Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001209381
Ethics application status
Approved
Date submitted
27/07/2017
Date registered
18/08/2017
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of Group Triple P – Positive Parenting Program to enhance co-parenting practices among Vietnamese generations: Randomized Controlled Trial
Scientific title
Evaluation of the efficacy of Group Triple P – Positive Parenting Program to enhance co-parenting practice between parent and grandparent in Vietnam: Randomized Controlled Trial
Secondary ID [1] 292549 0
Nil known
Universal Trial Number (UTN)
U1111-1199-9081
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intergenerational conflict in parenting
 304204 0
Condition category
Condition code
Public Health 303542 303542 0 0
Other public health
Mental Health 303543 303543 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study focus on improving the coparenting experience between parent and grandparents in the Asian family context. The target of this intervention are Vietnamese parents who having some sort of conflict with the grandparents regarding grandchild care.

Group Triple P plus the Building Coparenting Alliance module has been chosen as the intervention to be used in this study. The entire program consists of nine sessions, of which, 5 sessions occur in the group context. These 5 sessions will be divided into 2 all-day training blocks; each block will be administered once per week for 2 weeks. The other four sessions occur through phone call consultations (15-30 mins each) in every 5 days post intervention. The 5 in-group sessions focused on providing parents skills and strategies needed to manage their children behaviors as well as skills and strategies to manage their relationship with the grandparents . The other four follow-up phone calls were designed to help families tailor the program to the family needs.

Parents will be provided with Group Triple P workbook and handouts, all in Vietnamese and the program will be delivered in Vietnamese by the principle researcher of this project who was trained and certified with Group Triple P and is fluently in Vietnamese language.

Parents in the intervention group will receive intervention in late 2017 (ideal October). Waitlist group will receive a Triple P intervention after the six-month follow up assessment.
Intervention code [1] 298746 0
Behaviour
Intervention code [2] 298756 0
Treatment: Other
Comparator / control treatment
Parents in the waitlist control group will be assessed at the same time as the intervention group but will receive a Triple P intervention after the study has been completed and all data has been collected (6 months after the intervention group).
Control group
Active

Outcomes
Primary outcome [1] 302911 0
Change in coparenting cooperation and conflict; which will be measured by the Coparenting Quality Scale
Timepoint [1] 302911 0
T1: Baseline
T2: post-intervention (immediately after the 6 weeks of intervention)
T3: Follow up (6 months from post-intervention)

Primary timepoint: T2
Secondary outcome [1] 337421 0
Change in parental adjustment (assessed by the Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [1] 337421 0
T1: Baseline
T2: post-intervention (immediately after the 6 weeks of intervention)
T3: Follow up (6 months from post-intervention)

Primary timepoint: T2
Secondary outcome [2] 337422 0
Program satisfaction as assessed by The Client Satisfaction Questionnaire (CSQ; Turner et al., 2002). This questionnaire was adapted to include open questions about cultural acceptability.
Timepoint [2] 337422 0
T2: post-intervention (immediately after the 6 weeks of intervention) only
Secondary outcome [3] 337441 0
Change in child behavior (measured by the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999).
Timepoint [3] 337441 0
T1: Baseline
T2: post-intervention (immediately after the 6 weeks of intervention)
T3: Follow up (6 months from post-intervention)

Primary timepoint: T2
Secondary outcome [4] 337442 0
Change in parent's parenting practice (measured by the Parenting Scale (PS; Arnold, O'Leary, Wolff, & Acker, 1993).
Timepoint [4] 337442 0
T1: Baseline
T2: post-intervention (immediately after the 6 weeks of intervention)
T3: Follow up (6 months from post-intervention)

Primary timepoint: T2

Eligibility
Key inclusion criteria
The participants will be Vietnamese parents
(1) whose children are between the age of 2-12
(2) are living with grandparents or having grandparents taking care of their children
(3) Having conflict with grandparents about raising the grandchildren
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- The child shows evidence of developmental disorders (e.g., autism) and/or chronic illness, including language and speech impairment;
- The child is currently having regular contact with another professional or agency or taking medication for behavioural problems;
- The parent is currently seeing a professional for parenting support, primarily relating to their child’s behaviour difficulties;
- The parent is receiving psychological/psychiatric help or counselling (personal/marital);
- The parent is intellectually and/or hearing impaired;
- The parent is not able to read/write Vietnamese without assistance.

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)
The participants will be mainly selected from the pool of 250 parents took part in the project’s survey in Feb-April 2017 who indicated that they would like to participate in this training program. Also, advertising will be posted on researcher’s facebook and her network in order to catch attention from other parents who had not had a chance to participate in our previous survey. Any new register is welcomed.
All of the parents will receive a screening survey from project to confirm their eligibility. Only parents that meet study requirements will be selected to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be implemented using a list of computer generated random numbers, and families will be assigned sequentially to condition according to the list using a series of pre-labelled, sealed opaque envelopes, administered by a research assistant, to ensure that the first researcher is blind to group assignment.
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
Data will be analysed using compare means method inluding t-test, ANOVA, MANOVA and SEM (if needed)
The sample size was determined using using G-Power with a desire to have a minimum of 80% power (Cohen, 1988).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2017
Actual
16/10/2017
Date of last participant enrolment
Anticipated
15/10/2017
Actual
16/12/2017
Date of last data collection
Anticipated
8/07/2018
Actual
18/07/2018
Sample size
Target
120
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 9110 0
Viet Nam
State/province [1] 9110 0
Ho Chi Minh City/Hanoi

Funding & Sponsors
Funding source category [1] 297125 0
University
Name [1] 297125 0
The University of Queensland
Country [1] 297125 0
Australia
Primary sponsor type
Individual
Name
April Hoang
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 296137 0
None
Name [1] 296137 0
Address [1] 296137 0
Country [1] 296137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298299 0
School of Psychology, Ethics Review Committee
Ethics committee address [1] 298299 0
Ethics committee country [1] 298299 0
Australia
Date submitted for ethics approval [1] 298299 0
22/06/2017
Approval date [1] 298299 0
03/07/2017
Ethics approval number [1] 298299 0
17-PSYCH-PHD-43-JS

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

Contacts
Principal investigator
Name 76634 0
Ms April Hoang
Address 76634 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 76634 0
Australia
Phone 76634 0
+61 415208534
Fax 76634 0
Email 76634 0
[email protected]
Contact person for public queries
Name 76635 0
April Hoang
Address 76635 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 76635 0
Australia
Phone 76635 0
+61 415208534
Fax 76635 0
Email 76635 0
[email protected]
Contact person for scientific queries
Name 76636 0
April Hoang
Address 76636 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 76636 0
Australia
Phone 76636 0
+61 415208534
Fax 76636 0
Email 76636 0
[email protected]

No information has been provided regarding IPD availability


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.