Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000642684
Ethics application status
Approved
Date submitted
19/05/2023
Date registered
14/06/2023
Date last updated
28/10/2024
Date data sharing statement initially provided
14/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating uptake, engagement and effects of the Partners in Parenting (PiP) online parenting program, for adult carers of adolescents (12-18), delivered via headspace National Youth Mental Health Foundation.
Scientific title
An open-label, uncontrolled implementation trial to examine uptake, engagement, and short-term effects of a self-guided, online parenting program (Partners in Parenting; PiP) on parenting, parent self-efficacy, and adolescent depression and anxiety symptoms, in adult caregivers of adolescents (aged 12 to 18), via headspace National Youth Mental Health Foundation.
Secondary ID [1] 309685 0
None
Universal Trial Number (UTN)
U1111-1291-6552
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting risk and protective factors for adolescent depression and anxiety disorders 330062 0
Parental self-efficacy 330063 0
Adolescent depression 330064 0
Adolescent anxiety 330190 0
Condition category
Condition code
Public Health 326962 326962 0 0
Health promotion/education
Public Health 326963 326963 0 0
Health service research
Mental Health 326964 326964 0 0
Anxiety
Mental Health 326965 326965 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an adapted version of the web-based parenting program Partners in Parenting (PiP). PiP consists of three components: 1) an online parenting self-assessment of current parenting practices (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); 2) an individually-tailored feedback report, based on responses to the PRADAS. The feedback highlights areas of strength, and provides practical strategies for identified areas for improvement; 3) up to 10 interactive online modules to support parents in making changes to their parenting based on the identified areas for improvement. Modules are recommended based on responses to the PRADAS. The overarching aim of the program is to support parents to make changes to their parenting in order to align more closely with the parenting recommendations in the Guidelines, and hence support their adolescent’s mental health.

The original version of PiP was developed for an intended prevention population, and included 9 modules. The version used in the current trial has been adapted for a clinical population in the following ways: 1) language and content changed from prevention-focussed to encompass prevention, early intervention, and clinical-level disorders (e.g., from “things you can do to reduce risk of depression or anxiety in your teenager” to “things you can do support your teenager’s mental health”); 2) some module content is expanded to be more appropriate for parents of adolescents with established mental health problems; 3) changing the previous final module “When things aren’t okay: Getting professional help” to be the first module “Understanding anxiety and depression”, with extended content on depression and anxiety disorders; and 4) the addition of a new module “Maintaining the gains” (content on relapse prevention) as the final module of the program.

In addition to these changes, participants in this trial will have the choice of two program pathways: 1) the fully-tailored program as described above (henceforth referred to as “Tailored program pathway”); and 2) a brief, non-tailored program (henceforth referred to as “Non-tailored program pathway”) that skips the initial assessment, feedback, and module recommendation and instead allows the participant to proceed straight to the module stage, with user-choice of modules (i.e. no tailored recommendations).

The 10 online modules included in the intervention are: 1) Understanding anxiety and depression; 2) Connect; 3) Raising good kids into great adults: Establishing family rules; 4) Breaking the anxiety cycle; 5) Calm versus conflict; 6) Partners in problem solving; 7) Good health habits for good mental health; 8) Nurture roots and inspire wings; 9) Good friends = supportive relationships; and 10) Maintaining the gains.

The intervention will comprise the following steps:
1) Choice of program pathway (tailored or brief pathway, as outlined above).
After registering for the program, participants will be informed about the two program pathways and select their preferred pathways.

2) Completion of baseline surveys & feedback.
Tailored program pathway:
Participants who choose the tailored program pathway will be offered the following surveys (see outcome measures for details): 1) PRADAS; 2) PSES; 3) RCADS-P-25.
On submission of the surveys, participants will receive their tailored parenting feedback as outlined above. Feedback about symptom elevation status on the RCADS-P-25 (i.e. informing parents whether their scores suggest that their adolescent’s symptoms are in the clinically-elevated range or not) will also be provided if the RCADS survey is completed.
All surveys will be optional, and as such, if participants choose to skip the surveys and proceed to module selection, they will not receive tailored recommendations and will continue as per the non-tailored pathway.

Non-tailored program pathway:
Participants who choose the non-tailored pathway will skip the baseline assessment and proceed straight to step 3) selection of modules. These participants will, however, be invited to complete the PSES questions to help guide their own module selection.

3) Selection of modules.
Tailored program pathway:
Participants can select between 1 and 10 of the available 10 modules for their program. Modules will be recommended based on PRADAS score. In addition, all participants will be recommended the following modules: Understanding anxiety and depression (as the first module); Maintaining the gains (as the last module). Recommended modules will be automatically selected, however parents can choose to select or deselect any modules, regardless of program recommendation.

Non-tailored program pathway:
Participants can select between 1 and 10 of the available 10 modules for their program. No modules will be recommended by the program. Modules will appear in the default order, as numbered above.

4) Module completion stage (both program pathways).
For participants in both pathways, modules will ‘unlock’ (i.e. become available) weekly, until all selected modules are unlocked, with the first module unlocked immediately following module selection. Participants will be notified via email when a new module becomes available. If they prefer, they can choose to override the default unlock date, and unlock modules at an earlier date. After all initially-selected modules have been unlocked, all remaining modules, including those not initially selected, will unlock. Modules can be revisited at any time, and completed over multiple sittings.

The interactive modules can be accessed online, from any device with internet access (including smartphones). The modules provide practical strategies to support parents to make changes to their parenting in order to align more closely with the recommendations in the Guidelines. 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 15-25 minutes to complete, depending on the topic and how parents engage with the module.

The intervention 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 (e.g. duration will be less than 90 days if participants select fewer than 10 modules and/or do not complete the optional 90-day follow-up survey).

Intervention adherence will be monitored through website analytics.
Intervention code [1] 326130 0
Behaviour
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334798 0
Parenting practices: parental risk and protective factors associated with adolescent depression and anxiety disorders, as measured by the total score on the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS). The PRADAS is a composite measure of several risk and protective factors, hence the total score is the outcome of interest.

Reference:
Cardamone-Breen, M. C., Jorm, A. F., Lawrence, K. A., Mackinnon, A. J. & Yap, M. B. H. (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.
Timepoint [1] 334798 0
1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.
Primary outcome [2] 334799 0
Correction to scoring of the Parental Self-Efficacy Scale (PSES). The scoring noted in the original registration is incorrect and should instead read as follows, to align with the scoring instructions provided by the authors of the scale:
The PSES consists of 8 items which assess a parent's current level of confidence in reducing their adolescent’s risk of depression and anxiety, measured on a four-point Likert scale (1 = 'not at all confident', 2 = 'a little confident', 3 = 'somewhat confident', 4 = 'very confident').
Timepoint [2] 334799 0
1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [1] 422120 0
Adolescent depression symptoms.
Changes to parent-reported adolescent depression symptoms, as measured by the depression subscale score of the 25-item Revised Child Anxiety and Depression Scale (RCADS-25, Parent-report; Ebesitani et al., 2017).

Reference:
Ebesitani, C., Korathu-Larson, P., Nakamura, B., Higa-McMillan, C., & Chorpita, B. (2017). The Revised Child Anxiety and Depression Scale 25-Parent Version: Scale Development and Validation in a School-Based and Clinical Sample. Assessment, 24(6), 712-728.
Timepoint [1] 422120 0
1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [2] 422121 0
Adolescent anxiety symptoms.
Changes to parent-reported adolescent anxiety symptoms, as measured by the anxiety subscale score of the 25-item Revised Child Anxiety and Depression Scale (RCADS-25, Parent-report; Ebesitani et al., 2017).
Timepoint [2] 422121 0
1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [3] 422122 0
Intervention uptake (initial engagement).
Intervention uptake will be assessed as the proportion of eligible users (defined as headspace website account holders who self-nominate as a carer of a young person) who register for the PiP program.
That is: (no. of PiP registrations) / (no. of eligible users).
This data will be collected via website analytics.
Timepoint [3] 422122 0
Cumulative data will be assessed at the conclusion of the enrolment period.
Secondary outcome [4] 422123 0
Facilitators and barriers of intervention uptake.
Facilitators and barriers of intervention uptake will be assessed via self-report in the following ways:

1. (Facilitators) Where participants found out about the program, asked as a self-report question on registration (“How did you find out about the PiP program?”. Response options will include all avenues of recruitment/communications about the program used during the trial (e.g. “my headspace account”, “recommended by an eheadspace clinician/staff”, “online advertisement”), and an “other, specify” option. Response options will be updated during the trial as new avenues of recruitment are used.

2. (Facilitators) Reasons for participation, asked as a self-report question on registration (“We are interested in your reasons for signing up for the PiP program and what you’re hoping to get from it. Please select from the list below (tick as many as apply) or add your own response by selecting “Other”.) Response options include common reasons for interest in PiP based on previous trials (e.g. “to learn new parenting strategies or tips”, “I’m worried about my young person’s current mental health”) and an “other, specify” option.
Timepoint [4] 422123 0
On entry to the trial.
Secondary outcome [5] 422124 0
Intervention satisfaction (quantitative).
Intervention satisfaction will be assessed with an adapted version of the headspace Family Post-Session Survey (headspace National, 2023). Adaptation 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 young person and their situation more clearly”). The survey consists of 6 items, scored on a 5-point likert-type scale (strongly agree, agree, somewhat agree, disagree, strongly disagree, and not applicable). Items scores will be summed to form a total satisfaction score, with higher scores indicating higher satisfaction.
Timepoint [5] 422124 0
Post-intervention: 3-months (90 days) from date of module selection
Secondary outcome [6] 422127 0
Intervention acceptability (qualitative)
Acceptability of the intervention will be assessed qualitatively via semi-structured, one-on-one, qualitative interviews, via video-conference, with a subset of participants (10-15 parents).
Timepoint [6] 422127 0
Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [7] 422536 0
Ongoing intervention engagement: Intervention adherence.
Intervention adherence (overall sample), defined as: 100% x [(number of participants who complete all of their selected modules] / (number of participants who received the intervention)].

Module completion is defined as completion of 80% or more of a-priori defined core module activities for each module (e.g. viewing all pages, completing in-module interactive activities, selecting a goal, completing end-of-module quiz questions). This data will be collected via website analytics.
Timepoint [7] 422536 0
Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [8] 422537 0
Ongoing intervention engagement: Intervention completion.
Intervention completion (individual participant level) defined as: percentage of selected program completed, calculated as: 100% x [(no. of modules completed] / (no. of modules selected)].

Module completion is defined as completion of 80% or more of a-priori defined core module activities for each module (e.g. viewing all pages, completing in-module interactive activities, selecting a goal, completing end-of-module quiz questions). This data will be collected via website analytics.
Timepoint [8] 422537 0
Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [9] 422538 0
Ongoing intervention engagement: Completion of commenced modules.
Completion of commenced modules (individual participant and module level), defined as: the percentage completion of each module a user commences (where commencing = viewing at least one module page).

Module completion is defined as completion of 80% or more of a-priori defined core module activities for each module (e.g. viewing all pages, completing in-module interactive activities, selecting a goal, completing end-of-module quiz questions). This data will be collected via website analytics.
Timepoint [9] 422538 0
Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [10] 422539 0
Quality of intervention engagement (individual participant level), defined as the percentage of selected module goals that are completed (i.e. completed goals / selected goals). This data will be collected via website analytics.
Timepoint [10] 422539 0
Post-intervention: 3-months (90 days) from date of module selection.
Secondary outcome [11] 422540 0
Facilitators and barriers of ongoing intervention engagement.
Responses to the individual items of an adapted version of the headspace Family Post-Session Survey (headspace National, 2023) will be used to explore whether any of these factors are facilitators or barriers of ongoing intervention engagement.

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 young person and their situation more clearly”). The survey consists of 6 items, scored on a 5-point likert-type scale (strongly agree, agree, somewhat agree, disagree, strongly disagree, and not applicable).
Timepoint [11] 422540 0
Post-intervention: 3-months (90 days) from date of module selection.

Eligibility
Key inclusion criteria
Adult carers with a headspace website account who self-nominate as a carer of a young person aged 12-18. Participants must reside in Australia.
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
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
Safety/efficacy
Statistical methods / analysis
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, to account 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], family composition, adolescent age and gender, parent gender, parent LOTE status, adolescent symptom elevation status on baseline RCADS-P-25).

Because this is an open-access implementation trial, no upper limit on sample size has been specified.

Pre-post analysis of continuous primary and secondary outcome measures (i.e. PRADAS, PSES, RCADS-25 depression and anxiety subscales) will be conducted using paired-samples t-tests for each outcome measure.

Analysis of intervention uptake (secondary outcome 3), facilitators and barriers to intervention uptake (secondary outcome 4), intervention satisfaction (secondary outcome 5), ongoing and engagement (secondary outcomes 7, 8, 9), and quality of engagement (secondary outcome 10), will be via descriptive statistics. “Other, specify” open text field responses will be analysed with qualitative content analysis.

Analysis of facilitators and barriers of ongoing intervention engagement (secondary outcome 11) will be as follows:
Responses to the 6 individual items of an adapted version of the headspace Family Post-Session Survey (e.g. “The program focussed on issues that are important to my family”) 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).

Qualitative interview data (program acceptability) will be analysed using thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2023
Actual
31/08/2023
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
2000
Accrual to date
887
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313879 0
Charities/Societies/Foundations
Name [1] 313879 0
headspace National Youth Mental Health Foundation
Country [1] 313879 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] 315734 0
None
Name [1] 315734 0
Address [1] 315734 0
Country [1] 315734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313027 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 313027 0
Ethics committee country [1] 313027 0
Australia
Date submitted for ethics approval [1] 313027 0
21/03/2023
Approval date [1] 313027 0
01/05/2023
Ethics approval number [1] 313027 0
37236

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

Contacts
Principal investigator
Name 126730 0
A/Prof Marie Yap
Address 126730 0
Turner Institute for Brain and Mental Health,
School of Psychological Sciences,
Monash University,
Building 17, 18 Innovation Walk
Clayton Campus,
Clayton Victoria 3800
Country 126730 0
Australia
Phone 126730 0
+61 3 9905 0723
Fax 126730 0
Email 126730 0
marie.yap@monash.edu
Contact person for public queries
Name 126731 0
Mairead Cardamone-Breen
Address 126731 0
Turner Institute for Brain and Mental Health,
School of Psychological Sciences,
Monash University,
Building 17, 18 Innovation Walk
Clayton Campus,
Clayton Victoria 3800
Country 126731 0
Australia
Phone 126731 0
+61 3 9905 1250
Fax 126731 0
Email 126731 0
mairead.cardamone-breen@monash.edu
Contact person for scientific queries
Name 126732 0
Marie Yap
Address 126732 0
Turner Institute for Brain and Mental Health,
School of Psychological Sciences,
Monash University,
Building 17, 18 Innovation Walk
Clayton Campus,
Clayton Victoria 3800
Country 126732 0
Australia
Phone 126732 0
+61 3 9905 0723
Fax 126732 0
Email 126732 0
marie.yap@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unable to share individual participant data due to privacy and confidentiality reasons as per ethics application. Participants have only provided their consent for de-identified and aggregated data disseminated to the public. Individual data will only be available to personnel who have been approved in the trial ethics application.


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.