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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001117404
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
30/09/2025
Date registered
Help: Date registered
13/10/2025
Date last updated
Help: Date last updated
24/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability, feasibility, and short-term effects of a self-guided online parenting program (‘PiP Malaysia') to empower parents in supporting their adolescents' mental health.
Scientific title
An open-label, uncontrolled acceptability and feasibility trial of an online parenting program (‘PiP Malaysia') to empower parents in supporting their adolescents' mental health.
Additional trial identifiers [1] 315127 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Parental self-efficacy 338548 0
Adolescent anxiety 338549 0
Adolescent depression 338550 0
Condition category
Condition code
Public Health 334851 334851 0 0
Health promotion/education
Mental Health 334852 334852 0 0
Anxiety
Mental Health 334853 334853 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention, ‘Partners in Parenting Malaysia’ (PiP Malaysia) is a new culturally-adapted version of the Partners in Parenting (PiP) program (refer to ACTRN12615000328572 and ACTRN12619001781134). The original PiP program is an online parenting program designed to equip parents with evidence-based parenting strategies to reduce the risk of anxiety or depression in their 12-17-year-old adolescent. PiP Malaysia has been adapted to empower parents in the Malaysian cultural context to support their adolescents' mental health.

The PiP Malaysia intervention consists of a web-based program which includes two web-based modules covering topics related to 1) parent-teen relationships and 2) establishing family rules.

Parents will receive the following as part of the PiP Malaysia intervention:

1) Parents first complete a baseline survey package, which includes a measure of their parenting practices associated with risk of adolescent depression and anxiety disorders (the Parenting to Reduce Adolescent Depression and Anxiety Scale [PRADAS]). The PRADAS assesses parenting practices in relation to the recommendations in the evidence-based parenting guidelines "How to Prevent Depression and Clinical Anxiety in your Teenager: Strategies for Parents" (Parenting Strategies Program, 2013; henceforth the Guidelines), which form the basis of the original PiP program content. Parents will also report on their parental self-efficacy (the Parental Self-Efficacy Scale [PSES]), and adolescent mental health (the Parent-Reported Strengths and Difficulties Questionnaire [SDQ]). Parents will have the option to respond to the surveys in either English or Malay.

2) Parents will receive access to two interactive online modules.
The modules provide practical strategies to support parents to make changes to their parenting to align more closely with the parenting recommendations in the Guidelines and evidence-based content curated to further support parenting within a Malaysian cultural context. By default, modules will ‘unlock’ (i.e. become available for parents to complete) at a rate of one module per week, until both modules have been unlocked. Parents are notified by email and SMS/Whatsapp (if they opt in to SMS/Whatsapp 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. 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, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. Each module takes about 20-35 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.

3) 1 month (4 weeks) after the completion of the baseline survey package, parents will be prompted to complete a post-intervention survey package, which includes the same measures as in the baseline survey (PRADAS, PSES and SDQ). As in the baseline survey, parents will have the option to respond to these surveys in English or Malay.

Intervention adherence will be monitored through website analytics (module completion).

Note. The intervention period is anticipated to run for 2-4 weeks (up to 1 month), depending on the rate at which parents complete the online modules.

References:
Cardamone-Breen, M. C., Jorm, A. F., Lawrence, K. A., Mackinnon, A. J., & Yap, M. B. (2017). The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders. PeerJ, 5, e3825.

Goodman, R. (1997). Strengths and Difficulties Questionnaire (SDQ) [Database record]. APA PsycTests.

Nicolas, C. C., Jorm, A. F., Cardamone-Breen, M. C., Lawrence, K. A., & Yap, M. B. H. (2020). Parental Self-Efficacy for Reducing the Risk of Adolescent Depression and Anxiety: Scale Development and Validation. Journal of research on adolescence, 30(1), 249-265.

Parenting Strategies Program (2013). How to prevent depression and clinical anxiety in your teenager: Strategies for parents. Melbourne: beyondblue.
Intervention code [1] 331751 0
Behaviour
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342488 0
Intervention acceptability (qualitative)
Timepoint [1] 342488 0
Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [1] 450992 0
Parental self-efficacy for reducing the risk of adolescent depression and anxiety (quantitative)
Timepoint [1] 450992 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [2] 451010 0
Risk and protective factors for adolescent depression and anxiety disorders that parents can potentially modify (quantitative).
Timepoint [2] 451010 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [3] 451011 0
Program completion percentage (quantitative)
Timepoint [3] 451011 0
Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [4] 452694 0
Adolescent internalising symptoms reported by parent report (quantitative)
Timepoint [4] 452694 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [5] 452695 0
Adolescent externalising symptoms reported by parent report (quantitative)
Timepoint [5] 452695 0
1) Pre-intervention (baseline survey package) 2) Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [6] 452696 0
Validity of the intervention (qualitative)
Timepoint [6] 452696 0
Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [7] 452697 0
Intervention acceptability (quantitative)
Timepoint [7] 452697 0
Post-intervention: 1 month (4 weeks) from parent baseline completion date.
Secondary outcome [8] 462917 0
Reasons for non-engagement
Timepoint [8] 462917 0
1 month (4 weeks) post-completion of the expression of interest survey

Eligibility
Key inclusion criteria
Parents and/or caregivers:
- Of adolescents aged 12-17 years attending a secondary school in Malaysia
- Of Malaysian nationality
- Who live in Malaysia
- Who have regular contact with their adolescent (>5 days a week)
- Who can read, write, speak, and communicate in English
- Who have regular access to the Internet and an email address.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- Parents of an adolescent who is not Malaysian and currently residing in Malaysia
- Parents who do not have regular contact with their adolescent (< 6 days a week)
- Parents who cannot read and write in English
- Parents who do not have regular access to the Internet or an email address.

Study design
Purpose of the study
Prevention
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
A sample size of 25-30 parents will be recruited to receive the intervention. A sample size of 10 has been found to be appropriate for pilot studies estimating effect size (Birkett & Day, 1994) and is in alignment with guidance for evaluating interventions published by the Medical Research Council (Craig et al., 2008).

To assess short-term effects in primary and secondary outcomes, paired samples t-tests or appropriate non-parametric tests will be conducted for each measure (PRADAS, PSES, SDQ).

Analysis of quantitative program acceptability and feasibility outcomes will be largely descriptive. Program acceptability will be measured qualitatively and quantitatively. Qualitative data will be collected via semi- structured interviews for parents pertaining to program acceptability, feasibility, and efficacy. The qualitative data will be then analysed with thematic analysis, adhering to the 6 phases outlined by Braun & Clarke (2021) with themes identified deductively against Theoretical Framework of Acceptability (TFA) questionnaire (Sekhon et al. 2022) and theories which have informed the PiP Malaysia intervention design (e.g., the supportive accountability model and persuasive system design model; Mohr et al., 2011; Oinas- Kukkonen, H., & Harjumaa, M., 2009; Yap et al., 2017).

Quantitative program feasibility outcomes will be calculated as percentages (e.g., percentages of online modules completed, percentage of the sample who adhered to program requirements) 1 month post intervention commencement. Program acceptability, as measured quantitatively via the Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979), will be analysed individually for each participant. Scores of individual items in the CSQ-8 will be summed to yield a global rating of program satisfaction out of 32 for each participant.

References:
Birkett, M. A., & Day, S. J. (1994). Internal pilot studies for estimating sample size. Statistics in Medicine, 13, p2455-2463.

Braun, V., & Clarke, V. (2021). Thematic analysis: A practical guide. Sage.

Craig, P., Dieppe, P., Macintyre, S., Michie, S., Nazareth, I., & Petticrew, M. (2008). Developing and evaluating complex interventions: The new Medical Research Council guidance. BMJ, a1655. https://doi.org/10.1136/bmj.a1655


Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning, 2, 197-207.

Sekhon, M., Cartwright, M., & Francis, J. J. (2017). Acceptability of healthcare interventions: An overview of reviews and development of a theoretical framework. BMC Health Services Research, 17(1). https://doi.org/10.1186/s12913-017-2031-8

Stemler, S. E. (2001). An overview of content analysis. Practical Assessment, Research, and Evaluation, 7(17). Retrieved from http://pareonline.net/getvn.asp?v=7&n=17.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2026
Actual
27/03/2026
Date of last participant enrolment
Anticipated
31/03/2026
Actual
12/05/2026
Date of last data collection
Anticipated
30/06/2026
Actual
29/06/2026
Sample size
Target
30
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 27297 0
Malaysia
State/province [1] 27297 0

Funding & Sponsors
Funding source category [1] 319705 0
University
Name [1] 319705 0
Monash University
Country [1] 319705 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 322210 0
None
Name [1] 322210 0
Address [1] 322210 0
Country [1] 322210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318259 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 318259 0
Ethics committee country [1] 318259 0
Australia
Date submitted for ethics approval [1] 318259 0
29/08/2025
Approval date [1] 318259 0
07/10/2025
Ethics approval number [1] 318259 0
48802

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

Contacts
Principal investigator
Name 143610 0
Prof Marie Yap
Address 143610 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Building 17, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country 143610 0
Australia
Phone 143610 0
+61 399050723
Fax 143610 0
Email 143610 0
[email protected]
Contact person for public queries
Name 143611 0
Darlene Koh
Address 143611 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Building 17, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country 143611 0
Australia
Phone 143611 0
+61432207343
Fax 143611 0
Email 143611 0
[email protected]
Contact person for scientific queries
Name 143612 0
Marie Yap
Address 143612 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Building 17, 18 Innovation Walk Clayton Campus, Clayton VIC 3800 Australia
Country 143612 0
Australia
Phone 143612 0
+61 399050723
Fax 143612 0
Email 143612 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: We will make non-identifiable and password-protected data files available via Figshare, but access to full data will be granted by the trial custodian if the above-mentioned conditions are met. Figshare is a trusted, generalist repository that supports data transparency and long-term preservation, adhering to FAIR principles. Figshare issues DOIs for all published files, ensuring that research outputs are showcased and managed in a discoverable, citable, reportable and transparent way.

• Email of trial custodian, sponsor or committee: [email protected] (Chief investigator)

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Approval Letter-Early evaluation of the 'Partners in Parenting Malaysia' (PiP Malaysia) program.pdf


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.