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Trial registered on ANZCTR


Registration number
ACTRN12616000860460
Ethics application status
Approved
Date submitted
28/06/2016
Date registered
30/06/2016
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Date results information initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the Triple P Parenting Intervention for Migrant and Former-Refugee Parents: Randomized Controlled Trial
Scientific title
Examining the efficacy of a brief, evidence-based parenting intervention aimed at improving family adjustment during settlement in Australia: Randomized controlled trial comparing the Triple P Disobedience Discussion Group program against wait-list control with migrant and former-refugee parents from culturally and linguistically diverse (CALD) backgrounds.
Secondary ID [1] 289561 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological wellbeing 299285 0
parenting practices and behaviour 299286 0
sociocultural adaptation and acculturative stress 299287 0
child emotional and behavioural problems 299288 0
parenting confidence 299289 0
Condition category
Condition code
Mental Health 299283 299283 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 299284 299284 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention involves parental attendance at a brief, group-based parenting program: Triple P Disobedience Discussion Group. A group-based program is cost-effective and can offer a favourable environment in which participants can build connections through interacting with others with shared experiences. The intervention itself will involve parental attendance at a single three-hour discussion group focused on preventing and managing child misbehaviour, and encouraging positive behaviours. Parents may attend individually or with their partner, however data will be collected from a single caregiver only. The program draws on social learning theory and through utilizing the key principals of the Triple P System, encourages an interactive environment that facilitates open discussion between participants. Up to five groups (with identical content) will be held with approximately 10 participants in each. Two weeks following the intervention, a group-based two-hour consultation session will be offered to participants to assist with strategy implementation and discuss concerns and/or questions that may arise following the program.

Parents will receive a workbook (that is theirs to keep), and a resource pack (including behaviour monitoring records and positive behaviour charts etc). During the intervention, parents will view powerpoint slides including short video segments. To ensure program fidelity it maintained, accredited program facilitators will follow a detailed presentation guide and will have the content of their sessions monitored using a program checklist. Participants in the intervention group will be known as the "Start Now" group.

Intervention code [1] 295157 0
Behaviour
Comparator / control treatment
The control group will be a wait-list control, known as the "Start Later" group. Parents in the Start Later group will be assessed at the same time points as the intervention group participants (i.e. baseline, 4 weeks following the final intervention group program, and 6 months later). Start Later group participants will be offered access to a suitable Triple P parenting program following collection of the final data point (i.e. 6 months following the final intervention group attends the program). Parents will continue to have access to all usual community-based family support services throughout the study.
Control group
Active

Outcomes
Primary outcome [1] 298774 0
Parenting Confidence - total score as measured by the CAPES Parent Efficacy Scale (Morawska et al., 2014).
Timepoint [1] 298774 0
Pre-intervention, 4-weeks post-intervention, 6-months post-intervention.
Primary outcome [2] 298775 0
Parental Psychological Well-being as measured by the DASS-21 (Lovibond & Lovibond, 1995): Total Depression, Anxiety, and Stress symptom scores.
Timepoint [2] 298775 0
Pre-intervention, 4-weeks post-intervention, 6-months post-intervention.
Primary outcome [3] 298776 0
Parental Acculturative Stress total score as measured by the Riverside Acculturative Stress Inventory (Miller, Kim, & Benet-Martinez, 2011).
Timepoint [3] 298776 0
Pre-intervention, 4-weeks post-intervention, 6-months post-intervention.
Secondary outcome [1] 325155 0
Parenting behaviour and practices as measured by the The Parenting Scale (Arnold, O’Leary, Wolff, & Acker, 1993) and The Corporal Punishment Questionnaire (adapted from UNICEF Division of Policy and Planning, Multiple Indicator Cluster Survey Manual, 2006).
Timepoint [1] 325155 0
Pre-intervention, 4-weeks post-intervention, 6-months post-intervention.
Secondary outcome [2] 325156 0
Child adjustment indicated by the frequency of parent reported emotional and behavioural problems as measured by CAPES- Child Adjustment Scale (Morawska et al., 2104).
Timepoint [2] 325156 0
Pre-intervention, 4-weeks post-intervention, 6-months post-intervention.
Secondary outcome [3] 325157 0
Parental sociocultural adjustment as measured by the Sociocultural Adaptation Scale (Ward & Kennedy, 1999).
Timepoint [3] 325157 0
Pre-intervention, 4-weeks post-intervention, 6-months post-intervention.
Secondary outcome [4] 325158 0
Program satisfaction: assessed using the Client Satisfaction Questionnaire (adapted) (Morawska & Sanders, 2010).
Timepoint [4] 325158 0
4-weeks post-intervention

Eligibility
Key inclusion criteria
Participant inclusion criteria will specify that participants: (i) are a parent of a 2-12 year old child, (ii) have lived in Australia no more than five years (iii) can read and understand basic English, and (iv) are over the age of 18 (the age of consent).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from participating if they (i) are known to be in the process of receiving treatment for a severe psychological illness, (ii) are unable to read or understand basic English (in order to understand program content), (iii) or do not possess a valid humanitarian or migrant visa.

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)
Opaque enveloped labelled with participant ID number and containing a randomization notification letter will be used to conceal group allocation. Allocation to groups will not be revealed until all participants have been recruited for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will occur using a computer based random number generator.

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Target sample size was determined using analysis software and a review of previous research, based on a desire to have power (.95) to detect a medium effect (d=.50), with an assumed alpha level of .05. An additional 20% was added to the resulting sample size to account for attrition, based on the percentage of participants lost at follow-up in the preceding pilot study. Mixed between-within ANOVAs and MANOVAs will be conducted to evaluate intervention effects following program completion, and at 6-months follow up. Pairwise comparisons will be used to examine significant differences in the dependent variables between conditions (i.e. intervention vs. waitlist control) and times (i.e. pre-intervention, post-intervention, 6-month follow up).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 293934 0
University
Name [1] 293934 0
The University of Queensland, Parenting and Family Support Centre
Address [1] 293934 0
Parenting and Family Support Centre
School of Psychology
Rm s327, Social Sciences Building (Blg 24),
The University of Queensland
ST LUCIA
QLD 4072
Country [1] 293934 0
Australia
Primary sponsor type
Individual
Name
Kathryn Esparza (nee Monty)
Address
Parenting and Family Support Centre
School of Psychology
Rm s327, Social Sciences Building (Blg 24),
The University of Queensland
ST LUCIA
QLD 4072
Country
Australia
Secondary sponsor category [1] 292759 0
Individual
Name [1] 292759 0
Divna Haslam
Address [1] 292759 0
Parenting and Family Support Centre
School of Psychology
Social Sciences Building (Blg 24)
The University of Queensland
St Lucia
QLD 4072
Country [1] 292759 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295349 0
UQ Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 295349 0
UQ Research & Innovation
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia
QLD 4072
Ethics committee country [1] 295349 0
Australia
Date submitted for ethics approval [1] 295349 0
31/03/2016
Approval date [1] 295349 0
19/05/2016
Ethics approval number [1] 295349 0
2016000274

Summary
Brief summary
This study will answer the research question of whether receiving contextually and culturally appropriate parenting support early in the settlement period can improve adjustment in migrant and former-refuge families, and by extension, facilitate positive sociocultural adaptation. The aims of the project are to: (a) Determine whether parental participation in a Triple P intervention within the first five years of settlement is effective at improving migrant and former-refugee family outcomes, and (b) Evaluate the efficacy of the program for improving sociocultural adjustment and reducing acculturative stress in migrant parents. The rigorous methodology being utilised in the current study will provide a strong indication as to the generalizability of the results to migrant and former-refugee families in other geographic regions. Should the intervention prove to be effective, it has the potential to fill an important research and service gap, providing an innovative, cost-effective, and evidence-based means to strengthen family relationships and promote positive adjustment in migrant children and their parents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66982 0
Ms Kathryn Monty
Address 66982 0
Parenting and Family Support Centre School of Psychology Rm s327, Social Sciences Building (Blg 24), The University of Queensland
ST LUCIA QLD 4072
Country 66982 0
Australia
Phone 66982 0
+61 7 3365 8870
Fax 66982 0
Email 66982 0
k.monty@uq.edu.au
Contact person for public queries
Name 66983 0
Ms Kathryn Monty
Address 66983 0
Parenting and Family Support Centre School of Psychology Rm s327, Social Sciences Building (Blg 24), The University of Queensland
ST LUCIA QLD 4072
Country 66983 0
Australia
Phone 66983 0
+61 7 3365 8870
Fax 66983 0
Email 66983 0
k.monty@uq.edu.au
Contact person for scientific queries
Name 66984 0
Ms Kathryn Monty
Address 66984 0
Parenting and Family Support Centre School of Psychology Rm s327, Social Sciences Building (Blg 24), The University of Queensland
ST LUCIA QLD 4072
Country 66984 0
Australia
Phone 66984 0
+61 7 3365 8870
Fax 66984 0
Email 66984 0
k.monty@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidential data
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary