Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001602819
Ethics application status
Approved
Date submitted
5/10/2021
Date registered
24/11/2021
Date last updated
25/10/2022
Date data sharing statement initially provided
24/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Triple P Positive Parenting Program for Kisumu: What is the effect on parental behaviours.
Scientific title
The impact of Group Triple P on the use of corporal punishment among parents in Kenya.
Secondary ID [1] 305000 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record
na

Health condition
Health condition(s) or problem(s) studied:
Negative parent-child internations 322527 0
Behavioural problems in children 322529 0
Condition category
Condition code
Public Health 320752 320752 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group Triple P Positive Parenting Progam (GTP) is an 8 session parenting program comprising of 4 group sessions (2-3 hours) plus 4 individual sessions delivered by phone or in-person (30 minutes) to provide tailored support. The program will be delivered such that the group sessions will be delivered over two days where Sessions 1 & 2 will be delivered on the first day and sessions 3-4 will be delivered on the second day a week later. The follow-up sessions will be delivered via phone or in-person depending one week apart.

During the group sessions parenting, information will be delivered using a variety of techniques including PowerPoint, group discussion, interactive role-playing exercises, and video presentation. Concepts are consolidated during individual reflective exercises and in group-based exercises and discussions. The video content lasts approximately 50 minutes which is spread over the four group sessions. Parents will be provided with a parenting workbook that summarises all content and which they can complete the written exercises during the group sessions. During the individual sessions, no further formal content is provided however the facilitator and the parent will reflect on content presented in previous sessions.

Parents will be encouraged to complete homework tasks focused on the implementation of new parenting strategies. For example, a parent may choose to set a goal of trying to praise a certain behavior every day. As such the time required for homework activities can vary depending on which strategies the parents choose to implement but constitute a part of general parenting activities. The vast majority of homework tasks do not involve specific exercises from the workbook with the exception of homework related to tracking children's behaviour which may take 2-3 minutes per day and the development of a parenting plan which may take 10-15 minutes in total.

Program content draws on the theoretical principles that form the basis of the well-established Triple P program, which is a preventively orientated parenting and family support strategy derived from social-learning, functional analysis, and cognitive-behavioural principles. Parents are taught a range of positive parenting strategies focused on how to teach children new skills, encourage positive behaviour and how to manage problem behaviour with the goal of improving parent and child behaviour via direct (eg changing parenting style) and indirect (enhancing parental confidence) pathways. The program will be delivered by a trained and accreditated Triple P provider. Protocol adherence will be measured by a checklist completed by the practitioner.

Parents will receive a Triple P Group workbook and will view the Triple P Every Parent Survival Guide DVD as part of the intervention during the group sessions.
Intervention code [1] 321397 0
Behaviour
Comparator / control treatment
Participants in Waitlist Control Condition do not receive any active condition until following the time three data collection point when they will receive the Group Triple P Program. They may have access to other parenting support via community charity organizations.
Control group
Active

Outcomes
Primary outcome [1] 328039 0
Any change changes in the use of corporal punishment using a variation of the MICS corporal punishment questions.
Timepoint [1] 328039 0
Baseline, immediately post-intervention (10 weeks post-enrollment, primary endpoint), and 12 months post-enrollment.
Secondary outcome [1] 397312 0
Changes in parenting confidence using a purpose-built scale.
Timepoint [1] 397312 0
Baseline, immediately post-intervention (10 weeks post-enrollment, and 12 months post-enrollment.
Secondary outcome [2] 397313 0
Changes in the use of dysfunctional parenting styles using the Parenting Scale.
Timepoint [2] 397313 0
Baseline, immediately post-intervention (10 weeks post-enrollment, and 12 months post-enrollment.
Secondary outcome [3] 399590 0
Changes in levels of child behaviour problems using the Strengths and Difficulties Questionnaire.
Timepoint [3] 399590 0
Baseline, immediately post-intervention (10 weeks post-enrollment and 12 months post-enrollment.

Eligibility
Key inclusion criteria
Being a primary carer of a child age 2-12 years of age (the primary carer must live with the child)

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The child has been a diagnosed with a serious mental or developmental disorder health condition (as reported by the parent).
The caregiver is currently receiving other parenting support (at the time of recruitment only)
Not having basic literacy (as defined by the ability to read at grade 5 level).
Inability to attend the group sessions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who was "off-site" or at the central administration site. Allocation will be concealed from the person recruiting parents until assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants in Waitlist Control Condition do not receive any active condition until following the time three data collection point when they will receive the Group Triple P Program. They may have access to other parenting support via community charity organizations.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum of 150 caregivers will be recruited, Power was calculated based on previous Triple P Trials using child behaviour as the focal variable. No data exists to estimate effect size of the intervention on corporal punishment. A moderate effect size is anticipated.

The data collected from this randomised controlled trial will be analysed by using SPSS. Mixed between-within MANOVA and a series of ANOVAs or ANOVCA will be conducted to compare differences in the dependent variables between conditions (the Triple P intervention versus the Waitlist control group) and times (pre-intervention, post-intervention, and 6-month follow up). Descriptive statistics will be carried out to explore parents’ satisfaction with the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
21/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
60
Final
Recruitment outside Australia
Country [1] 23846 0
Kenya
State/province [1] 23846 0
Kisumu

Funding & Sponsors
Funding source category [1] 308973 0
University
Name [1] 308973 0
Alexander von Humboldt Foundation via University of Konstanz
Country [1] 308973 0
Germany
Primary sponsor type
University
Name
University of Konstanz
Address
Universitätsstrasse 10
78464 Konstanz - Germany
Country
Germany
Secondary sponsor category [1] 310390 0
None
Name [1] 310390 0
Address [1] 310390 0
Country [1] 310390 0
Other collaborator category [1] 281874 0
University
Name [1] 281874 0
The University of Queensland
Address [1] 281874 0
Parenting and Family Support Centre
University of Queensland
St Lucia, Brisbane, QLD, 4072
Country [1] 281874 0
Australia
Other collaborator category [2] 281936 0
Charities/Societies/Foundations
Name [2] 281936 0
Child Awareness Development and Management Initiative (CADAMIC)
Address [2] 281936 0
P. O. Box 19221;
Nyerere Road
Kisumu, Kenya, Code 40123
Country [2] 281936 0
Kenya

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308865 0
Ethik-Kommission at University of Konstanz
Ethics committee address [1] 308865 0
Ethics committee country [1] 308865 0
Germany
Date submitted for ethics approval [1] 308865 0
27/08/2021
Approval date [1] 308865 0
05/10/2021
Ethics approval number [1] 308865 0
36/2021
Ethics committee name [2] 309221 0
Jaramogi Oginga Odinga Ethics Committee Teaching and Referral Hospital
Ethics committee address [2] 309221 0
Ethics committee country [2] 309221 0
Kenya
Date submitted for ethics approval [2] 309221 0
30/09/2021
Approval date [2] 309221 0
29/10/2021
Ethics approval number [2] 309221 0
419188

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

Contacts
Principal investigator
Name 112150 0
Prof Anke Hoeffler
Address 112150 0
University of Konstanz
Universitätsstrasse 10
78464 Konstanz
Country 112150 0
Germany
Phone 112150 0
+49 7531 884801
Fax 112150 0
Email 112150 0
anke.hoeffler@uni-konstanz.de
Contact person for public queries
Name 112151 0
Anke Hoeffler
Address 112151 0
University of Konstanz
Universitätsstrasse 10
78464 Konstanz
Country 112151 0
Germany
Phone 112151 0
+49 7531 884801
Fax 112151 0
Email 112151 0
office.hoeffler@uni-konstanz.de
Contact person for scientific queries
Name 112152 0
Divna Haslam
Address 112152 0
Parenting and Family Support Centre
The University of Queensland
Brisbane QLD
Australia 4072
Country 112152 0
Australia
Phone 112152 0
+61 07 3346 7553
Fax 112152 0
Email 112152 0
d.haslam@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data, after removal of sensitive variables from the data set
When will data be available (start and end dates)?
Following publication of trial results; no end date is determined
Available to whom?
Data will be made available to researchers only on the condition of approval from the original research team.
Available for what types of analyses?
Data collected for this project may be used by the research team or by other researchers for research that is related to the current project.
How or where can data be obtained?
Data can be accessed by contacting the Principal Investigator directly via email at anke.hoeffler@uni-konstanz.de


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.