Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000328572
Ethics application status
Approved
Date submitted
1/04/2015
Date registered
9/04/2015
Date last updated
19/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Partners in Parenting: Evaluating an online personalised parenting program
Scientific title
Examining the effects of an individually-tailored web-based parenting program (Parenting Strategies) for parents of 12- to 15-year-olds, compared to a control group that receives standard educational materials about adolescent development and mental health, on parental risk and protective factors associated with adolescent depression and anxiety, as well as on adolescent depressive and anxiety symptoms.
Secondary ID [1] 286446 0
None
Universal Trial Number (UTN)
U1111-1168-8495
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental risk and protective factors for development of adolescent depression and anxiety disorders 294614 0
Adolescent depression 294615 0
Adolescent anxiety 294616 0
Condition category
Condition code
Mental Health 294917 294917 0 0
Depression
Mental Health 294918 294918 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a web-based parenting program ('Parenting Strategies: preventing depression and anxiety') which is part of a larger research translation program (Parenting Strategies; www.parentingstrategies.net).
Parents will first complete an online Parent Survey (developed specifically for use in this study) that assesses their current parenting practices against the recommendations in the Guidelines 'How to Prevent Depression and Clinical Anxiety in Your Teenager: Strategies for Parents' (Parenting Strategies Program, 2013; henceforth the Guidelines). Based on their responses to this survey, parents in the intervention group will then (1) receive an individually-tailored feedback report that highlights areas where they are doing well (i.e., concordant with the Guidelines) and areas where they can improve (i.e., not concordant with the Guidelines), and (2) be given access to the web-based parenting intervention (up to 9 modules) to support them in making changes to identified areas of weakness in their parenting. Specific modules are recommended to parents based on their responses to the baseline Parent Survey.

Feedback messages are brief, with practical strategies provided in dot point form, and are designed to motivate behaviour change. Parents in the intervention group will view their feedback report online immediately after submitting their online baseline assessment and being randomly allocated to the intervention group. They will also be emailed a copy of their feedback report, the Parenting Guidelines, and instructions on accessing the interactive web-based parenting program with their recommended modules. Upon logging in to their parenting program, parents will see their recommended modules as well as other available modules. They can further tailor their parenting program at this stage by deselecting recommended modules and/or selecting additional modules. They then confirm their selection and can commence their personalised program. The 9 modules comprising the intervention are derived from topics covered in the Parenting Guidelines. 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 help seeking. Each module is designed to help parents make changes to their parenting so as to be more in concordance with the Guidelines. Each module takes about 15-25 minutes to complete. 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 a week (in a set order) until they have completed their whole program. Their access to their parenting program will remain open indefinitely.
All parent participants, regardless of group, will receive a weekly phone call from a researcher, starting 7 days after completing their baseline survey, and every week thereafter for at least 5 weeks The total number of weekly calls will match the number of modules in each parent's tailored parenting program; but if they have less than 5 modules, they will still receive 5 calls. Research staff will be trained to make these calls following a standard script (i.e. a standard list of questions and prompts), and will not provide individual advice or therapy. The aims of these calls are to address any study-related questions that arise, ascertain that parents progress through their allocated intervention each week till completion, and enhance retention.
Intervention code [1] 291519 0
Behaviour
Intervention code [2] 291520 0
Lifestyle
Intervention code [3] 291521 0
Prevention
Comparator / control treatment
Parents in the control group are provided with a standardized package of educational materials about adolescent development and mental health via the trial website. Parent participants receive an email a week which provides a link to the corresponding webpage with their information factsheet for that week, for 5 weeks (to match the expected mean number of modules received by the intervention group). This package provides general information to parents as opposed to tailored, actionable strategies, and is designed to represent a selection of resources that are available to parents as part of the current health promotion approach for adolescent wellbeing. The materials will be adapted from credible existing resources provided on the Raising Children Network website http://raisingchildren.net.au.
All parent participants, regardless of group, will receive a weekly phone call from a researcher, starting 7 days after completing their baseline survey, and every week thereafter for 5 weeks. Research staff will be trained to make these calls following a standard script (i.e. a standard list of questions and prompts), and will not provide individual advice or therapy. The aims of these calls are to address any study-related questions that arise, ascertain that parents progress through their allocated intervention each week till completion, and enhance retention.
Control group
Active

Outcomes
Primary outcome [1] 294670 0
Parental concordance with the Guidelines 'How to Prevent Depression and Clinical Anxiety in Your Teenager: Strategies for Parents'. This will be assessed by a parenting survey, newly developed for use in this study. The survey consists of 79 questions, and is a criterion-referenced measure assessing parents' current parenting knowledge and behaviours against specific recommendations in the Guidelines.
Timepoint [1] 294670 0
The parenting survey will be completed by both the intervention and control group parents at the following timepoints:
Baseline (pre-intervention)
3 month follow-up (post intervention)
12 month follow-up.
Primary outcome [2] 294702 0
Adolescent anxiety symptoms, as measured by the total score on the Spence Children's Anxiety Scale (SCAS). The SCAS will be administered to both parents (parent-report form) and adolescents (child-report form).
Timepoint [2] 294702 0
The parent- and child-report SCAS will be completed by both the intervention and control group (parent and child participants) at the following timepoints:
Baseline (pre-intervention).
3 month follow-up (post-intervention)
12 month follow-up.
Primary outcome [3] 294703 0
Adolescent depressive symptoms, as measured by the total score on the Short Mood and Feelings Questionnaire (SMFQ). The SMFQ will be administered to both parents (parent-report form) and adolescents (child-report form).
Timepoint [3] 294703 0
The parent- and child-report SMFQ will be completed by both the intervention and control group (parent and child participants) at the following timepoints:
Baseline (pre-intervention)
3 month follow-up (post-intervention)
12 month follow-up.
Secondary outcome [1] 313844 0
Child-reported parental concordance with the Guidelines 'How to Prevent Depression and Clinical Anxiety in Your Teenager: Strategies for Parents'. This will be assessed by a child-report version of the parenting survey developed for use in this study. The survey consists of 47 items, assessing a subset of the parenting recommendations in the Guidelines, as perceived by the child.
Timepoint [1] 313844 0
Child participants (in the intervention and control group) will complete the child-report parenting survey at the following timepoints:
Baseline
3 month follow-up (post-intervention)
12 month follow-up.

Eligibility
Key inclusion criteria
Parent Participants:
Parents or guardians of at least one child aged 12 to 15 years (inclusive), who reside in Australia, are fluent in English, have regular access to the internet and an email account.

Adolescent Participants:
Adolescent children of participating parents/guardians, aged 12 to 15 years (inclusive) on entry to the trial, who reside in Australia, are fluent in English, and have regular access to the internet.

Only one parent and one adolescent per family can participate in the trial.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents:
1. Parents who reside outside of Australia.
2. Parents who are not proficient in English.

Adolescents:
1. Adolescents who reside outside of Australia.
2. Adolescents who are not proficient in English.
3. Adolescents who do not have parental consent to participate in the study; or who do not provide verbal assent to participate. Note: parents can still participate if their child does not participate.

Parents and adolescents will not be excluded if the adolescent scores in the clinically elevated range (as determined by published clinical cut-off scores) on either the SMFQ or SCAS (either parent- or child-report form) at baseline. However, by assessing baseline symptoms, we will be able to conduct post-hoc analyses in which we exclude adolescents who scored above the clinical cut-off scores at baseline.
The cut-off scores used are as follows:
SMFQ (parent- or child-report versions): 8 or more
SCAS (Child-report):
For male children: Scores of 48 or more.
For female children: Scores of 51 or more.
SCAS (Parent-report):
For male children: Scores of 24 or more.
For female children: Scores of 26 or more.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When parents submit their baseline assessment on the trial website, the website will generate an automated random allocation sequence to allocate parent-adolescent dyads to either the control or intervention group. Parents find out their assignment immediately thereafter: the intervention group receives their tailored feedback, the Parenting Guidelines, and the online parenting program comprising up to 9 modules which are recommended based on their survey responses; whereas the control group receive the first of their five weekly factsheets. As such, allocation is concealed from both participants and researchers prior to assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial website is programmed to run a random allocation sequence to allocate parent-adolescent dyads to either the control or intervention group, immediately after parents submit their baseline assessment online.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
"The people administering the treatment/s" are "masked" because the intervention is delivered online by a fully automated trial website.

Child informants ("people assessing the outcomes") are assumed to be blinded because they are not direct recipients of the web-based parenting intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main analyses will be intent-to-treat. To assess group differences in changes in parental concordance with the Guidelines (primary outcome 1) and adolescent depression and anxiety symptoms (secondary outcomes) across timepoints (baseline, 3 month and 12 month follow-up), Mixed effect Model Repeated Measures (MMRM) analyses will be conducted.
Moderation analyses will be conducted to assess whether the primary and secondary outcomes are moderated by adolescent age and gender, and baseline symptom levels. The moderation analyses will be conducted within MMRM, with moderator variables entered into separate models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2015
Actual
21/08/2015
Date of last participant enrolment
Anticipated
Actual
15/10/2016
Date of last data collection
Anticipated
22/12/2017
Actual
3/12/2017
Sample size
Target
676
Accrual to date
Final
702
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA

Funding & Sponsors
Funding source category [1] 291012 0
Charities/Societies/Foundations
Name [1] 291012 0
Australian Rotary Health
Country [1] 291012 0
Australia
Primary sponsor type
Individual
Name
Dr Marie Yap
Address
Dr Marie Yap
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton, 3800
Victoria
Country
Australia
Secondary sponsor category [1] 289688 0
None
Name [1] 289688 0
Address [1] 289688 0
Country [1] 289688 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292596 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 292596 0
Ethics committee country [1] 292596 0
Australia
Date submitted for ethics approval [1] 292596 0
15/12/2014
Approval date [1] 292596 0
30/01/2015
Ethics approval number [1] 292596 0
CF14/3887 - 2014002024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 374 374 0 0
/AnzctrAttachments/368274-2014002024 MUHREC Approval.pdf

Contacts
Principal investigator
Name 56154 0
Dr Marie Yap
Address 56154 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton Victoria 3800
Country 56154 0
Australia
Phone 56154 0
+61 3 9905 0723
Fax 56154 0
Email 56154 0
[email protected]
Contact person for public queries
Name 56155 0
Marie Yap
Address 56155 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton Victoria 3800
Country 56155 0
Australia
Phone 56155 0
+61399050723
Fax 56155 0
Email 56155 0
[email protected]
Contact person for scientific queries
Name 56156 0
Marie Yap
Address 56156 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton Victoria 3800
Country 56156 0
Australia
Phone 56156 0
+61 3 9905 0723
Fax 56156 0
Email 56156 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMedium-Term Effects of a Tailored Web-Based Parenting Intervention to Reduce Adolescent Risk of Depression and Anxiety: 12-Month Findings From a Randomized Controlled Trial.2019https://dx.doi.org/10.2196/13628
N.B. These documents automatically identified may not have been verified by the study sponsor.