as ‘coaching sessions’.

The web-based program includes 15 self-directed online modules covering topics related to parenting an autistic child in the context of reducing the child's anxiety and/or depression, which parents are recommended based on their responses to the self-assessment parenting scale and their own preferences/interests.

Modules are based on a range of information including topics such as Autism fundamentals, managing behaviours and emotions, showing affection, setting family rules, managing conflict, managing internalising behaviours, setting goals and when to seek help.

The coaching component involves parents attending up to 8 sessions, of which the first includes an orientation component before educational materials. The coaching will be held with a PiP coach via videoconference. The aim of the orientation component is to discuss the program objectives and boundaries with the parent and build rapport. PiP coaches are provisional psychologists completing a PhD (Clinical Psychology) or Master of Clinical Psychology at Monash University. All coaches will receive an intensive training program which will include online learning materials and live and/or recorded role-play exercises with feedback. Additionally, coaches will be provided with ongoing support and development through regular supervision with a registered senior psychologist who is a Board-approved supervisor by the Psychology Board of Australia. The initial coaching session will take up to 90 minutes to allow enough time for coaches to gain a good understanding about the child and parents needs. All other coaching sessions will take approximately 50-60 minutes. Parents will complete coaching sessions weekly. Coaching sessions are manualised to ensure standardised delivery of the intervention.

Parents will receive the following as part of the PiP Kids-Autism intervention:
1) Parents first complete two online self-assessments of their parenting practices which will take approximately 25 minutes to complete (The Parenting to Reduce Child Anxiety and Depression Scale - Autism; PaRCADS-Autism and the Parent Self Efficacy Scale - Autism; PSES-A). The original PaRCADS was developed as a criterion-referenced measure to assess parenting against a set of evidence-based parenting guidelines for the prevention of child anxiety and depressive disorders (Sim et al., 2019). The PaRCADS-Autism has been adapted specifically for use with parents of autistic children. Parents will rate their own parenting practices on domains such as their involvement in their child's life, how they manage conflict and how they help their child manage emotions. Responses will be rated on a 5-point likert scale ranging from 'almost never' to 'almost always'. The original PSES measures parental self-efficacy in parenting to reduce the risk of adolescent depression and anxiety (see Nicolas et al, 2020). The PSES-Autism has been adapted specifically for use with parents of autistic children to measure parents' confidence in parenting to reduce the risk of depression and anxiety in their autistic child. Responses will be rated on a 4-point likert scale ranging from 'not at all confident' to 'very confident'.

2) Based on parents’ responses to the PaRCADS-Autism, parents receive an individually-tailored feedback report. The feedback highlights areas of parenting strength and/or confidence, and provides practical strategies for identified areas for further development. The feedback report is displayed to parents online via their 'personal dashboard' as part of the program.

3) Parents will receive at least 6 core compulsory modules and in addition are recommended up to 9 other interactive online modules (a total maximum of 15 modules). Besides the core modules, all recommended modules will be based on each parent’s identified areas for further development (PaRCADS-Autism & PSES-A scores), but will remain optional.

The modules provide practical strategies to support parents to make changes to their parenting to align more closely with the parenting recommendations in the evidence-based and expert-consensus-based Parenting Guidelines, and evidence-based content curated to support parents in reducing depression and anxiety in their autistic child. Parents can tailor their program by selecting additional modules, as well as those recommended to them. Parents will also be able to de-select recommended modules if they choose. A total of 15 online modules will be available to add to their personalised program. By default, modules will ‘unlock’ (i.e. become available for parents to complete) at a rate of one module per week, until all selected modules have been unlocked. Parents are notified by email and SMS (if they opt in to SMS notifications) when a new module unlocks. If they prefer, parents can choose to override the default unlock date, and unlock modules at an earlier date. After all initial core and recommended modules have been unlocked, all remaining modules, including those not initially recommended, will become available for parents to complete if they wish. Parents can revisit any modules they have already completed at any time.

The interactive modules can be accessed online, from any device with internet access (including smartphones). The modules include educational materials, illustrations, audio clips, videos, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. Each module takes approximately 30 minutes to complete, depending on the topic and how parents engage with the module. Parents are invited to complete their first module immediately after they have completed their baseline survey, received their personalised feedback report and selected their modules for the program.

4) Parents will receive coaching sessions with a PiP coach via video-conference approximately weekly whilst completing the modules. Parents have up to 12 weeks to complete a maximum of 8 coaching sessions.

In each session, parents will be guided by their coach through a check-in, a review of the online-module content, completion of an activity, and a goal-setting exercise, with a view to work towards their selected goal between sessions. Post-session, parents will have access to a collaborative coach-parent document, akin to a guided reflection/learning record.

Intervention adherence will be monitored through website analytics (module completion) and attendance records (coaching sessions). The intervention period is anticipated to run for up to 15 weeks.

Note. Children will not be directly involved in the intervention or coaching sessions.
Intervention code [1] 327802 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337143 0
Change in preventive parenting practices (core) from pre to post intervention (quantitative).
Timepoint [1] 337143 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date
Primary outcome [2] 339807 0
Change in parenting efficacy from pre to post intervention (quantitative).
Timepoint [2] 339807 0
Primary outcome [3] 339808 0
Change in parenting efficacy from pre to post intervention (quantitative).
Timepoint [3] 339808 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [1] 430863 0
Change in parent-reported child internalising symptoms from pre to post intervention (quantitative).
Timepoint [1] 430863 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [2] 430864 0
Change in parent-reported child externalising symptoms from pre to post intervention (quantitative).
Timepoint [2] 430864 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [3] 430866 0
Change in parent reported child emotion dysregulation (quantitative).
Timepoint [3] 430866 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [4] 430867 0
Change in parent reported child participation (home, school and community settings) (quantitative).
Timepoint [4] 430867 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [5] 430868 0
Change in parent reported parent mental health (quantitative).
Timepoint [5] 430868 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [6] 430870 0
Parental intervention satisfaction (quantitative).
Timepoint [6] 430870 0
1) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [7] 430917 0
Overall program adherence (quantitative).
Timepoint [7] 430917 0
1) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [8] 431519 0
Parental intervention engagement: e-modules (quantitative).
Timepoint [8] 431519 0
1) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [9] 431521 0
Parental intervention engagement: coaching sessions (quantitative).
Timepoint [9] 431521 0
Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [10] 431611 0
Intervention and coaching acceptability and feasibility (qualitative).
Timepoint [10] 431611 0
Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [11] 432853 0
Change in parent reported child emotion dysregulation (quantitative).
Timepoint [11] 432853 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [12] 441434 0
Change in parent-reported child sleep problem symptoms from pre to post intervention (quantitative).
Timepoint [12] 441434 0
Secondary outcome [13] 441435 0
Change in parent-reported child sleep problem symptoms from pre to post intervention (quantitative).
Timepoint [13] 441435 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [14] 441436 0
Change in the parent-reported interference, of child sleep problem symptoms, on daily functioning.
Timepoint [14] 441436 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [15] 441437 0
Change in the parent-reported interference, of child sleep problem symptoms, on daily functioning.
Timepoint [15] 441437 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [16] 441438 0
Change in preventive parenting practices (non core) from pre to post intervention (quantitative).
Timepoint [16] 441438 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 120 days from baseline assessment completion date
Secondary outcome [17] 441439 0
Change in preventive parenting practices (non core) from pre to post intervention (quantitative).
Timepoint [17] 441439 0
1) Pre-intervention (baseline survey package)
2) Post-intervention: 120 days from baseline assessment completion date

Eligibility
Key inclusion criteria
Parents/guardians:
- of autistic children aged 8 - 11 who live in Australia
- who can read and speak English
- have internet access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Child does not yet have phrase speech (meaningful multi-word utterances that include an action word such as "I am jumping on the trampoline").
2. Child has a significant neurologic or metabolic disorder, chromosomal abnormality, motor or sensory impairment, or a life-threatening medical condition.
3. Child requires acute treatment or intensive intervention (i.e. behaviours that have resulted in physical injuries to self or others requiring emergency care services more than once in the last 4 months, and/or ongoing behaviours that require ambulance/hospital/police contact).
4. Child is currently taking medication for anxiety or depression.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis and sample size calculations:
In the PaRK universal prevention RCT, we found small effect sizes for the co-primary outcomes of preventive parenting practices measured using the PaRCADS & parenting efficacy measured using the PSES-A (d(postintervention)=0.27; d(12month)=0.24). The absence of effect size estimates on a selective/indicated-prevention parenting-specific outcome for internalising problems in autistic children precludes a precise calculation of the required sample size. In a separate trial of another coach-supported online parenting intervention by the research team, we obtained a very large effect size at post-intervention (d=1.16). Conservatively, we estimate that N=34 parents would provide 80% power to detect a medium effect size (d=0.5) for our co-primary outcomes of preventive parenting practices (PaRCADS-Autism) & parenting efficacy (PSES-A), with a d=0.5 and pre-post correlations=.5 in a two-tailed paired samples t-test. To allow for 30% attrition, we will recruit 45 parents.

Statistical Analysis Plan:
To assess short-term effects of the quantitative co-primary outcomes (preventive parenting practices & parenting efficacy) and secondary outcomes (child internalising and externalising symptoms, child emotion dysregulation, parent mental health, intervention satisfaction, intervention e-module engagement, intervention coaching session engagement, overall program adherence, child sleep problems, child sleep problem interference on daily functioning), paired samples t-tests will be conducted for each outcome measure.

To assess the qualitative secondary outcome (program acceptability and feasibility) thematic analysis will be conducted on data collected via semi structured interviews.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
8/10/2024
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
26/12/2025
Actual
Sample size
Target
45
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315611 0
Charities/Societies/Foundations
Name [1] 315611 0
Australian Rotary Health
Country [1] 315611 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country
Australia
Secondary sponsor category [1] 317728 0
None
Name [1] 317728 0
Address [1] 317728 0
Country [1] 317728 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314499 0
Monash University Human Research Ethics Comittee
Ethics committee address [1] 314499 0
Ethics committee country [1] 314499 0
Australia
Date submitted for ethics approval [1] 314499 0
08/01/2024
Approval date [1] 314499 0
05/02/2024
Ethics approval number [1] 314499 0
40824

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

Contacts
Principal investigator
Name 131802 0
Prof Marie Yap
Address 131802 0
School of Psychological Sciences, Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
Country 131802 0
Australia
Phone 131802 0
+61 03 9905 1250
Fax 131802 0
Email 131802 0
marie.yap@monash.edu
Contact person for public queries
Name 131803 0
Elizabeth Nicolaou
Address 131803 0
School of Psychological Sciences Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
Country 131803 0
Australia
Phone 131803 0
+61 03 9905 9448
Fax 131803 0
Email 131803 0
liz.nicolaou@monash.edu
Contact person for scientific queries
Name 131804 0
Marie Yap
Address 131804 0
School of Psychological Sciences Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
Country 131804 0
Australia
Phone 131804 0
+61 03 9905 1250
Fax 131804 0
Email 131804 0
marie.yap@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Quantitative data
-Parenting to Reduce Depression and Anxiety-Autism (PaRCADS- Autism)
-Parenting Self Efficacy Scale-Autism (PSES-A)
-Paediatric Symptom Checklist (PSC-17)
-Emotion Dysregulation Inventory (EDI)
-Child and Adolescent Scale of Participation (CASP)
-Kessler Screening Scale for Psychological Distress (K6)
-Client Satisfaction Questionnaire (CSQ-8)
-Sleep Problem Question (LSAC- Wave 6 Parent Questionnaire)
-Interference of Sleep Problem Question (adapted from ISI)
When will data be available (start and end dates)?
Data will be available immediately following publication, no end date determined
Available to whom?
Available to anyone based on Primary Investigator discretion
Available for what types of analyses?
Any approved purpose by Primary Investigator
How or where can data be obtained?
Access subject to approval by Principal Investigator
Marie Yap - marie.yap@monash.edu


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.