Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000176965
Ethics application status
Approved
Date submitted
30/01/2020
Date registered
17/02/2020
Date last updated
21/12/2021
Date data sharing statement initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of brief behavioral parent training for reducing disruptive behaviors in preschool children in Vietnam
Scientific title
A randomized controlled trial of brief behavioral parent training for reducing disruptive behaviors in preschool children in Vietnam compared to usual care
Secondary ID [1] 300292 0
None
Universal Trial Number (UTN)
Trial acronym
BBPTViet (Brief Behavior Parent Training - Vietnam)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disruptive behavior disorders/problem in preschool children 315882 0
Condition category
Condition code
Mental Health 314158 314158 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- BBPTViet includes a one-off training course that provides behavioral modification skills to parents of preschool children with disruptive behaviors and up to 4 times of follow-up support via telephone, email, Facebook messenger in 8 following weeks at the discretion of the participant.
- The course focuses on analytical skills to understand the meaning of behavior and parenting practices to increase desirable and reduce undesirable behaviors of the child. The skills involve (i) to analyze the relationship between the behavior and its antecedent and consequence, (ii) to identify the function of behavior, and (iii) to select appropriate solutions. The practices include special time, descriptive praise, tangible reward, physical affection, problem-solving, effective command, ignore, and time-out.
- The course consists of four dyadic 50-minute sessions and is organized on 2 consecutive Saturdays. The first 2 sessions will focus on theory training with active learning skills, including didactic teaching, interactive lecturing, role play, brainstorming. The last 2 sessions will be the time for discussing, brainstorming, rehearsal, and giving feedback. The participants will practice the trained skills and strategies with their child as their homework during the break time after the first 2 sessions. Therefore, the first 2 sessions are undertaken on one Saturday, and the remaining 2 sessions are completed on the following Saturday. The course contains no more than 25 parents who will group-discuss, brainstorm, and practice under the instruction of facilitators. The main facilitator who delivers the course and provides follow-up support is a clinical psychologist or a health professional with at least 3 years' experience in the child behavior field.
- Material includes a training manual that is specifically designed for this study, a manual-based PowerPoint presentation, and a fidelity checklist. The facilitator must use the presentation to train the parents and self-rate with the checklist to adhere to the intervention.
- There are 2 methods of delivery: (i) The primary investigator will online train local staff in Vietnam on how to implement the trial at the clinic. He will assist the local staff during the implementation of the trial. Participants will come to the hospital for assessment and intervention. (ii) The primary investigator will implement BBPTViet course via Zoom platform for parents/caregivers. All assessment and intervention will be conducted online.
Intervention code [1] 316566 0
Treatment: Other
Intervention code [2] 316568 0
Behaviour
Comparator / control treatment
- Control treatment is the current approach of the department (standard care). The parent will be individually counselled basic practices to reduce the current problem behaviors of the child. A leaflet of the counselling information that is specifically designed for this study will be provided to participant.
- Participants who follow the offline delivery will be counselled and receive the printout leaflet at the clinic. Those who are in online delivery will be counselled via Zoom platform and receive the leaflet via email.
Control group
Active

Outcomes
Primary outcome [1] 322558 0
The mean score of the Eyberg Child Behavior Inventory (ECBI) for measuring the severity of child disruptive behaviors (DB).
Timepoint [1] 322558 0
Baseline, 1, 2 (primary time-point), and 6 months after the completion of the training course
Primary outcome [2] 322559 0
The mean score of the Alabama Parenting Questionnaire revised for preschoolers (APQ-PC) for measuring parenting practices. The questionnaire is specifically revised from the APQ for this study.
Timepoint [2] 322559 0
Baseline, 1, 2 (primary time-point), and 6 months after the completion of the training course
Primary outcome [3] 322560 0
The number of child DB that are coded based on the Parent-Child Interaction Observation System (PIOS). The system is specifically designed for this study.
Timepoint [3] 322560 0
Baseline, 2 (primary time-point), and 6 months after the completion of the training course
Secondary outcome [1] 378942 0
The number of positive parenting practices that are coded based on the Parent-Child Interaction Observation System (PIOS). This outcome is primary.
Timepoint [1] 378942 0
Baseline, 2 (primary time-point), and 6 months after the completion of the training course
Secondary outcome [2] 378943 0
The number of negative parenting practices that are coded based on the Parent-Child Interaction Observation System (PIOS). This outcome is primary.
Timepoint [2] 378943 0
Baseline, 2 (primary time-point), and 6 months after the completion of the training course
Secondary outcome [3] 378944 0
The mean score of the Parent-Child Coercion Scale (PCCS) for evaluating how much coercion of a parent-child relationship based on the parent’s perception. This outcome is primary.
Timepoint [3] 378944 0
Baseline, 1, 2 (primary time-point), and 6 months after the completion of the training course
Secondary outcome [4] 378945 0
The mean score of the Parent Problems Checklist (PPC) for evaluating marital conflicts.
Timepoint [4] 378945 0
Baseline, 1, 2, and 6 months after the completion of the training course
Secondary outcome [5] 379773 0
The mean score of the Parenting Sense of Competence Scale (PSOC) for measuring parental confidence in parenting.
Timepoint [5] 379773 0
Baseline, 1, 2, and 6 months after the completion of the training course
Secondary outcome [6] 379774 0
The mean score of Depression Anxiety Stress Scale 21 (DASS 21) for assessing parent mental health conditions.
Timepoint [6] 379774 0
Baseline, 1, 2, and 6 months after the completion of the training course
Secondary outcome [7] 404491 0
The mean score of the Child Rearing Practices Questionnaire (CRPQ) for evaluating parenting skills.
Timepoint [7] 404491 0
Baseline, 1, 2 (primary time-point), and 6 months after the completion of the training course.

Eligibility
Key inclusion criteria
Any parent who is worrying about the disruptive behavior(s) of their 3 to 6-year-old child. A parent is eligible if the target child often displays at least 1 of the 12 common disruptive behaviors in the list that was created by the combination of conduct problem items of Strength and Difficulties Questionnaire (SDQ) and externalizing behaviors of Pediatric Symptom Checklist – 17 (PSC – 17).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. The child has sensory/ motor/ language impairment OR autism spectrum disorders, intellectual disability, anxiety disorder, depression disorder OR does not live with parents.
2. The parent is receiving any mental intervention support OR suffering mental health problem that is rated Moderate in any sub-scale of Depression Anxiety Stress Scale 21 (DASS 21)

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)
- For the offline delivery method: the randomization will be generated at the beginning of the assessment day before the interventions. Sealed opaque envelopes that contain either the BBPTViet or CAU will be arranged in a sequence based on the result of the randomization in a container. The container then is brought to and kept by the secretaries. The doctors who examine the parent-child dyad will not involve in the concealment procedure.
- For the online delivery method: the randomization will be conducted before the assessment 1 (baseline) happens. Participants who complete the assessment 1 will be allocated into intervention groups according to the randomization's result.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will assign participants to either the control or intervention group according to block randomization generated by the computer software WINPEPI (PEPI-for-Windows) to achieve the balance of 1:1 allocation. The block size is 6 but it will not be disclosed to ensure concealment.
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
We will use SPSS version 22 and R to conduct analyses based on intention-to-treat (ITT) principles. For all tests, we will use 2-sided p-values with alpha = < 0.05 level of significance. P-values will be reported to three decimal places. Hereafter is the statistical analysis plan:
- We use descriptive statistics to present the participant’s characteristics and outcomes (mean, standard deviation, frequency). Then, we will test the equivalence between 2 intervention arms at pre-intervention. Appropriate statistical analysis will be used to control the differences between two arms if they are available.
- We use General linear model to test the association of independent variables, such as intervention type, parent’s age group, parent’s education level, address, child’s gender, assessment time with the outcomes.
- To assess the impact of the training program on child behavior, we analyze the reliable improvement/deterioration and reliable recovery. The former counts the number of children having statistical differences in score of ECBI pre- and post-intervention. The latter informs the number of children having statistical differences in score of ECBI pre- and post-intervention AND the scores move below the clinical cut-off. We also categorize participants based on the clinical cut-off score of the ECBI at baseline then compare the outcomes between and among those categories at post-intervention. Finally, we calculate the number needed to treat (NNT) to identify how many parents needed to be trained to have one child's improvement and/or recovery.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/06/2020
Actual
15/12/2020
Date of last participant enrolment
Anticipated
3/07/2020
Actual
5/08/2021
Date of last data collection
Anticipated
20/02/2022
Actual
Sample size
Target
100
Accrual to date
Final
112
Recruitment outside Australia
Country [1] 22241 0
Viet Nam
State/province [1] 22241 0
All cities and provinces in Vietnam

Funding & Sponsors
Funding source category [1] 304716 0
University
Name [1] 304716 0
The Australian National University
Country [1] 304716 0
Australia
Funding source category [2] 304729 0
Charities/Societies/Foundations
Name [2] 304729 0
The Australian Psychological Society
Country [2] 304729 0
Australia
Primary sponsor type
University
Name
Research School of Psychology - Australian National University
Address
Building 39, The Australian National University, Science Rd,, Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 305030 0
Charities/Societies/Foundations
Name [1] 305030 0
The Australian Psychological Society
Address [1] 305030 0
257 Collins St, Melbourne VIC 3000
Country [1] 305030 0
Australia
Other collaborator category [1] 281141 0
Hospital
Name [1] 281141 0
Children's Hospital 1 (Benh vien Nhi dong 1)
Address [1] 281141 0
341 Su Van Hanh street, District 10, Ho Chi Minh City
Country [1] 281141 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305140 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 305140 0
Ethics committee country [1] 305140 0
Australia
Date submitted for ethics approval [1] 305140 0
14/01/2020
Approval date [1] 305140 0
20/11/2020
Ethics approval number [1] 305140 0
2019/965
Ethics committee name [2] 305155 0
Children's Hospital 1 Institutional Review Board
Ethics committee address [2] 305155 0
Ethics committee country [2] 305155 0
Viet Nam
Date submitted for ethics approval [2] 305155 0
05/06/2019
Approval date [2] 305155 0
26/03/2021
Ethics approval number [2] 305155 0
CS/N1/19/58

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

Contacts
Principal investigator
Name 99378 0
Dr Triet Pham
Address 99378 0
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 99378 0
Australia
Phone 99378 0
+61 0415056599
Fax 99378 0
Email 99378 0
[email protected]
Contact person for public queries
Name 99379 0
Triet Pham
Address 99379 0
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 99379 0
Australia
Phone 99379 0
+61 0415056599
Fax 99379 0
Email 99379 0
[email protected]
Contact person for scientific queries
Name 99380 0
Triet Pham
Address 99380 0
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 99380 0
Australia
Phone 99380 0
+61 0415056599
Fax 99380 0
Email 99380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator via email: [email protected] or [email protected]


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.