ANZCTR - Registration

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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]

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

Parental self-efficacy

Adolescent depression

Adolescent anxiety

Condition category

Condition code

Public Health

Health promotion/education

Public Health

Health service research

Mental Health

Anxiety

Mental Health

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]

Behaviour

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.

Primary outcome [2]

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]

1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.

Secondary outcome [1]

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]

1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.

Secondary outcome [2]

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]

1) Pre-intervention (baseline).
2) Post-intervention: 3-months (90 days) from date of module selection.

Secondary outcome [3]

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]

Cumulative data will be assessed at the conclusion of the enrolment period.

Secondary outcome [4]

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]

On entry to the trial.

Secondary outcome [5]

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]

Post-intervention: 3-months (90 days) from date of module selection

Secondary outcome [6]

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]