Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000366651
Ethics application status
Approved
Date submitted
21/03/2023
Date registered
13/04/2023
Date last updated
13/04/2023
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the National Roll-out of the Triple P Online System
Scientific title
Efficacy of the National Roll-out of the Triple P Online System in parents of children aged 0-12.
Secondary ID [1] 309371 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behaviour and emotional adjustment 328974 0
Child anxiety 328975 0
Parenting children with anxiety 328976 0
Parenting babies 328977 0
Condition category
Condition code
Mental Health 325960 325960 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will take advantage of a roll-out of The Triple P Online System (TPOS) within Australia which has been funded for dissemination to all eligible Australian parents by the Commonwealth Government’s Parenting and Education Support Program from 2022. The TPOS is a web-based platform that provides parents with access to one of three Positive Parenting Programs (Triple P); Triple P Online (TPOL), Fear-Less Triple P Online (FLTPOL), and Triple P Online for Baby (TPOLB). Each of the three Triple P programs provides parents with a range of resources and tools, including interactive modules, videos, and self-help materials, to support their parenting journey. Each of the three Triple P programs contains seven or eight self-paced modules, with each module taking approximately 30 minutes to complete. Participants will have access to the TPOS for 12 months from enrolment, however, for the purposes of this study, observation will only occur for 6 months after enrolment.

Triple P Online (TPOL) - Includes eight self-paced modules that cover topics such as managing difficult behaviour, building strong relationships with children, promoting positive behaviour, and dealing with common childhood issues.

Fear-Less Triple P Online (FLTPOL) - Includes seven self-paced modules that helps parents to manage their child's anxiety and become more resilient. Specific module topics include understanding anxiety and avoidance, promoting emotional resilience, and responding to children's anxiety.

Triple P Online for Baby (TPOLB) - Designed to support parents with babies and includes seven self-paced modules. Topics include promoting positive development, survival skills for new parents, and managing common problems that occur within the early years such as sleeping and crying.
Intervention code [1] 325408 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333807 0
Parenting confidence as measured by in-program efficacy questions (custom measures designed specifically for the program).
Timepoint [1] 333807 0
Assessed immediately prior to the start of each module that is commenced within 6 months after enrolment (the specified period of observation).
Primary outcome [2] 333844 0
For Triple P Online (TPOL) - Parenting practices, parent adjustment and family functioning as measured by the The Parenting and Family Adjustment Scale
Timepoint [2] 333844 0
Baseline, 10 weeks after starting intervention (primary timepoint), 6-month follow-up
Primary outcome [3] 334357 0
For Fear-Less Triple P Online (FTPOL) - Use of anxiety-enhancing parenting strategies as measured by The Parenting an Anxious Child Questionnaire
Timepoint [3] 334357 0
Baseline, 10 weeks after starting intervention (primary timepoint), 6-month follow-up
Secondary outcome [1] 418457 0
For Triple P Online (TPOL) - Child behaviour, as assessed using the Child Adjustment and Parent Efficacy Scale
Timepoint [1] 418457 0
Baseline, 10 weeks after starting intervention, 6-month follow-up
Secondary outcome [2] 418458 0
For Fear-Less Triple P Online (FTPOL) - Child anxiety as measured by The Brief Spence Children’s Anxiety Scale for parents
Timepoint [2] 418458 0
Baseline, 10 weeks after starting intervention, 6-month follow-up
Secondary outcome [3] 418459 0
For Triple P Online for Baby (TPOLB) - Parental depression during the perinatal period as measured by The Edinburgh Postnatal Depression Scale
Timepoint [3] 418459 0
Baseline, 10 weeks after starting intervention, 6-month follow-up
Secondary outcome [4] 420374 0
PRIMARY OUTCOME: For Triple P Online for Baby (TPOLB) - Parental confidence in dealing with common challenges that occur in babies as measured by the The Baby Behaviour Inventory
Timepoint [4] 420374 0
Baseline, 10 weeks after starting intervention (primary timepoint), 6-month follow-up

Eligibility
Key inclusion criteria
Parents of children aged between 0 and 12 years, living in Australia who access and register for the national roll out of Triple P Online System. Emphasis on adequate representation of Indigenous Australians and parents from CALD and LGBTQI+ populations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose
Duration
Longitudinal
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/04/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313152 0
Commercial sector/Industry
Name [1] 313152 0
Triple P International
Country [1] 313152 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 315350 0
Commercial sector/Industry
Name [1] 315350 0
Triple P International
Address [1] 315350 0
11 Market Street
Indooroopilly QLD 4068
Country [1] 315350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312392 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 312392 0
Cumbrae-Stewart Building
The University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 312392 0
Australia
Date submitted for ethics approval [1] 312392 0
Approval date [1] 312392 0
06/12/2022
Ethics approval number [1] 312392 0

Summary
Brief summary
Research Aims:
1. To determine the effectiveness of the Triple P Online System (TPOS) and each individual TPOS variant (Triple P Online, Fear-Less Triple P, Triple P for Baby) on child and parent outcomes.
2. To examine the relationship between pre-intervention characteristics (moderators) and program outcomes (child and parent effects, module completion, and program satisfaction).
3. To identify predictors of responders and non-responders to TPOS interventions at each stage of the engagement and completion process (commencing the programs, completion of within-module activities, module completion and program completion).

The Triple P Online System has been disseminated in Australia since 2014 and randomized controlled trials have shown that the system is effective in improving parenting practices, enhancing parenting efficacy and reducing child behavioural and emotional problems. Little is known however about its efficacy in a practice-as-usual context and about parents’ interaction with the program and the mediators and moderators that influence program outcomes.

This study will take advantage of a roll-out of TPOS within Australia to collect data on effectiveness in a practice-as-usual context. The TPOS system has been funded for dissemination to all eligible Australian parents by the Commonwealth Government’s Parenting and Education Support Program from 2022. Continuous tracking of program outcomes embedded within the Triple P Online System interventions, will provide an ongoing quality management and improvement process. A mix of routinely collected Triple P Online System (TPOS) process data, mapped against parent and child characteristics and parent questionnaire responses pre, during and post program completion will track program effectiveness and allow rapid identification of specific areas for improvement. Tracking of module-by-module parent progress and program use will enable us to identify specific program components that are especially effective and engaging, as well as any that are less engaging and effective for parents.
Trial website
Trial related presentations / publications
Public notes
https://www.triplep-parenting.net.au/ (intervention website)

Contacts
Principal investigator
Name 124502 0
A/Prof Alina Morawska
Address 124502 0
Parenting and Family Support Centre
School of Psychology
University of Queensland
13 Upland Road
ST LUCIA QLD 4072
Country 124502 0
Australia
Phone 124502 0
+61 7 336 57304
Fax 124502 0
Email 124502 0
alina@psy.uq.edu.au
Contact person for public queries
Name 124503 0
A/Prof Alina Morawska
Address 124503 0
Parenting and Family Support Centre
School of Psychology
University of Queensland
13 Upland Road
ST LUCIA QLD 4072
Country 124503 0
Australia
Phone 124503 0
+61 7 336 57304
Fax 124503 0
Email 124503 0
alina@psy.uq.edu.au
Contact person for scientific queries
Name 124504 0
A/Prof Alina Morawska
Address 124504 0
Parenting and Family Support Centre
School of Psychology
University of Queensland
13 Upland Road
ST LUCIA QLD 4072
Country 124504 0
Australia
Phone 124504 0
+61 7 336 57304
Fax 124504 0
Email 124504 0
alina@psy.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.