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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
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.
Secondary ID [1] 286301 0
None
Universal Trial Number (UTN)
U1111-1167-8374
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. 294388 0
Adolescent depression 294389 0
Adolescent anxiety 294390 0
Condition category
Condition code
Mental Health 294698 294698 0 0
Depression
Mental Health 294699 294699 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291336 0
Behaviour
Intervention code [2] 291337 0
Lifestyle
Intervention code [3] 291338 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 294460 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 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.
Timepoint [1] 294460 0
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.
Secondary outcome [1] 313369 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 [1] 313369 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.
Secondary outcome [2] 313370 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] 313370 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.
Secondary outcome [3] 313402 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 [3] 313402 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

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
Educational / counselling / training
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 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.
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
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2015
Actual
27/05/2015
Date of last participant enrolment
Anticipated
Actual
30/04/2016
Date of last data collection
Anticipated
Actual
17/11/2016
Sample size
Target
680
Accrual to date
Final
678
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290868 0
University
Name [1] 290868 0
Monash University Faculty of Medicine, Nursing and Health Sciences Strategic Grant Scheme
Country [1] 290868 0
Australia
Funding source category [2] 295103 0
Charities/Societies/Foundations
Name [2] 295103 0
Windermere Foundation
Country [2] 295103 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] 289557 0
None
Name [1] 289557 0
Address [1] 289557 0
Country [1] 289557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292478 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 292478 0
Ethics committee country [1] 292478 0
Australia
Date submitted for ethics approval [1] 292478 0
12/12/2014
Approval date [1] 292478 0
30/01/2015
Ethics approval number [1] 292478 0
CF14/3886 - 2014002023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 338 338 0 0
/AnzctrAttachments/368078-2014002023 Approval.pdf

Contacts
Principal investigator
Name 55370 0
Dr Marie Yap
Address 55370 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 55370 0
Australia
Phone 55370 0
+61 3 9905 0723
Fax 55370 0
Email 55370 0
marie.yap@monash.edu
Contact person for public queries
Name 55371 0
Mairead Cardamone-Breen
Address 55371 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 55371 0
Australia
Phone 55371 0
+61 3 9905 1250
Fax 55371 0
Email 55371 0
mairead.cardamone-breen@monash.edu
Contact person for scientific queries
Name 55372 0
Marie Yap
Address 55372 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800
Country 55372 0
Australia
Phone 55372 0
+61 3 9905 0723
Fax 55372 0
Email 55372 0
marie.yap@monash.edu

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
SourceTitleYear of PublicationDOI
EmbaseThe Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders.2017https://dx.doi.org/10.7717/peerj.3825
EmbaseA Single-Session, Web-Based Parenting Intervention to Prevent Adolescent Depression and Anxiety Disorders: Randomized Controlled Trial.2018https://dx.doi.org/10.2196/jmir.9499
N.B. These documents automatically identified may not have been verified by the study sponsor.