Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000854831
Ethics application status
Approved
Date submitted
11/06/2021
Date registered
2/07/2021
Date last updated
7/03/2023
Date data sharing statement initially provided
2/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effects of an online parenting program with peer support (PiP-Plus) for parents of adolescents (aged 12 to 17) on parent confidence and parent and adolescent wellbeing during the COVID-19 pandemic
Scientific title
An open-label, uncontrolled trial to examine the effects of an enhanced online parenting intervention with peer support (PiP-Plus) on parental self-efficacy, parenting and parent and adolescent wellbeing outcomes in parents of adolescents aged 12-to-17 years during the COVID-19 pandemic
Secondary ID [1] 304357 0
None
Universal Trial Number (UTN)
U1111-1269-1591
Trial acronym
PiP-Plus
Linked study record
This trial is linked to the following three previous trials which examined the Partners in Parenting (PiP) intervention, the same program being adapted for use in the current trial.

1. ACTRN12619001781134 - open access trial of PiP for parents of adolescents aged 12-to-17 years,

2. ACTRN12615000328572 - RCT evaluating PiP compared to an active control condition.

3. ACTRN12615000247572 - RCT evaluating a brief, single-session version of PiP, compared to a waitlist control.

Health condition
Health condition(s) or problem(s) studied:
COVID-19-specific parental self-efficacy 322133 0
Risk and protective factors for adolescent depression and anxiety disorders that parents can potentially modify 322134 0
Parental self-efficacy in parenting to reduce adolescent depression and anxiety (not COVID-19-specific) 322136 0
Parent psychological distress 322137 0
Adolescent depression symptoms 322140 0
Adolescent anxiety symptoms 322265 0
Condition category
Condition code
Public Health 319834 319834 0 0
Health promotion/education
Mental Health 319835 319835 0 0
Depression
Mental Health 319836 319836 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The new program, PiP-Plus, will enhance PiP by adding the following features: 1) COVID-19 specific content, including addition of one new module on parenting during COVID-19, and minor additions to existing modules to ensure relevance during the COVID-19 pandemic; 2) addition of moderated online Peer Support Groups, delivered via Facebook, available for PiP-Plus parent participants to join; and 3) use of a Rapidly Responsive Process to deploy new content to PiP-Plus, to address emergent parent needs identified in the Peer Support Groups.

Parents will receive the following as part of the PiP-Plus intervention:

1) Parents first complete an online self-assessment of their current self-efficacy in relation to parenting during the COVID-19 pandemic (COVID-19-PSES), and parenting practices associated with risk of adolescent depression and anxiety disorders (the Parenting to Reduce Adolescent Depression and Anxiety Scale [PRADAS]). The COVID-19-PSES, developed for use in this study, assesses parent confidence across the core domains of parenting during COVID-19 which have been added to the PiP-Plus program. The PRADAS assesses parenting practices in relation to the recommendations in the evidence-base parenting guidelines "How to Prevent Depression and Clinical Anxiety in your Teenager: Strategies for Parents" (Parenting Strategies Program, 2013; henceforth the Guidelines), which form the basis of the existing PiP content.

2) Based on their responses to the COVID-19-PSES and PRADAS, parents receive an individually-tailored feedback report. The feedback highlights areas of parenting strength and/or confidence, and provides practical strategies for identified areas for improvement. The feedback report is displayed to parents online (on their 'personal dashboard' as part of the PiP-Plus program). Parents are also emailed a PDF copy of their feedback, as well as a copy of the Guidelines.

3) Based on the identified areas for improvement (PRADAS) and/or low confidence levels (COVID-19-PSES), parents are recommended up to 10 interactive online modules. The modules provide practical strategies to support parents to make changes to their parenting in order to align more closely with the parenting recommendations in the Guidelines, and the new COVID-19-specific parenting recommendations. Although parents are recommended certain modules based on their initial self-assessment, they can further tailor their program by selecting additional modules or de-selecting modules recommended to them. Parents can select between 1 and 10 modules to add to their personalised program. By default, modules will ‘unlock’ (i.e. become available for parents to complete) at a rate of one module per week, until all selected modules have been unlocked. Parents are notified by email when a new module unlocks. If they prefer, parents 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 become available for parents to complete if they wish. Parents can revisit any modules they have already completed at any time.

The interactive modules can be accessed online, from any device with internet access (including smartphones). The modules include illustrations, audio clips, videos, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. The module topics include: parenting during the COVID-19 pandemic; parent-child relationship; parental involvement and autonomy granting; encouraging supportive relationships; establishing family rules; minimising conflict in the home; encouraging good health habits; problem solving; managing anxiety; and seeking professional help. Each module takes about 15-25 minutes to complete, depending on the topic and how parents engage with the module. Parents are invited to complete their first module immediately after they have completed their baseline survey and received their personalised feedback report.

4) Parents will also be invited to join an online, private and invitation-only Peer Support Group (PSG) via Facebook. This step will be optional, parents can continue to complete the rest of the PiP-Plus program without joining the PSG if they wish. Parents will initially be invited to view an information page (via an invitation-only link) on Facebook that explains what the PSGs will involve, after which parents can choose to either join or not join the PSG. If parents chose to join the PSG, they will be prompted to complete an induction process.
The induction process will include an outline of the community rules (including safety, security, code of conduct, moderation and functionalities; and brief information about potential topics offered in the large and small groups).

After going through the induction process, parents will join the large PSG Facebook group. The PSG also includes multiple small topic-based Facebook groups created according to parents' shared interests, requested topics and their discussion in the PSG Facebook groups. Parents can choose to join (or not) according to their current preferences, interests and personal goals related to the PiP-Plus program.

The key purpose of the large group is to present informational support to parents. The information will include administrator (e.g. dedicated staff from the research team) posts and comments, parent-generated posts or comments, and periodic summaries of topics and discussions created by administrators of the group. It will also include information about the small topic-based groups that parents can join on a voluntary basis. The small groups component of the PSG aims to provide social and emotional support to parents. In these groups, parents can connect with one another, share discussions related to PiP-Plus content and parenting in general. The interactions in the small groups will be facilitated to some degree to maintain the level of engagement from parents.

Parents can choose to leave the groups at any stage. When parents choose to leave, their feedback will be sought via Facebook with an option for parents to decide whether or not to respond.

New PiP-Plus content will be added throughout the duration of the trial via a Rapidly Responsive Process (RRP). The RRP includes two components: 1) identification of emergent needs from asynchronous interactions between parents in the Peer Support Groups (as outlined above, see point 4); and 2) expert-consensus-based responses via iterative cycles as required to generate actionable strategies and resources to be deployed on PiP-Plus. Two RRP cycles are anticipated to be completed during the trial, with the first commencing approximately two-to-three months after commencement of the trial. Each RRP cycle will commence with the identification of new COVID-19-relevant challenges faced by parents, based on PSG interactions. Topics that are not already addressed by PiP-Plus will be identified as potential new topics to be incorporated into PiP-Plus. A rapid Delphi expert consensus survey will be conducted for each new topic, using expert members of the research team as Delphi expert panel members. The rapid Delphi process will identify new, actionable parenting strategies which will be incorporated into PiP-Plus. New PiP-Plus content will be distributed to parents via the online Peer Support Groups, on the PiP-Plus website and by email and/or SMS to alert parents to the new content.

Adherence and completion of the PiP-Plus intervention will be calculated as follows:

Adherence = 100% x [(number of participants whose observed usage equals their intended usage) / (number of participants who received the intervention)].

Intervention completion = percentage of program completed, calculated as: 100% x [(observed usage of the program] / (intended usage of the program)].

Where intended usage = total number of modules selected by parent; observed usage = total number of modules completed by parent.

Parent engagement in PSGs will be assessed in the form of log data and text-based data. For example, frequency of logging in, frequency and number of posts, post interactions, and questions and messages sent in small group chats. The data will be analysed to provide timely feedback to parents by the facilitator in the group, to understand parents’ engagement, and also to inform the Rapidly Responsive Process (as outlined above).

In total, participation in the study will take approximately 3 months, including program completion and completion of evaluation surveys. The baseline and follow-up assessments will take parents approximately 30 to 45-minutes per assessment. Duration will be less than 3 months if parents select less than 10 modules and/or do not complete the 90-day follow-up survey. Parents will be able to participate in the PSGs for the duration of the trial recruitment period, if they wish (up to 6-months for parents who register early in the trial). Duration of participation in the PSGs will be at the discretion of individual parents, who can join and leave at any stage.

Although the Partners in Parenting program has been evaluated previously, the program is not currently available to the public. Only participants in this study can access the online program and Peer Support Groups.
Intervention code [1] 320714 0
Behaviour
Intervention code [2] 320715 0
Prevention
Intervention code [3] 320716 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327708 0
COVID-19-specific parental self-efficacy, as measured by the total score on the COVID-19 Parental Self-Efficacy Scale (COVID-19-PSES).
The COVID-19-PSES was developed specifically for use in this trial.
The scale consists of 8 items assessing parental confidence across the parenting domains covered in the new PiP-Plus COVID-19 content.
Timepoint [1] 327708 0
The COVID-19-PSES will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [1] 396281 0
Risk and protective factors for adolescent depression and anxiety disorders that parents can potentially modify, 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.
Timepoint [1] 396281 0
The PRADAS will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [2] 396347 0
Single-item COVID-19-specific parental self-efficacy.
In addition to the COVID-19-PSES (primary outcome), which assesses domain-specific parental self-efficacy, we will also ask a single-item question about overall confidence in parenting during the pandemic
Timepoint [2] 396347 0
The single-item on COVID-19-specific parental self-efficacy will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [3] 396348 0
Parental self-efficacy in parenting practices associated with adolescent depression and anxiety (not COVID-19-specific), as measured by the total score on the Parental Self-Efficacy Scale (PSES).
Timepoint [3] 396348 0
The PSES will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [4] 396360 0
Parent psychological distress, as measured by the total score on the Kessler Psychological Distress Scale - 6-item (K6).
Timepoint [4] 396360 0
The K6 will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [5] 396361 0
Perceived social support.
Parents' perceived social support will be measured by the total score of a 5-item scale developed for use in this study.
The scale assesses key elements of peer social support that are targeted in the online Peer Support Groups.
Timepoint [5] 396361 0
The perceived social support measure will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [6] 396656 0
Parent-reported adolescent depression symptoms, as measured by the 10-item depression subscale score (sum of 10 depression item scores) on the Revised Children's Anxiety and Depression Scale (parent-report; RCADS-P).
Timepoint [6] 396656 0
The RCADS-P will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [7] 396698 0
Parent-reported adolescent anxiety symptoms, as measured by the 15-item anxiety subscale score (sum of 15 anxiety item scores) on the Revised Children's Anxiety and Depression Scale (parent-report; RCADS-P).
Timepoint [7] 396698 0
The RCADS-P will be completed at baseline and at 3-months (90 days) post-baseline completion date.

Eligibility
Key inclusion criteria
Parent or guardian of at least one child aged 12 to 17 years (inclusive) at baseline, who reside in Australia, have access to an internet-enabled device, and have sufficient English proficiency (self-determined) to engage in the PiP-Plus intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria specified.

We will not exclude parents who report clinically elevated symptoms of anxiety or depression in their adolescents at baseline. However, by assessing baseline symptoms, we will be able to conduct subsidiary subgroup analyses of parents of adolescents above/below clinical cut-off scores on the symptom measures, to examine the program effects on these subgroups.
The cut-off scores used to determine symptom elevation will be based on published cut-off scores, as follows:
RCADS-P depression subscale T-score of 70 or greater.
RCADS-P anxiety subscale T-score of 70 or greater.

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)
Allocation is not concealed
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
The absence of effect size estimates on the COVID-specific outcomes precludes a precise calculation of the required sample size. 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 6 months, at least 500 parents (up to 2000) to enable moderation/subgroup analyses based on sociodemographic factors and PSG engagement.

Pre-post analyses of primary and secondary outcomes will be conducted using paired-samples t-tests for each primary and secondary outcome measure.

To examine the associations between parent engagement in PSGs, engagement in PiP-Plus modules, perceived social support, parental self-efficacy, and parent psychological distress, a series of regressions and mediation analyses using Hayes' Macros will be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/10/2021
Actual
26/10/2021
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
500
Accrual to date
1000
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308726 0
Government body
Name [1] 308726 0
National Health and Medical Research Council (NHMRC)
Country [1] 308726 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
Country
Australia
Secondary sponsor category [1] 309724 0
None
Name [1] 309724 0
Address [1] 309724 0
Country [1] 309724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308648 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 308648 0
Ethics committee country [1] 308648 0
Australia
Date submitted for ethics approval [1] 308648 0
12/07/2021
Approval date [1] 308648 0
10/08/2021
Ethics approval number [1] 308648 0

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

Contacts
Principal investigator
Name 111426 0
A/Prof Marie Yap
Address 111426 0
Turner Institute for Brain and Mental Health
Addiction and Mental Health Program
School of Psychological Sciences, Monash University
Room 616
18 Innovation Walk
Monash University
Clayton VICTORIA 3800
Country 111426 0
Australia
Phone 111426 0
+61 3 9905 0723
Fax 111426 0
Email 111426 0
marie.yap@monash.edu
Contact person for public queries
Name 111427 0
Marie Yap
Address 111427 0
Turner Institute for Brain and Mental Health
Addiction and Mental Health Program
School of Psychological Sciences, Monash University
Room 616
18 Innovation Walk
Monash University
Clayton VICTORIA 3800
Country 111427 0
Australia
Phone 111427 0
+61 3 9905 0723
Fax 111427 0
Email 111427 0
marie.yap@monash.edu
Contact person for scientific queries
Name 111428 0
Marie Yap
Address 111428 0
Turner Institute for Brain and Mental Health
Addiction and Mental Health Program
School of Psychological Sciences, Monash University
Room 616
18 Innovation Walk
Monash University
Clayton VICTORIA 3800
Country 111428 0
Australia
Phone 111428 0
+61 3 9905 0723
Fax 111428 0
Email 111428 0
marie.yap@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results (i.e. responses to the outcome measures listed).
When will data be available (start and end dates)?
Immediately following publication. No end date determined.
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
IPD meta-analyses, or any other purpose deemed appropriate by the Primary Sponsor.
How or where can data be obtained?
Approval by the Principal Investigator, Associate Professor Marie Yap, marie.yap@moansh.edu


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.