Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001309774
Ethics application status
Approved
Date submitted
5/09/2022
Date registered
11/10/2022
Date last updated
28/04/2024
Date data sharing statement initially provided
11/10/2022
Date results information initially provided
28/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
"Healthy Habits Triple P": an online program to support parents to develop healthy screen use habits with young children.
Scientific title
Feasibility, acceptability and efficacy of a novel, brief self-directed online parenting intervention designed to support parents to develop healthy screen use habits with young children.
Secondary ID [1] 307868 0
None
Universal Trial Number (UTN)
U1111-1282-1293
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screen use 327486 0
Condition category
Condition code
Public Health 324609 324609 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will evaluate a brief online parenting support intervention designed to help parents develop the skills and confidence to implement healthy screen use practices with children from the earliest years. "Healthy Habits Triple P" is a novel online intervention that aims to improve parenting skills/confidence and increase parental self-regulation and positive parenting practices to promote child cooperation, lead to consistent discipline and promote routine. Healthy Habits Triple P is designed to be completed flexibly (over multiple sittings, if desired) to reduce barriers to access for parents of young children who are often time-poor or experiencing other life stressors. Parents work through the program at their own pace over a 2-week period.

Module 1: “Getting Started with Healthy Habits” (delivered in 8 sections, approx. 3 hrs total) introduces principles of positive parenting to promote use of positive parenting practices and effective disciplinary methods, and environments conducive to caring relationships between parents and children. It provides parents with strategies to prevent/manage problem behaviours and promote preventive health behaviours with their children. Module 2: “Healthy Screen Use” (approx. 1 hr) introduces strategies aimed at developing healthy screen use with children, including establishing rules and limits around screen use, modelling healthy screen use behaviours, using effective parenting strategies to prevent/manage difficult child behaviour, and identifying high-risk situations that contribute to excessive screen use.

Healthy Habits Triple P is delivered via EdX Edge at The University of Queensland. It is interactive, flexible, and caters to the different needs of parents of children from birth to 5 years. It is designed to be engaging and easy to navigate, and includes interactive features including video/audio clips, goal-setting activities, downloadable monitoring sheets, and progress trackers. Email and SMS prompts and reminders maintain engagement and encourage module completion. Families allocated to the intervention group will be sent an email with EdX registration instructions shortly after randomisation (day 0), followed by a SMS reminder to register (day 1). Any families who have not registered by day 2 will be contacted by phone to check for access difficulties. All intervention group families will be sent SMS reminders to continue working through the program on days 3, 5, 9 and 11. Paired email and SMS reminders will be sent at approximately half-way through the intervention period (day 7) and the end of the intervention period (day 14) to help parents pace their progress through the program and encourage on-time completion. Intervention completion will be monitored via EdX data downloads (website analytics). Any parents who have not completed at least 50% of the program by day 7 will be contacted by phone to check for difficulties with access.
Intervention code [1] 324335 0
Behaviour
Comparator / control treatment
The control group will receive a copy of the Australian Government's "Guidelines for Healthy Growth and Development for Your Child - The Early Years (Birth to 5 Years)" brochure. The control group will be provided with access to the intervention after completing 3-month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 332428 0
Parents' confidence with managing children's screen use as assessed using the Screen Time Self-Efficacy Scale.
Timepoint [1] 332428 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3-month follow-up.
Primary outcome [2] 332445 0
Parents' confidence with managing screen-related child behaviour problems as assessed using the Screen Time Behaviour Checklist.
Timepoint [2] 332445 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3-month follow-up.
Secondary outcome [1] 413457 0
Parenting behaviour, as assessed using the Parenting Scale.
Timepoint [1] 413457 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3-month follow-up.
Secondary outcome [2] 413458 0
Technology-specific parenting behaviour, as assessed using the Technology-Related Parenting Scale.
Timepoint [2] 413458 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3-month follow-up.
Secondary outcome [3] 413459 0
Child behaviour, as assessed using the Screen Time Behaviour Checklist.
Timepoint [3] 413459 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3-month follow-up.
Secondary outcome [4] 413535 0
Children's average daily screen use (hours), as assessed via parent-report on the Children's Screen Time History Questionnaire.
Timepoint [4] 413535 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3-month follow-up.
Secondary outcome [5] 414037 0
Intervention feasibility, indicated by the number of families who access the study website and complete screening, the proportion of participants who access and complete the intervention, and participant retention. Assessed via website analytics and audit of study records.
Timepoint [5] 414037 0
At study completion
Secondary outcome [6] 414038 0
Intervention acceptability, as assessed via the Client Satisfaction Survey
Timepoint [6] 414038 0
4-weeks post-intervention

Eligibility
Key inclusion criteria
Parents of children aged 9 months to 4 years old
Living in Australia
Able to read and understand English
Have access to a device (e.g, PC, laptop, tablet, smartphone) with internet access
Sufficent time to complete the online program over a two-week period
Provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child has a neurodevelopmental condition or disability
Parents already receiving psychological help or counselling for parenting or child behaviour concerns
Parents have previously completed Triple P
Parents unable to read at fifth grade level.

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)
Particpants will be randomised automatically via Qualtrics at completion of the baseline questionnaire, and will be notified of their group allocation via an on-screen message (followed up by an email).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Automated block randomisation within Qualtrics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intent-to-treat analyses using multilevel modelling compare change over time between groups. This pilot trial will require N=70 (two-tailed a=.05, ß=.80), allowing for 40% potential attrition and based on an estimated effect size of d=.5 for the primary outcome (parenting self-efficacy).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2022
Actual
25/11/2022
Date of last participant enrolment
Anticipated
30/11/2022
Actual
9/05/2023
Date of last data collection
Anticipated
28/02/2023
Actual
26/07/2023
Sample size
Target
70
Accrual to date
Final
143
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312143 0
University
Name [1] 312143 0
Griffith University - Centre for Mental Health
Country [1] 312143 0
Australia
Primary sponsor type
Individual
Name
Dr Amy Mitchell
Address
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Road
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 313667 0
Individual
Name [1] 313667 0
A/Prof Alina Morawska
Address [1] 313667 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country [1] 313667 0
Australia
Secondary sponsor category [2] 313668 0
Individual
Name [2] 313668 0
Prof Caroline Donovan
Address [2] 313668 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus
Messines Ridge Rd
Mt Gravatt QLD 4122
Country [2] 313668 0
Australia
Secondary sponsor category [3] 313669 0
Individual
Name [3] 313669 0
A/Prof Leigh Tooth
Address [3] 313669 0
School of Public Health
The University of Queensland
St Lucia QLD 4072
Country [3] 313669 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311537 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 311537 0
Office for Research
Bray Centre (N54) Room 0.10
Griffith University, Nathan Campus
Kessels Road
Nathan QLD 4111
Ethics committee country [1] 311537 0
Australia
Date submitted for ethics approval [1] 311537 0
09/10/2022
Approval date [1] 311537 0
21/10/2022
Ethics approval number [1] 311537 0
2022/758

Summary
Brief summary
The effect of screen use on children’s health and development is now considered a public health issue. National Child Health Polls consistently report excessive screen use as Australian parents’ top-ranked child health concern, and over half of Australian parents are concerned about their own children’s screen use. Parents report that children’s screen use contributes to family conflict, oppositional child behaviour, lack of physical activity, and sleep problems, and data show that high screen use is associated with poorer physical, psychological and developmental health outcomes for children, including in early childhood—relationships which appear to be at least partially mediated by parenting behaviour (e.g., reduced parent-child interaction). Parents report that difficulties with implementing screen use limits, difficult child behaviour when limits are imposed, and parenting practices which encourage screen use are barriers to healthy screen use. Indeed, our own data suggest that difficult child behaviour is a key predictor of low parental self-efficacy for managing children’s screen use which, in turn, predicts greater screen use. This project will evaluate a brief online parenting support intervention designed to help parents develop the skills and confidence to implement healthy screen use practices with children from the earliest years. It will generate essential data to inform study design and applications for funding for a larger scale, fully powered RCT to establish intervention efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121454 0
Dr Amy Mitchell
Address 121454 0
School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, 4072
Country 121454 0
Australia
Phone 121454 0
+61 401 512 035
Fax 121454 0
Email 121454 0
a.mitchell5@uq.edu.au
Contact person for public queries
Name 121455 0
Dr Amy Mitchell
Address 121455 0
School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, 4072
Country 121455 0
Australia
Phone 121455 0
+61 401 512 035
Fax 121455 0
Email 121455 0
a.mitchell5@uq.edu.au
Contact person for scientific queries
Name 121456 0
Dr Amy Mitchell
Address 121456 0
School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, 4072
Country 121456 0
Australia
Phone 121456 0
+61 401 512 035
Fax 121456 0
Email 121456 0
a.mitchell5@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.