Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001781134
Ethics application status
Approved
Date submitted
6/12/2019
Date registered
17/12/2019
Date last updated
11/04/2022
Date data sharing statement initially provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Partners in Parenting: Evaluating the real-world use and impact of an online tailored parenting program for parents of adolescents.
Scientific title
An open access trial examining the effects of an individually-tailored, web-based parenting program (Partners in Parenting) for parents of 12-to-17-year-olds to reduce risk and protective factors for adolescent depression and anxiety disorders.
Secondary ID [1] 299983 0
None
Universal Trial Number (UTN)
U1111-1244-9824
Trial acronym
Linked study record
This study is linked to the following two previous trials. These trials were RCTs of the program being evaluated in the current open access trial.

ACTRN12615000328572 was an RCT evaluating the full Partners in Parenting program for parents of adolescents, compared to an active control condition (educational materials).

ACTRN12615000247572 was an RCT of a brief version of the Partners in Parenting program (single session, pesonalised feedback only), compared to a waitlist control.

Health condition
Health condition(s) or problem(s) studied:
Risk and protective factors for adolescent depression and anxiety disorders that parents can potentially modify 315453 0
Parental self-efficacy 315517 0
Parent-adolescent attachment 315518 0
Adolescent depression 315519 0
Adolescent anxiety 315520 0
Condition category
Condition code
Mental Health 313753 313753 0 0
Depression
Mental Health 313754 313754 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a web-based parenting program called Partners in Parenting (PiP). PiP consists of three components: 1) parents first complete an online self-assessment of their 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-base parenting guidelines "How to Prevent Depression and Clinical Anxiety in your Teenager: Strategies for Parents" (Parenting Strategies Program, 2013; henceforth the Guidelines); 2) based on their responses to the PRADAS, parents receive an individually-tailored feedback report. The feedback highlights areas of strength, and provides practical strategies for identified areas for improvement; 3) based on the identified areas for improvement, parents are recommended up to 9 interactive online modules to support them in making changes to their parenting. The overarching aim of the personalised feedback and online modules is to support parents to make changes to their parenting in order to align more closely with the parenting recommendations in the Guidelines. Although parents are recommended certain modules based on their responses to the PRADAS, they can further tailor their program by selecting additional modules or de-selecting modules recommended to them.

The feedback report is displayed to parents online (on their 'personal dashboard' as part of the PiP program). Parents are also emailed a PDF copy of their feedback, as well as a copy of the Guidelines.

The interactive modules can be accessed online, from any device with internet access (including smartphones). The modules include illustrations, audio clips, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. The module topics include: 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 feedback report. Thereafter they are encouraged to complete one module per week (in a set order) until they have completed their whole program. After completing all of their selected modules, parents can continue to access all nine modules as many times as they like.

The online program is self-guided, with email and SMS reminders from the research team. Parents receive email and SMS reminders if they are inactive in the online program for a specified time period. Reminders consist of a standard email followed by a short SMS alerting the parent to the email. Reminders are sent based on the following criteria:
1) After completing the baseline assessment, if a parent has not selected their modules, they are sent up to a maximum of three reminders: 7, 14 and 21 days post-baseline completion. After this, no further reminders are made.
2) After selecting their modules, parents who do not complete any modules receive up to three reminders: at 21, 28 and 35 days post-module selection. After this, no further reminders are made.
3) Parents who complete at least one module and then become inactive (i.e. do no complete any further modules) receive a maximum of one reminder every 21 days of inactivity during the intervention period (from baseline to 90 day follow-up).
All reminders cease when the parent is due for the 90 day follow-up survey.

In total, participation in the study will take approximately 3 months, including program completion and completion of evaluation surveys. Duration will be less than 3 months if parents select less than 9 modules and/or do not complete the optional evaluation survey.

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.
Intervention code [1] 316252 0
Prevention
Intervention code [2] 316253 0
Behaviour
Intervention code [3] 316254 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322164 0
Parental risk and protective factors for 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 primary outcome of interest.
Timepoint [1] 322164 0
The PRADAS will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [1] 377551 0
Parental self-efficacy, as measured by the total score on the Parental Self-Efficacy Scale (PSES).
Timepoint [1] 377551 0
The PSES will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [2] 377553 0
Parent-adolescent attachment, as measured by the total score on the Inventory of Parent and Peer Attachment, parent-report (IPPA-P).
Timepoint [2] 377553 0
.The IPPA-P will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [3] 377722 0
Parent-reported adolescent depression symptoms, as measured by the total score on the Short Mood and Feelings Questionnaire (parent-report; SMFQ-P).
Timepoint [3] 377722 0
The SMFQ-P will be completed at baseline and at 3-months (90 days) post-baseline completion date.
Secondary outcome [4] 377723 0
Parent-reported adolescent anxiety symptoms, as measured by the 15-item anxiety subscale score on the Revised Children's Anxiety and Depression Scale (parent-report; RCADS-P).
Timepoint [4] 377723 0
The RCADS-P anxiety subscale 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, consider themselves fluent in English, and have internet access and an email account.
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:
SMFQ-P total score of 8 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
Because this is an open-access effectiveness trial, no lower or upper limit on sample size has been set. However, the aim is to recruit 500 parents between 01/02/2020 and 30/06/2021.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2020
Actual
10/03/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
20/09/2021
Date of last data collection
Anticipated
31/12/2021
Actual
17/12/2021
Sample size
Target
500
Accrual to date
Final
741
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304441 0
Charities/Societies/Foundations
Name [1] 304441 0
Helen Macpherson Smith Trust
Country [1] 304441 0
Australia
Funding source category [2] 304449 0
University
Name [2] 304449 0
Monash University
Country [2] 304449 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Psychological Sciences and Turner Institute for Brain and Mental Health
Monash University,
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 304704 0
Charities/Societies/Foundations
Name [1] 304704 0
Prevention United
Address [1] 304704 0
Our Community House
552 Victoria Street
North Melbourne, Victoria 3051
Country [1] 304704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304876 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 304876 0
Ethics committee country [1] 304876 0
Australia
Date submitted for ethics approval [1] 304876 0
14/10/2019
Approval date [1] 304876 0
03/12/2019
Ethics approval number [1] 304876 0

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

Contacts
Principal investigator
Name 98498 0
A/Prof Marie Yap
Address 98498 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 98498 0
Australia
Phone 98498 0
+61 3 9905 0723
Fax 98498 0
Email 98498 0
[email protected]
Contact person for public queries
Name 98499 0
Marie Yap
Address 98499 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 98499 0
Australia
Phone 98499 0
+61 3 9905 0723
Fax 98499 0
Email 98499 0
[email protected]
Contact person for scientific queries
Name 98500 0
Marie Yap
Address 98500 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 98500 0
Australia
Phone 98500 0
+61 3 9905 0723
Fax 98500 0
Email 98500 0
[email protected]

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, [email protected]


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.