Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623001009606
Ethics application status
Approved
Date submitted
31/08/2023
Date registered
18/09/2023
Date last updated
18/09/2023
Date data sharing statement initially provided
18/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Efficacy of Brief Seminar Triple P to Promote Parent and Child Self-Regulation in Indonesia
Scientific title
Evaluation of the Efficacy of Brief Seminar Triple P to Promote Parent and Child Self-Regulation in Indonesia
Secondary ID [1] 310503 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
parent self-regulation 331300 0
child self-regulation 331301 0
Condition category
Condition code
Mental Health 328061 328061 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION NAME: Selected Triple P (Positive Parenting Programme) parenting intervention in the format of three brief seminars (each 90 minutes) over three weeks.

RATIONALE: While mainly this study is about self-regulation, Triple P used as the intervention due to its reputation for using the self-regulatory approach in the intervention delivery. However, given this claim and the importance of self-regulation, the efficacy of parenting intervention (including Triple P) in promoting parent and child self-regulation remains untested.

TEAM: The intervention will be delivered by one of the research teams that has been accredited in delivering this specific intervention program (i.e., Selected Triple P). She is also an Indonesian psychologist and a PhD fellow at the Parenting and Family Support Centre, University of Queensland. This study is supervised by the experts in this field, which are senior researchers at the Parenting and Family Support Centre, University of Queensland.

MATERIAL: All the materials (e.g., presentation slides, tip sheet) and seminar process are standardized and provided by Triple P International as the licence holder of Triple P. An adherence checklist is provided to ensure the fidelity of the intervention delivery. A research assistant will observe and check the adherence to the seminar protocol. This study will use measures to assess demographics, parent and child self-regulation, parenting practice and child behaviour.
The seminar series includes The Power of Positive Parenting, Raising Confident, Competent Children, and Raising Resilient Children (Sanders, 2012). The following are the brief description about each theme:
a. The Power of Positive Parenting
This session will present the challenges of being a parent, what positive parenting is, why parents and children need it, and how to apply it in daily practice.
b. Raising Confident, Competent Children
The second seminar will discuss some life skills that children need for future success, such as showing respect to others, being considerate, having good communication and social skills, having healthy self-esteem, developing problem-solving skills, and becoming independent. The presenter will present ideas on how parents can encourage these skills with their children.
c. Raising Resilient Children
The last seminar will highlight emotional resilience in children, including what it means, why it is important, and how parents can promote it at home. TIME: The seminars will be delivered once a week, with a 90-minute duration each. The study will be conducted in December 2023.

LOCATION: This study will be conducted in Medan City, North Sumatera Province, Indonesia. The venue will be a seminar room in a government-owned office.

PROCEDURE: Participant recruitment will be online. Eligible participants allocated to two groups, the intervention and the control group, with stratified random assignment to ensure an even sample composition based on gender, education, and economic status. All participants will fill out the online questionnaire as a baseline assessment. Then, the intervention group will receive three classroom seminars in person, each 90 minutes long. In each week, participants will receive a tip sheet for each of the seminar’s theme. The delivery mode is mainly by slide presentation and involves some individual reflection. Subsequently, participants will undertake three assessments online (post-intervention, after three months and after six months).
Meanwhile, the control group will not receive the seminars but undertake the same follow-up assessments. They will receive the same seminars after completing all the assessments for control group compensation. The seminar for the control group will be conducted online. All the questionnaires for the control group will be distributed in an online form, too.
Intervention code [1] 326896 0
Behaviour
Comparator / control treatment
The control group will not receive the seminars (no treatment) but will undertake the same follow-up assessments. They will receive the same seminars after completing all the assessments for control group compensation. The seminar for the control group will be conducted online. All the questionnaires will be distributed in online form.
Control group
Active

Outcomes
Primary outcome [1] 335929 0
Parent self-regulation will be assessed by 16-item Me as a Parent Scale (MaaP)
Timepoint [1] 335929 0
1. Baseline (two weeks before the seminars)
2. Post-completion of seminar program (one week after the completion of the seminars)
3. Three-month follow-up after the completion of the seminars
4. Six-month follow-up after the completion of the seminars
Primary outcome [2] 335930 0
Child self-regulation will be assessed by 19 items of the Child Self-Regulation Scale (CSRS).
Timepoint [2] 335930 0
1. Baseline (two weeks before the seminars)
2. Post-completion of seminar program (one week after the completion of the seminars)
3. Three-month follow-up after the completion of the seminars
4. Six-month follow-up after the completion of the seminars
Primary outcome [3] 336027 0
Parent Self-Regulation will be assessed by the 12 -item of the Parent Self-Regulation Scale (PSRS)
Timepoint [3] 336027 0
1. Baseline (two weeks before the seminars)
2. Post-completion of seminar program (one week after the completion of the seminars)
3. Three-month follow-up after the completion of the seminars
4. Six-month follow-up after the completion of the seminars
Secondary outcome [1] 426171 0
Child behaviour will be assessed by the Child Adjustment and Parent Efficacy Scale (CAPES)-Child Intensity sub-scale.
Timepoint [1] 426171 0
1. Baseline (two weeks before the seminars)
2. Post-completion of seminar program (one week after the completion of the seminars)
3. Three-month follow-up after the completion of the seminars
4. Six-month follow-up after the completion of the seminars
Secondary outcome [2] 426172 0
Parenting practice will be assessed by 30 items of Parenting and Family Adjustment Scale (PAFAS)
Timepoint [2] 426172 0
1. Baseline (two weeks before the seminars)
2. Post-completion of seminar program (one week after the completion of the seminars)
3. Three-month follow-up after the completion of the seminars
4. Six-month follow-up after the completion of the seminars

Eligibility
Key inclusion criteria
- Indonesian parents (biological/adopted) with a typically developing child aged 3-12 years.
- Have been living together in the same house for at least the last six months and plan to continue living with the child for at least the next six months.
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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will apply stratified random assignment to ensure an even sample composition based on gender, education, and economic status. The free online randomize software (e.g. www.randomizer.org) will be used to help randomly assigned participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size is 100 participants for each intervention and control group. Univariate and multivariate analyses of variance will be used to test the intervention effect. In addition, we will use a multi-domain latent growth model to investigate the trajectory of parent and child self-regulation from multiple time measurements.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/12/2023
Actual
Date of last participant enrolment
Anticipated
23/12/2023
Actual
Date of last data collection
Anticipated
29/06/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 25736 0
Indonesia
State/province [1] 25736 0
Medan, North Sumatera

Funding & Sponsors
Funding source category [1] 314704 0
Government body
Name [1] 314704 0
Indonesia Endowment Fund for Education (known as LPDP)
Country [1] 314704 0
Indonesia
Funding source category [2] 314707 0
University
Name [2] 314707 0
University of Queensland
Country [2] 314707 0
Australia
Primary sponsor type
Individual
Name
A/Prof Alina Morawska
Address
Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country
Australia
Secondary sponsor category [1] 316676 0
Individual
Name [1] 316676 0
Dr April Hoang
Address [1] 316676 0
Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country [1] 316676 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313780 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 313780 0
Ethics committee country [1] 313780 0
Australia
Date submitted for ethics approval [1] 313780 0
22/06/2023
Approval date [1] 313780 0
06/07/2023
Ethics approval number [1] 313780 0
2023/HE000947

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

Contacts
Principal investigator
Name 129122 0
A/Prof Alina Morawska
Address 129122 0
Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country 129122 0
Australia
Phone 129122 0
+61 0733657290
Fax 129122 0
Email 129122 0
[email protected]
Contact person for public queries
Name 129123 0
Olifa Asmara
Address 129123 0
Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country 129123 0
Australia
Phone 129123 0
+61 452353825
Fax 129123 0
Email 129123 0
[email protected]
Contact person for scientific queries
Name 129124 0
Olifa Asmara
Address 129124 0
Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country 129124 0
Australia
Phone 129124 0
+61 452353825
Fax 129124 0
Email 129124 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


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.