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DEFINITIONS
Trial Review
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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.
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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
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Secondary ID [1]
314681
0
None
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Universal Trial Number (UTN)
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Trial acronym
PiP Kids
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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.
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Health condition
Health condition(s) or problem(s) studied:
Parenting Practices
337848
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Child Anxiety
337849
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Child Depression
337850
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Condition category
Condition code
Public Health
334178
334178
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0
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Health promotion/education
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Public Health
334179
334179
0
0
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Health service research
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Mental Health
334180
334180
0
0
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Anxiety
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Mental Health
334181
334181
0
0
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
331314
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Behaviour
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Intervention code [2]
331648
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Prevention
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
342007
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Preventive parenting practices (quantitative)
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Assessment method [1]
342007
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Change in total score on the Parenting to Reduce Child Anxiety and Depression Scale (PaRCADS)
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Timepoint [1]
342007
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1) Pre-program: baseline survey package 2) Post-program: 90 days from module selection date
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Primary outcome [2]
342008
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Parental self-efficacy (quantitative)
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Assessment method [2]
342008
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Change in total score on the Parental Self-Efficacy Scale - Child (PSES-C)
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Timepoint [2]
342008
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1) Pre-program: baseline survey package 2) Post-program: 90 days from module selection date
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Secondary outcome [1]
449288
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Child internalising symptoms (anxiety and depression) (quantitative)
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Assessment method [1]
449288
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Change in Internalising Subscale score on the Paediatric Symptom Checklist (PSC-17)
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Timepoint [1]
449288
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1) Pre-program: baseline survey package 2) Post-program: 90 days from module selection date
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Secondary outcome [2]
449289
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Program uptake - website click through rate (quantitative)
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Assessment method [2]
449289
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Total number of times the PiP Kids website link is selected via any linked Raising Children Network webpage, assessed via website analytics.
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Timepoint [2]
449289
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1) Pre-program
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Secondary outcome [3]
449290
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Program uptake - program registrations (quantitative)
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Assessment method [3]
449290
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Total number of users that register for the PiP Kids website assessed via website analytics.
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Timepoint [3]
449290
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1) Pre-program
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Secondary outcome [4]
449299
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Program uptake - profile completion (quantitative)
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Assessment method [4]
449299
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Total number of users that complete the PiP Kids profile page, assessed via website analytics.
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Timepoint [4]
449299
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1) Pre-program
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Secondary outcome [5]
449300
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Program uptake - pre-program survey completion (quantitative)
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Assessment method [5]
449300
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Total number of users that complete the module selection stage (i.e. select their modules), assessed via website analytics.
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Timepoint [5]
449300
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1) Pre Program
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Secondary outcome [6]
449301
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Program uptake evaluation (facilitators and barriers) (quantitative)
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Assessment method [6]
449301
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Program uptake evaluation (facilitators and barriers) will be assessed using two study designed self report questions: 1. Where participants found out about the program including response options such as “Raising Children Network”, “recommended by a health professional”, “online website advertisement”, and an “other, please specify” option. 2. Reasons for participation, including common reasons for interest in previous PiP programs; “to learn new parenting strategies or tips”, “I’m worried about my child's current mental health” and an “other, please specify” option.
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Timepoint [6]
449301
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1) Pre-program
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Secondary outcome [7]
449302
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Ongoing engagement - program adherence (overall sample) (quantitative)
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Assessment method [7]
449302
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Ongoing Engagement - program adherence, will be defined as the percentage of participants who complete all of their selected modules out of those who completed the module selection stage. This data will be collected via website analytics. Program adherence percentage will be defined by: 100% x [(total number of participants who complete all selected modules) / (total number of participants who completed the module selection stage of the program)]. Module completion is defined as completion of 80% or more of all required module activities within each module (e.g. viewing all pages, completing in-module interactive activities, selecting a goal, completing end-of-module quiz questions).
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Timepoint [7]
449302
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1) Post-program: 90 days from module selection date
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Secondary outcome [8]
449315
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Ongoing engagement - completion of selected modules (individual participant level) (quantitative)
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Assessment method [8]
449315
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Ongoing engagement - completion of selected modules, will be defined as the percentage of the selected modules in the program that have been completed. This data will be collected via website analytics. Completion of selected modules percentage will be defined by: 100% x [(no. of selected modules completed) / (no. of modules selected)]. Module completion is defined as completion of 80% or more of all required module activities within each module (e.g. viewing all pages, completing in-module interactive activities, selecting a goal, completing end-of-module quiz questions).
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Timepoint [8]
449315
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1) Post-program: 90 days from module selection date
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Secondary outcome [9]
449316
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Ongoing engagement - total modules completed (individual participant level) (quantitative)
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Assessment method [9]
449316
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Ongoing engagement - total modules completed, will be defined as the percentage of modules completed out of the total of 12 modules. This data will be collected via website analytics. Percentage of total modules completed will be defined by: 100% x [(no. of completed modules) / 12]. Module completion is defined as completion of 80% or more of all required module activities within each module (e.g. viewing all pages, completing in-module interactive activities, selecting a goal, completing end-of-module quiz questions).
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Timepoint [9]
449316
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1) Post-program: 90 days from module selection date
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Secondary outcome [10]
449317
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Quality of program engagement (quantitative)
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Assessment method [10]
449317
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Quality of program engagement, will be defined as the percentage of module goals that are completed. Percentage of goals completed will be defined by: 100% x [(completed goals) / (selected goals)]. This data will be collected via website analytics.
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Timepoint [10]
449317
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1) Post-program: 90 days from module selection date
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Secondary outcome [11]
449318
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Program ongoing engagement evaluation (facilitators and barriers) (quantitative)
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Assessment method [11]
449318
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Program ongoing engagement evaluation (facilitators and barriers) will be assessed using responses to the individual items of an adapted version of the headspace Family Post-Session Survey (headspace National, 2023) which will be used to explore whether identified factors are facilitators or barriers of ongoing intervention engagement. Adaptation of the Family Post-Session Survey for this purpose involves replacing the words “this session” with “the program” in the survey questions (e.g. changing original items such as “The session focused on the issues that are important to my family” to “The program focused on the issues that are important to my family”). The survey consists of 6 items, scored on a 7-point Likert-type scale (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree and not applicable).
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Timepoint [11]
449318
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1) Post-program: 90 days from module selection date
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Secondary outcome [12]
449319
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Program satisfaction (quantitative)
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Assessment method [12]
449319
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Program satisfaction will be assessed with an adapted version of the headspace Family Post-Session Survey (headspace National, 2023). Adaptation of this survey for this purpose involves replacing the words “this session” with “the program” in the survey questions (e.g. changing original item “The session focused on the issues that are important to my family” to “The program focused on the issues that are important to my family”; “The program was helpful”; “The program helped me understand my child and their situation more clearly”). The survey consists of 6 items, scored on a 7-point Likert-type scale (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree and not applicable). Item scores will be summed to form a total satisfaction score, with higher scores indicating higher satisfaction.
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Timepoint [12]
449319
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1) Post-program: 90 days from module selection date
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Secondary outcome [13]
449320
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Pre-program goal attainment (quantitative)
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Assessment method [13]
449320
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Pre-program goal attainment will be assessed using a study designed program goal question where participants will rate how much the program has helped them achieve their pre-program goals (e.g. 'No, not at all', 'Yes, a little', 'Yes, moderately' or 'Yes, mostly'). Higher scores indicate higher level of goal attainment.
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Timepoint [13]
449320
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1) Post-program: 90 days from module selection date
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Secondary outcome [14]
449321
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Pre-program goal attainment evaluation (qualitative)
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Assessment method [14]
449321
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Pre-program goal attainment evaluation will be assessed using participant responses to a study-designed question where participants will explain why the program did/ did not assist to achieve pre-program goals.
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Timepoint [14]
449321
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1) Post-program: 90 days from module selection date
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Secondary outcome [15]
449322
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Program experience (qualitative)
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Assessment method [15]
449322
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Program experience will be assessed via participant semi structured interviews. Questions will focus on (1) parents' experience of the PiP Kids program; (2) acceptability of the program; and (3) contextual factors that may have influenced their capacity to engage with the intervention or to implement intervention strategies.
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Timepoint [15]
449322
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1) Post-program: 90 days from module selection date
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Eligibility
Key inclusion criteria
Parents/caregivers who live in Australia, who self nominate via the Raising Children Network.
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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
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Single group
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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
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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/10/2025
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Actual
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Date of last participant enrolment
Anticipated
15/10/2027
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Actual
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Date of last data collection
Anticipated
15/01/2028
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Actual
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Sample size
Target
2000
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Accrual to date
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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]
319229
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University
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Name [1]
319229
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Turner Institute for Brain and Mental Health
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Address [1]
319229
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Country [1]
319229
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Australia
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Funding source category [2]
319475
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Other
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Name [2]
319475
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Raising Children Network
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Address [2]
319475
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Country [2]
319475
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
321782
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Address [1]
321782
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Country [1]
321782
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Other collaborator category [1]
283568
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Other
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Name [1]
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Raising Children Network
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Address [1]
283568
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Country [1]
283568
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317808
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
317808
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
317808
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Australia
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Date submitted for ethics approval [1]
317808
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13/06/2025
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Approval date [1]
317808
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17/07/2025
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Ethics approval number [1]
317808
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47380
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Summary
Brief summary
This study aims to evaluate the uptake, engagement and short-term effects of an online parenting program 'Partners in Parenting Kids' (PiP Kids). The online program is designed for parents/caregivers of children aged between 5-11 years and is comprised of up to 12 online self guided educational modules empowering parents/caregivers to support their child to prevent or reduce symptoms of depression and anxiety. Before commencing the program, participants will be able to select between a ‘Tailored’ pathway to their program (i.e. program content is personalised based on responses to an initial self assessment) or a ‘Non-tailored’ pathway (i.e. program content is completely self selected with no self assessment completed) . The project aims to evaluate the PiP Kids program for its: (1) uptake and engagement via the Raising Children Network (RCN) website (2) effects on preventive parenting practices, parental self-efficacy and child internalising symptoms (3) parent/caregiver program satisfaction (4) ability to meet parent/caregiver initial pre-program goals We also aim to explore parent/caregivers’ qualitative feedback about their experiences of PiP Kids through qualitative feedback interviews conducted at the post-program timepoint. No hypotheses are specified for this aim. For Aims (1) to (4), it is hypothesised that from pre to post program (90 days later) users who complete the PiP Kids program will report: (1) improved (higher) scores on the The Parenting to Reduce Child Anxiety and Depression Scale (PaRCADS), indicating improvements in preventive parenting practices; (2) improved (higher) scores on the Parental Self-Efficacy Scale-Child (PSES-C), indicating increased parental self-efficacy in parenting domains associated with child depression and anxiety; (3) reduced scores on the parent-report version of the Paediatric Symptoms Checklist (PSC-17) internalising subscale, indicating reduced internalising symptoms in their child; (4) the program to be satisfactory and meeting their initial pre-program goals
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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
142226
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Prof Marie Yap
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Address
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School of Psychological Sciences, Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
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Country
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Australia
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Phone
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+61 03 9905 1250
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Fax
142226
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Email
142226
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[email protected]
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Contact person for public queries
Name
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Elizabeth Nicolaou
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Address
142227
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School of Psychological Sciences Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
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Country
142227
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Australia
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Phone
142227
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+61 03 9905 9448
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Fax
142227
0
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Email
142227
0
[email protected]
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Contact person for scientific queries
Name
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Marie Yap
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Address
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School of Psychological Sciences Building 17, 18 Innovation Walk Monash University Clayton Victoria 3800
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Country
142228
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Australia
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Phone
142228
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+61 03 9905 1250
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Fax
142228
0
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Email
142228
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[email protected]
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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.
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