Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001325291
Ethics application status
Approved
Date submitted
1/08/2018
Date registered
7/08/2018
Date last updated
28/06/2021
Date data sharing statement initially provided
18/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of Group Triple P – Positive Parenting Program with Chinese Parents
Scientific title
Facilitating Father Positive Involvement with Children: An Evaluation of Group Triple P – Positive Parenting Program with Chinese Parents
Secondary ID [1] 295668 0
Nil known
Universal Trial Number (UTN)
U1111-1218-2586
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysfunctional parenting behaviors 309057 0
Parenting self-efficacy 309058 0
Child behavioural problems 309060 0
Child emotional problems 309123 0
Condition category
Condition code
Mental Health 307943 307943 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 307944 307944 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Triple P – Positive Parenting Program is an effective evidence-based parenting program, and aims to help parents build strong, healthy relationships, and confidently manage children’s behaviour by providing parents with simple and practical strategies. Group Triple P has been shown to have the positive impact on Chinese parents, which significantly reduced child adjustment problems and ineffective parenting practices, while improving parental self-efficacy (Guo, Morawska, & Sanders, 2016).

Parents in the intervention condition will receive a slightly modified version of Group Triple P. The session content will be tailored slight to have a larger focus on father involvement and partner support, but no major content changes will be included. The program is comprised of four 2-hour group sessions and four 30-minute individual telephone sessions and lasts eight consecutive weeks. One group session per week for 4 weeks followed by one phone session per week for 4 weeks. The four group sessions focused on providing parents skills and strategies needed to manage their children behaviours and support each other in parenting. The four follow-up phone calls were designed to help families tailor the program to the family's needs. During phone call sessions, the weekly goals and homework tasks parents set will be reviewed. Parents can also set the agenda for each of telephone sessions, and discuss problems they encounter and the successes they have with using the positive parenting strategies.

The group sessions will be videotaped for the purpose of ensuring that the intervention is implemented according to the research protocol.

Parents will be provided with Group Triple P workbook and "Supporting Your Partner" Tipsheet. The intervention will be delivered in Chinese (Mandarin). All sessions will be conducted by an accredited provider of the program. The location of the group sessions will be in the local universities or community organizations in China, and will be also based on the preference of the parents.
Intervention code [1] 302004 0
Behaviour
Comparator / control treatment
The control treatment is a wait-list control. Parents in the waitlist control group will be assessed at the same time as the intervention group and will receive the same Group Triple P intervention after completing the assessment at 6-month follow up.
Control group
Active

Outcomes
Primary outcome [1] 306915 0
Father involvement measured using the Father Involvement Questionnaire (Wu et al., 2015)
Timepoint [1] 306915 0
Time 1: Pre-intervention
Time 2: Post-intervention (immediately after the 8 weeks of intervention) [primary timepoint]
Time 3: 6-month follow up
Primary outcome [2] 306916 0
Parenting practices measured using the Parenting and Family Adjustment Scale (PAFAS; Sanders, Morawska, Haslam, Filus, & Fletcher, 2014)
Timepoint [2] 306916 0
Time 1: Pre-intervention
Time 2: Post-intervention (immediately after the 8 weeks of intervention) [primary timepoint]
Time 3: 6-month follow up
Primary outcome [3] 306917 0
Child adjustment measured using the Child Adjustment and Parent Efficacy Scale (CAPES; Morawska, Sanders, Haslam, Filus, & Fletcher, 2014)
Timepoint [3] 306917 0
Time 1: Pre-intervention
Time 2: Post-intervention (immediately after the 8 weeks of intervention)
Time 3: 6-month follow up [primary timepoint]
Secondary outcome [1] 350101 0
Fathering self-efficacy measured using the Child Adjustment and Parent Efficacy Scale (CAPES; Morawska, Sanders, Haslam, Filus, & Fletcher, 2014)
Timepoint [1] 350101 0
Time 1: Pre-intervention
Time 2: Post-intervention (immediately after the 8 weeks of intervention)
Time 3: 6-month follow up
Secondary outcome [2] 350102 0
Parents' beliefs about parental role measured using Beliefs Concerning the Parental Role Scale (BCPR; Bonney, 1997)
Timepoint [2] 350102 0
Time 1: Pre-intervention
Time 2: Post-intervention (immediately after the 8 weeks of intervention)
Time 3: 6-month follow up
Secondary outcome [3] 350103 0
Maternal gate-keeping measured using the Parental Regulation Inventory (PRI; Van Egeren, 2000) to
Timepoint [3] 350103 0
Time 1: Pre-intervention
Time 2: Post-intervention (immediately after the 8 weeks of intervention)
Time 3: 6-month follow up
Secondary outcome [4] 350104 0
Program satisfaction measured using the Client Satisfaction Questionnaire (CSQ; Turner, Markie-Dadds, & Sanders, 2002)
Timepoint [4] 350104 0
Time 2: Post-intervention (immediately after the 8 weeks of intervention)

Eligibility
Key inclusion criteria
The criteria include both parents
1) are willing to participate;
2) have a child who is in preschool, aged 2-6 years old;
3) are Chinese parents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) The child has a physical or intellectual disability (including a developmental disorder and/or chronic illness)
2) The child is currently having regular contact with another professional or agency or taking medication for behavioural problems (as reported by the parent)
3) The parent is currently seeing a professional for parenting support, primarily relating to their child’s behaviour difficulties
4) The parent is receiving psychological/psychiatric help or counselling (personal/marital)
5) The parent is intellectually and/or hearing impaired
6) The parent is not able to read/write Chinese without assistance

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. Participants will be recruited via advertisements. The advertisement will be posted on social media and on the bulletin boards of the preschools and through word of mouth. Parents who are interested in this study can email, send messages or call the researchers to register. They will then receive a telephone screening interview to check if they are eligible. Parents who are eligible and agree to participate will be sent the first questionnaire together with the information sheet and consent form. Randomization to conditions will be conducted after the participants sign the consent form and complete pre-intervention measures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible father-mother dyad will be randomly assigned to either the intervention or control condition by an independent person who is not involved in the study at any stage. The person will use a random number generator to randomly assign the sequence of numbers to two groups. Each father-mother dyad will receive a unique number based on a sequence of consecutive number. The researcher will inform parents of the result by email or phone call.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Eighty-six father-mother dyads will be recruited. The sample size is determined by referring to the guidelines of the selection of sample sizes (VanVoorhis & Morgan, 2007). Given a medium effect size, and 80% power, a minimum of 30 dyads per cell is required to detect group differences (Cohen, 1988). The assumption of the effect size is based on the findings of the Group Triple P Program with additional father-relevant content, which had medium to large effect sizes on fathers to lessen their negative practices and child behavioural problems (Frank, Keown, & Sanders, 2015), and the result of a parent education and support program for fathers, which yielded an effect size of d = .77 for the level of father involvement (Holmes, Galovan, Yoshida, & Hawkins, 2010; McBride, 1991). The determination of the sample size also considers potential attrition of 30%. The relative higher potential attrition is due to the research design of father-mother dyads, which might increase potential attrition.

The data collected from this randomised controlled trial will be analysed by using SPSS. Mixed between-within MANOVA and a series of ANOVAs 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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/08/2018
Actual
30/08/2018
Date of last participant enrolment
Anticipated
31/10/2018
Actual
11/11/2018
Date of last data collection
Anticipated
1/08/2019
Actual
19/07/2019
Sample size
Target
86
Accrual to date
Final
67
Recruitment outside Australia
Country [1] 10711 0
China
State/province [1] 10711 0
Fujian

Funding & Sponsors
Funding source category [1] 300280 0
University
Name [1] 300280 0
School of Psychology, University of Queensland
Country [1] 300280 0
Australia
Primary sponsor type
Individual
Name
Yang Liu
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 299709 0
None
Name [1] 299709 0
Address [1] 299709 0
Country [1] 299709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301071 0
The University of Queensland Human Research Ethics Committee, School of Psychology, Ethics Review Committee
Ethics committee address [1] 301071 0
Ethics committee country [1] 301071 0
Australia
Date submitted for ethics approval [1] 301071 0
02/11/2017
Approval date [1] 301071 0
22/11/2017
Ethics approval number [1] 301071 0
17-PSYCH-PHD-84-AH

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

Contacts
Principal investigator
Name 85782 0
Ms Yang Liu
Address 85782 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 85782 0
Australia
Phone 85782 0
+61 404669568
Fax 85782 0
Email 85782 0
[email protected]
Contact person for public queries
Name 85783 0
Yang Liu
Address 85783 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 85783 0
Australia
Phone 85783 0
+61 404669568
Fax 85783 0
Email 85783 0
[email protected]
Contact person for scientific queries
Name 85784 0
Yang Liu
Address 85784 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 85784 0
Australia
Phone 85784 0
+61 404669568
Fax 85784 0
Email 85784 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
According to the approved ethic application, all information is kept confidential. Only the main researchers and the supervisors can access the data documents. All data including the video recordings will be destroyed at the end of the 7-year retention period. The consent form that the participants signed does not mention that the data will be shared in the future.


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.