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Trial registered on ANZCTR


Registration number
ACTRN12625000830493
Ethics application status
Approved
Date submitted
15/07/2025
Date registered
1/08/2025
Date last updated
1/08/2025
Date data sharing statement initially provided
1/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of the Partners in Parenting Kids (PiP Kids) online program on parental self efficacy and child anxiety and depression, delivered in partnership with the Raising Children Network.
Scientific title
An open-label, uncontrolled trial to evaluate the real-world uptake, engagement and effects of the Partners in Parenting Kids (PiP Kids) online program, targeting anxiety and depression in children, in partnership with the Raising Children Network
Secondary ID [1] 314681 0
None
Universal Trial Number (UTN)
Trial acronym
PiP Kids
Linked study record
PaRK Trial; ACTRN12616000621415
This current study is linked to the PaRK trial as it is a real-world implementation trial of an updated version of the PaRK program, now called the PiP Kids program.

Health condition
Health condition(s) or problem(s) studied:
Parenting Practices 337848 0
Child Anxiety 337849 0
Child Depression 337850 0
Condition category
Condition code
Public Health 334178 334178 0 0
Health promotion/education
Public Health 334179 334179 0 0
Health service research
Mental Health 334180 334180 0 0
Anxiety
Mental Health 334181 334181 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, ‘Partners in Parenting Kids’ (PiP Kids), is an updated 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/caregivers (henceforth 'parents') with evidence-based parenting strategies to prevent or reduce depression and anxiety in their child aged 5-11 years.

The PiP Kids intervention includes a web-based program drawn from the PaRK intervention and is fully self-directed online with modules covering topics related to parenting in the context of preventing or reducing a child's anxiety and/or depression (i.e. connection, managing emotions and internalising behaviours, managing conflict, establishing family rules, setting goals, when to seek help). The modules provide practical strategies to support participants to make changes to their parenting, to align more closely with the parenting recommendations in the evidence-based and expert-consensus-based Parenting Guidelines, in addition to evidence-based content curated to support participants in reducing depression and anxiety in their child. The interactive modules can be accessed online from any device with internet access (including smartphones). The modules include educational materials, illustrations, podcasts, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. Each module takes approximately 20-30 minutes to complete, depending on the topic and how participants engage with the module.

Before commencing the program, participants will be able to select between a ‘Tailored’ pathway (i.e. program content is personalised based on responses to an initial self assessment; this is the original design of the program) or a ‘Non-tailored’ pathway (i.e. program content is completely self selected with no self assessment completed; this new pathway has been created to suit the real-world implementation context).

Participants will receive the following as part of the PiP Kids program;

Tailored pathway:
1) This pathway will allow participants to first complete a self-assessment of their parenting practices as part of the pre-program surveys, which will take approximately 25-30 minutes. The self assessment will include the Parenting to Reduce Child Anxiety and Depression Scale (PaRCADS) which 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). Participants 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'. In addition, as part of the pre-program surveys, participants will also be offered the option of completing the Parental Self Efficacy Scale - Child (PSES-C) and the Paediatric Symptoms Checklist (PSC-17). The original PSES assesses parental self-efficacy in parenting to reduce the risk of adolescent depression and anxiety (see Nicolas et al, 2020). The PSES-C has been adapted specifically for use with parents of children aged 5-11 years. Responses will be rated on a 4-point Likert scale ranging from 'not at all confident' to 'very confident'. The Paediatric Symptoms Checklist (PSC-17) assesses emotional and behavioral problems in children on a 3-point Likert scale from ‘never’ to ‘often’.
2) A tailored feedback report which is based on participants' responses to the PaRCADS, which is viewable on participants’ personal dashboard. The report includes information about the parent's current parenting strengths and suggestions of practical strategies for identified areas for development.
3) Specific module recommendations based on responses to the PaRCADS. Participants can however further tailor their module selection based on their own preferences/interests by selecting additional non recommended modules, or de-selecting recommended modules if they choose.
4) Optional post-program surveys will be offered at the completion of the program including the PaRCADS, PSES-C, PSC-17 and a program evaluation survey.

The Non-tailored pathway:
1) Participants will not be required to complete the self-assessment in this pathway and will not be provided with any tailored feedback report or the module recommendations. Participants will instead be able to self-select their preferred modules right away.
2) All three surveys (PaRCADS, PSES-C, PSC-17) will be offered as optional pre-program surveys but may be skipped if participants choose not to complete them.
3) Optional post-program surveys will be offered at the completion of the program including the PaRCADS, PSES-C, PSC-17 and a program evaluation survey.

The program is designed to be completed over a period of up to 90 days. However, the duration of the intervention will differ for each participant, based on the number of modules selected and pace of module completion. A maximum of 12 modules will be available for participants to add to their personalised program. By default, modules will ‘unlock’ (i.e. become available for participants to complete) at a rate of one module per week, until all selected modules have been unlocked. Participants are notified by email when a new module unlocks. If they prefer, participants can choose to override the default unlock date, and unlock modules at an earlier date. After all initial chosen modules have been unlocked, any remaining modules, including any not initially chosen, will become available for participants to complete if they wish. Participants can revisit any modules they have already completed at any time.

Program adherence will be monitored through website analytics.

Note. Children will not be directly involved in the program.

Intervention code [1] 331314 0
Behaviour
Intervention code [2] 331648 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342007 0
Preventive parenting practices (quantitative)
Timepoint [1] 342007 0
1) Pre-program: baseline survey package 2) Post-program: 90 days from module selection date
Primary outcome [2] 342008 0
Parental self-efficacy (quantitative)
Timepoint [2] 342008 0
1) Pre-program: baseline survey package 2) Post-program: 90 days from module selection date
Secondary outcome [1] 449288 0
Child internalising symptoms (anxiety and depression) (quantitative)
Timepoint [1] 449288 0
1) Pre-program: baseline survey package 2) Post-program: 90 days from module selection date
Secondary outcome [2] 449289 0
Program uptake - website click through rate (quantitative)
Timepoint [2] 449289 0
1) Pre-program
Secondary outcome [3] 449290 0
Program uptake - program registrations (quantitative)
Timepoint [3] 449290 0
1) Pre-program
Secondary outcome [4] 449299 0
Program uptake - profile completion (quantitative)
Timepoint [4] 449299 0
1) Pre-program
Secondary outcome [5] 449300 0
Program uptake - pre-program survey completion (quantitative)
Timepoint [5] 449300 0
1) Pre Program
Secondary outcome [6] 449301 0
Program uptake evaluation (facilitators and barriers) (quantitative)
Timepoint [6] 449301 0
1) Pre-program
Secondary outcome [7] 449302 0
Ongoing engagement - program adherence (overall sample) (quantitative)
Timepoint [7] 449302 0
1) Post-program: 90 days from module selection date
Secondary outcome [8] 449315 0
Ongoing engagement - completion of selected modules (individual participant level) (quantitative)
Timepoint [8] 449315 0
1) Post-program: 90 days from module selection date
Secondary outcome [9] 449316 0
Ongoing engagement - total modules completed (individual participant level) (quantitative)
Timepoint [9] 449316 0
1) Post-program: 90 days from module selection date
Secondary outcome [10] 449317 0
Quality of program engagement (quantitative)
Timepoint [10] 449317 0
1) Post-program: 90 days from module selection date
Secondary outcome [11] 449318 0
Program ongoing engagement evaluation (facilitators and barriers) (quantitative)
Timepoint [11] 449318 0
1) Post-program: 90 days from module selection date
Secondary outcome [12] 449319 0
Program satisfaction (quantitative)
Timepoint [12] 449319 0
1) Post-program: 90 days from module selection date
Secondary outcome [13] 449320 0
Pre-program goal attainment (quantitative)
Timepoint [13] 449320 0
1) Post-program: 90 days from module selection date
Secondary outcome [14] 449321 0
Pre-program goal attainment evaluation (qualitative)
Timepoint [14] 449321 0
1) Post-program: 90 days from module selection date
Secondary outcome [15] 449322 0
Program experience (qualitative)
Timepoint [15] 449322 0
1) Post-program: 90 days from module selection date

Eligibility
Key inclusion criteria
Parents/caregivers who live in Australia, who self nominate via the Raising Children Network.
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
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
Power analysis and sample size calculations:
For a small effect size Cohen’s d=0.2, 80% power, a=.05, and pre-post correlations=.5, N=199 is required. We aim to recruit, over at least 24 months, at least 2000 parents (no upper limit on sample size has been specified as this is an open-access implementation trial). This will allow for attrition and enable moderation/subgroup analyses based on key demographic variables (e.g. socioeconomic position [indicated by Socio-Economic Indexes for Areas rating based on postcode], living arrangement, child age and gender, parent gender, parent Language Other Than English (LOTE) status, child symptom elevation status on baseline PSC-17 internalising subscale).

Statistical Analysis Plan:
Pre-post analysis of continuous co-primary outcomes 1 and 2 (preventive parenting practices, parental self-efficacy) and secondary outcome 1 (child internalising symptoms) will be conducted using paired-samples t-tests for each outcome measure.

Analysis of program uptake outcomes (secondary outcome 2, 3, 4, 5), ongoing engagement (secondary outcomes 7, 8, 9), quality of program engagement (secondary outcome 10), program satisfaction (secondary outcome 12) will be via descriptive statistics.

Analysis of program uptake evaluation (secondary outcome 6) will be via descriptive statistics and also content analysis (for the “Other, please specify” open text field responses).

Analysis of program ongoing engagement evaluation (secondary outcome 11) will be via correlational descriptive statistics where responses to the 6 individual items to the adapted Family Post-Session Survey will be correlated with each of the engagement indicators (see secondary outcomes 7, 8, 9, 10) to examine these factors as facilitators or barriers to engagement. Significant positive correlations will suggest that higher levels of satisfaction on each of the 6 factors are significant facilitators of engagement as indicated by the corresponding engagement variable (or that alternatively, lower levels of satisfaction along each of these dimensions are barriers to engagement).

Analysis of pre-program goal attainment will be completed via both descriptive statistics (secondary outcome 13) in addition to content analysis (secondary outcome 14).

Analysis of program experience (secondary outcome 15) will be conducted via thematic analysis of qualitative feedback interview data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319229 0
University
Name [1] 319229 0
Turner Institute for Brain and Mental Health
Country [1] 319229 0
Australia
Funding source category [2] 319475 0
Other
Name [2] 319475 0
Raising Children Network
Country [2] 319475 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321782 0
None
Name [1] 321782 0
Address [1] 321782 0
Country [1] 321782 0
Other collaborator category [1] 283568 0
Other
Name [1] 283568 0
Raising Children Network
Address [1] 283568 0
Country [1] 283568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317808 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317808 0
Ethics committee country [1] 317808 0
Australia
Date submitted for ethics approval [1] 317808 0
13/06/2025
Approval date [1] 317808 0
17/07/2025
Ethics approval number [1] 317808 0
47380

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

Contacts
Principal investigator
Name 142226 0
Prof Marie Yap
Address 142226 0
School of Psychological Sciences, Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
Country 142226 0
Australia
Phone 142226 0
+61 03 9905 1250
Fax 142226 0
Email 142226 0
Contact person for public queries
Name 142227 0
Elizabeth Nicolaou
Address 142227 0
School of Psychological Sciences Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
Country 142227 0
Australia
Phone 142227 0
+61 03 9905 9448
Fax 142227 0
Email 142227 0
Contact person for scientific queries
Name 142228 0
Marie Yap
Address 142228 0
School of Psychological Sciences Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
Country 142228 0
Australia
Phone 142228 0
+61 03 9905 1250
Fax 142228 0
Email 142228 0

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 a scientifically sound proposal or protocol
Requires approval by an ethics committee
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
De-identified individual participant data:
All outcomes data
What types of analyses could be done with individual participant data?
Any type of analysis (i.e. no restrictions on data re-use)
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?
Access subject to approval by Principal Investigator Marie Yap - [email protected]

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


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.