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Trial registered on ANZCTR
Registration number
ACTRN12615000247572
Ethics application status
Approved
Date submitted
4/03/2015
Date registered
18/03/2015
Date last updated
2/12/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Partners in Parenting: Evaluating a Brief Online Parenting Program
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Scientific title
Examining the effects of a brief individually-tailored web-based parenting program (Partners in Parenting) for parents of 12- to 15-year-olds, compared to a waitlist control condition, on parental risk and protective factors for adolescent depression and anxiety disorders.
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Secondary ID [1]
286301
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None
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Universal Trial Number (UTN)
U1111-1167-8374
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parental risk and protective factors for development of adolescent depression and anxiety disorders.
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Adolescent depression
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Adolescent anxiety
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Condition category
Condition code
Mental Health
294698
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0
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Depression
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Mental Health
294699
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention consists of a brief web-based parenting program ('Partners in Parenting') which is part of a larger research translation program (Parenting Strategies; www.parentingstrategies.net).
Parents will first complete an approximately 20-minute online 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 receive a once-off, individually-tailored feedback report that highlights areas where they are doing well (i.e., concordant with the Guidelines), as well as areas where they can improve (i.e., not concordant with the Guidelines). The messages in the feedback report 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, and will also be emailed a copy of their feedback report as well as the Guidelines.
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Intervention code [1]
291336
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Behaviour
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Intervention code [2]
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Lifestyle
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Intervention code [3]
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Prevention
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Comparator / control treatment
3-month no-treatment waitlist control condition.
Parents in the waitlist control group will receive the intervention (individuall-tailored feedback report) 3 months after their baseline assessment, upon completion of their 3-month follow-up assessment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Parental concordance with the Guidelines 'How to Prevent Depression and Clinical Anxiety in Your Teenager: Strategies for Parents'. This will be assessed by a newly developed parenting survey, 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.
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Assessment method [1]
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Timepoint [1]
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The parenting survey will be completed by both the intervention and control group parents at the following timepoints:
Baseline (pre-intervention)
1 month follow-up (post-intervention)
3 month follow-up.
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Secondary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [2]
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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).
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Assessment method [2]
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Timepoint [2]
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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.
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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Child participants (in the intervention and control group) will complete the child-report parenting survey at the following timepoints:
Baseline
3 month follow-up
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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.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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 brief intervention (tailored feedback), whereas the control group is informed that they will receive their feedback report in 3 months' time. As such, allocation is concealed from both participants and researchers prior to assignment.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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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.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Required sample size:
Based on a power analysis, for a repeated-measures design with a power of 0.80, small effect size, and alpha level of 0.05, a sample size of 294 parent-adolescent dyads (147 dyads per group) is required.
Based on an expected attrition rate of approximately 10-15%, we aim to recruit 340 parent-adolescent dyads (170 dyads per group).
Data analysis:
The main analyses will be intent-to-treat. To assess group differences in changes in parental concordance with the Guidelines (primary outcome) and adolescent depression and anxiety symptoms (secondary outcomes) across timepoints (baseline, 1 month and 3 month follow-up), a series of mixed effects analyses of covariance (ANCOVAs) with missing cell design (to account for parent-only data at 1-month follow-up) will be conducted. Adolescent age and gender will be used as covariates.
Little's MCAR (missing completely at random) test will be used to analyse the extent and pattern of missing data.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/04/2015
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Actual
27/05/2015
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Date of last participant enrolment
Anticipated
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Actual
30/04/2016
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Date of last data collection
Anticipated
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Actual
17/11/2016
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Sample size
Target
680
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Accrual to date
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Final
678
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Monash University Faculty of Medicine, Nursing and Health Sciences Strategic Grant Scheme
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Address [1]
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Monash University
Wellington Road
Clayton
Victoria 3800
Australia
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Windermere Foundation
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Address [2]
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Windermere Foundation LImited
Level 10, 530 Collins Street
Melbourne, VIC, 3000
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Dr Marie Yap
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Address
Dr Marie Yap
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton, 3800
Victoria
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
289557
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Country [1]
289557
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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Monash University Human Research Ethics Committee
Room 111, Building 3e
Monash University
Clayton
Victoria 3800
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
292478
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12/12/2014
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Approval date [1]
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30/01/2015
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Ethics approval number [1]
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CF14/3886 - 2014002023
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Summary
Brief summary
This study aims to evaluate the effects of a brief, individually-tailored web-based parenting program on parenting behaviours associated with adolescent depression and anxiety disorders. The program is designed to provide parents with personalised feedback about their current parenting, including what they are doing well and areas that they can improve in order to reduce their teenager’s risk of depression and anxiety.
We aim to find out whether this program can help improve parenting behaviours associated with adolescent depression and anxiety, and in turn reduce risk of depression and anxiety in teenagers.
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Trial website
http://parentingstrategies.net/depression.brief.intervention/index.php
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Trial related presentations / publications
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Public notes
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Attachments [1]
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/AnzctrAttachments/368078-2014002023 Approval.pdf
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Contacts
Principal investigator
Name
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Dr Marie Yap
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Address
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School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
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Country
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Australia
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Phone
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+61 3 9905 0723
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Mairead Cardamone-Breen
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Address
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School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
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Country
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Australia
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Phone
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+61 3 9905 1250
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Marie Yap
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Address
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School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
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Country
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Australia
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Phone
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+61 3 9905 0723
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Fax
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Email
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A Single-Session, Web-Based Parenting Intervention to Prevent Adolescent Depression and Anxiety Disorders: Randomized Controlled Trial.
2018
https://dx.doi.org/10.2196/jmir.9499
Embase
The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders.
2017
https://dx.doi.org/10.7717/peerj.3825
N.B. These documents automatically identified may not have been verified by the study sponsor.
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