Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000852651
Ethics application status
Approved
Date submitted
25/07/2023
Date registered
8/08/2023
Date last updated
8/08/2023
Date data sharing statement initially provided
8/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Thriving Kids and Parents Schools Project: Protocol of an Incomplete Stepped Wedged Cluster Randomised Trial Evaluating the Effectiveness of a Triple P Seminar Series
Scientific title
The Thriving Kids and Parents Schools Project: Protocol of an Incomplete Stepped Wedged Cluster Randomised Trial Evaluating the Effectiveness of a Triple P Seminar Series for Parents of Primary School Aged Children
Secondary ID [1] 310183 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inappropriate child behaviour 330775 0
Child anxiety 330776 0
Peer victimisation 330777 0
Suboptimal parenting practices 330778 0
Condition category
Condition code
Mental Health 327621 327621 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention used in the present study consists of three Triple P – Positive Parenting Program seminars. The Thriving Kids and Parents Schools Project (TKPSP) seminar series is a universal offer designed for all parents and likely to be of particular interest to parents who are generally coping well but having some concerns about aspects of their child’s social or emotional development or have parenting concerns and are seeking further information and support. Seminars will be delivered by experienced, accredited Triple P practitioners online via videoconferencing software and each seminar takes about 90 to 120 minutes to complete, including Q&A time. The seminars are in presentation format with video components. Practitioners use session checklists to make sure they are adhering the intervention requirements. The three interconnected seminars focus on an important set of strategies to help parents support their child’s development and help them thrive now and into adolescence. For each step, parents will be given a six-week window to attend seminars on weekly or fortnightly basis until their post-intervention survey is due. Seminars in the TKPSP series cover the following topics:
• The Power of Positive Parenting seminar provides the building blocks for the Triple P program (Sanders et al., 2009). It introduces the five core principles of positive parenting, assists parents to understand children’s behaviour and introduces practical strategies to support children’s social and emotional development.
• The Helping Your Child to Manage Anxiety seminar is a light-touch version of the Fearless Triple P program (Cobham et al., 2017). This seminar is designed to equip parents with the skills and strategies needed to support children to manage their emotions and overcome challenges.
• The Keeping your Child Safe from Bullying seminar is developed as the low-intensity version of the Resilience Triple P program (Healy & Sanders, 2014). This seminar provides parents with strategies to maintain good communication with their children, develop positive peer relationships, and address conflict and bullying.
Intervention code [1] 326582 0
Prevention
Intervention code [2] 326583 0
Behaviour
Comparator / control treatment
The control group will receive the intervention 6 weeks later than the intervention condition.
Control group
Active

Outcomes
Primary outcome [1] 335446 0
Child Adjustment and Parent Efficacy Scale (CAPES)
Children’s social, emotional, and behavioural difficulties
This will be assessed as a composite outcome
Timepoint [1] 335446 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline, primary endpoint)
Primary outcome [2] 335447 0
Parenting and Family Adjustment Scale (PAFAS)
It will be used to assess parenting practices
This will be assessed as a composite outcome
Timepoint [2] 335447 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline, primary endpoint)
Primary outcome [3] 335448 0
Parenting Self-regulation Scale (PSRS)
It will be used to assess parents’ self-regulatory capacity (self-efficacy) in their parenting role.
Timepoint [3] 335448 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline, primary endpoint)
Secondary outcome [1] 424587 0
Parenting an Anxious Child Questionnaire (PACQ)
It is used to assess parental responses and confidence in managing children’s anxiety.
This will be assessed as a composite outcome
Timepoint [1] 424587 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline)
Secondary outcome [2] 424588 0
Brief Spence Children’s Anxiety Scale (BSCAS)
For child anxiety symptoms.
Timepoint [2] 424588 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline)
Secondary outcome [3] 424589 0
The Preschool Feelings Checklist (PFC)
For children depression symptoms
Timepoint [3] 424589 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline)
Secondary outcome [4] 424590 0
The Partners in Education Survey (PIES)
It is a parent-report measure the Home-School Partnership for parents of children ages 5 to 12 years attending primary school.
Timepoint [4] 424590 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline)
Secondary outcome [5] 424591 0
The Parent Satisfaction Survey (PSS)
It evaluates parents’ perceptions of the overall quality of the Triple P seminar series.
Timepoint [5] 424591 0
T2 (week 6 post baseline)
Secondary outcome [6] 425224 0
Child Adjustment and Parent Efficacy Scale (CAPES)
Parents’ confidence (self-efficacy) in managing the parenting challenges.

This is a primary outcome.
Timepoint [6] 425224 0
T1 (baseline); T2 (week 6 post baseline); T3 (week12 post baseline, primary endpoint)

Eligibility
Key inclusion criteria
Parents’ eligibility will be determined using the following inclusion criteria: 1) presence in the family of at least one child of primary-school-age; 2) interested in information about parenting and child development; 3) able to attend seminars on three separate occasions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Allocation is concealed through central randomisation by computer using the Minirand Package in R Studio (Jin et al., 2021).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following an expression of interest in participating in the project, schools within each batch of schools will be randomly allocated to either the start now condition or the start later condition. Random allocation will be conducted on an ongoing basis throughout the trial via a process of Minimisation (with a random component), which aims to achieve the optimal balance of school characteristics between the two study arms throughout the trial. Schools will be randomised in a 1:1 ratio, with a random component (p = .80), using the Minirand Package in R Studio (Jin et al., 2021). The project team cannot manipulate the sequence of randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The evaluation will employ an Incomplete Batched Stepped Wedge Cluster Randomised Trial Design. For the present study, schools will be recruited in three batches, with approximately 100 schools in each batch. Within each wave, schools will subsequently be randomly allocated to: 1) receiving the seminar package immediately (start now); or 2) receiving seminars 6 weeks later (start later). The next batch will start six weeks after the previous batch starts. The evaluation will employ a quantitative online survey method with data collected from all participants before the intervention starts, six weeks after the initial assessment (Time 2), and 12 weeks after initial assessment (Time 3).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The patterns of the data missingness will be tested and appropriately addressed prior to the analysis of outcome variables. If the missingness is deemed to be Missing Completely at Random or Missing at Random, Full-information Maximum Likelihood (FIML) estimation or expectation maximisation algorism (EM) will be used to impute the missing data (Bennett, 2001). Following an intention-to-treat protocol, a Piecewise Latent Growth Curve Model (Piecewise LGCM) will be tested for each outcome variable, which allows the estimation of the rate of change between the pre-intervention assessment and the post-intervention assessment and the rate of change between the post-intervention assessment and the follow-up assessment. If the school level variance is substantial due to the nested nature of sample, a multi-level Piecewise LGCM will be used. School and individual level control variables might be included in the model (see Figure 2 for the proposed model). To examine the differences between conditions, appropriate analytic options for the present study design will include but not limit to multigroup ML-Piecewise LGCM and visual analysis using Brinley Plots (Blampied, 2017).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/05/2023
Date of last participant enrolment
Anticipated
15/11/2023
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
5000
Accrual to date
1200
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 314350 0
Government body
Name [1] 314350 0
The Australian Government Department of Education, Skills and Employment
Country [1] 314350 0
Australia
Primary sponsor type
Government body
Name
The Australian Government Department of Education, Skills and Employment
Address
Department of Education
GPO Box 9880
Canberra ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 316297 0
None
Name [1] 316297 0
Address [1] 316297 0
Country [1] 316297 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313446 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 313446 0
Ethics committee country [1] 313446 0
Australia
Date submitted for ethics approval [1] 313446 0
05/07/2022
Approval date [1] 313446 0
14/10/2022
Ethics approval number [1] 313446 0
2022/HE001114

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128190 0
Prof Christopher Boyle
Address 128190 0
Nexus 10, floor 8
School of Education
The University of Adelaide (Adelaide)
230 North Tce
AUSTRALIA SA 5005
Australia
Country 128190 0
Australia
Phone 128190 0
+61 8 83134397
Fax 128190 0
Email 128190 0
[email protected]
Contact person for public queries
Name 128191 0
Christopher Boyle
Address 128191 0
Nexus 10, floor 8
School of Education
The University of Adelaide (Adelaide)
230 North Tce
AUSTRALIA SA 5005
Australia
Country 128191 0
Australia
Phone 128191 0
+61 8 83134397
Fax 128191 0
Email 128191 0
[email protected]
Contact person for scientific queries
Name 128192 0
Matthew Sanders
Address 128192 0
Parenting and Family Support Centre,
The University of Queensland
1/13 Upland Road,
St Lucia, QLD 4067
Country 128192 0
Australia
Phone 128192 0
+61 7 336 57290
Fax 128192 0
Email 128192 0
[email protected]

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


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19793Ethical approval    386283-(Uploaded-01-08-2023-11-51-38)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19793Study protocol https://link.springer.com/article/10.1186/s12889-023-16962-4  386283-(Uploaded-01-08-2023-11-51-38)-Study-related document.pdf

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.