ANZCTR - Registration

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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]

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

Child anxiety

Parenting children with anxiety

Parenting babies

Condition category

Condition code

Mental Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Parenting confidence as measured by in-program efficacy questions (custom measures designed specifically for the program).

Timepoint [1]

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]

For Triple P Online (TPOL) - Parenting practices, parent adjustment and family functioning as measured by the The Parenting and Family Adjustment Scale

Timepoint [2]

Baseline, 10 weeks after starting intervention (primary timepoint), 6-month follow-up

Primary outcome [3]

For Fear-Less Triple P Online (FTPOL) - Use of anxiety-enhancing parenting strategies as measured by The Parenting an Anxious Child Questionnaire

Timepoint [3]

Baseline, 10 weeks after starting intervention (primary timepoint), 6-month follow-up

Secondary outcome [1]

For Triple P Online (TPOL) - Child behaviour, as assessed using the Child Adjustment and Parent Efficacy Scale

Timepoint [1]

Baseline, 10 weeks after starting intervention, 6-month follow-up

Secondary outcome [2]

For Fear-Less Triple P Online (FTPOL) - Child anxiety as measured by The Brief Spence Children’s Anxiety Scale for parents

Timepoint [2]

Baseline, 10 weeks after starting intervention, 6-month follow-up

Secondary outcome [3]

For Triple P Online for Baby (TPOLB) - Parental depression during the perinatal period as measured by The Edinburgh Postnatal Depression Scale

Timepoint [3]

Baseline, 10 weeks after starting intervention, 6-month follow-up

Secondary outcome [4]

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]

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]

Commercial sector/Industry

Name [1]

Triple P International

Address [1]

11 Market Street
Indooroopilly QLD 4068

Country [1]

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]

Commercial sector/Industry

Name [1]

Triple P International

Address [1]

11 Market Street
Indooroopilly QLD 4068

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee

Ethics committee address [1]

Cumbrae-Stewart Building
The University of Queensland
St Lucia QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/12/2022

Ethics approval number [1]

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

A/Prof Alina Morawska

Address

Parenting and Family Support Centre
School of Psychology
University of Queensland
13 Upland Road
ST LUCIA QLD 4072

Country

Australia

Phone

+61 7 336 57304

Fax

alina@psy.uq.edu.au

Contact person for public queries

Name

Alina Morawska

Address

Parenting and Family Support Centre
School of Psychology
University of Queensland
13 Upland Road
ST LUCIA QLD 4072

Country

Australia

Phone

+61 7 336 57304

Fax

alina@psy.uq.edu.au

Contact person for scientific queries

Name

Alina Morawska

Address

Parenting and Family Support Centre
School of Psychology
University of Queensland
13 Upland Road
ST LUCIA QLD 4072

Country

Australia

Phone

+61 7 336 57304

Fax

alina@psy.uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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