Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000210370
Ethics application status
Approved
Date submitted
14/11/2016
Date registered
8/02/2017
Date last updated
8/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of Te Whanau Pou Toru: Maori Adaptation of Primary Care Triple P Discussion Groups for Maori parents of young children with behavioural difficulties.
Scientific title
A randomised controlled trial of an adaptation of Triple P Positive Parenting Program Discussion Groups for Maori parents of young children with behavioural difficulties.
Secondary ID [1] 287643 0
Ministry of Health, 414953/349190/00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behaviour 296470 0
Parenting practices 296471 0
Condition category
Condition code
Public Health 296727 296727 0 0
Health promotion/education
Mental Health 300018 300018 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Triple P Discussion Groups are preventively focused interventions designed to provide specific advice about common child behaviour or developmental issues. During the two-hour group sessions, parents are taught about the principles of positive parenting, strategies for developing a good parent-child relationship, and strategies for managing specific problem behaviours. These strategies are alternatives to coercive and ineffective discipline strategies. All discussion groups involve video-modelling of behaviour management strategies, a tailored implementation plan, and training in planned activities routines to cope with high-risk situations. The format of the group session includes some didactic presentations, active skills training, and group discussions. Each discussion group is accompanied by a workbook.
The Triple P Discussion Groups used in this study will focus on two different topic areas: Being a Positive Parent and Dealing with Disobedience. During the Being a Positive Parent group parents are introduced to the principles of positive parenting and taught a range of skills aimed at assist them to support their child’s competence and development and to build a positive relationship with their child. The Dealing with Disobedience Triple P Discussion Group focuses on reasons for disobedience, parenting traps, ways to encourage positive child behaviour and strategies for dealing with disobedience.

The two face to face 2-hour discussion groups (one for each topic area) occurring one week apart, are delivered by accredited Maori Triple P practitioners. The discussion groups take place in health or community organisation meeting rooms.

Discussion groups are video-taped to monitor practitioner fidelity of programme implementation. Checklists created by the intervention developers are used to monitor intervention fidelity and provide a measure of the proportion of content covered in each group. Checklist ratings provide by the facilitator and an independent rater are compared to assess adherence to the intervention protocol.

Two adjunct resources were developed for this study. These were a graphic connecting eight tikanga (Maori values and ways of doing things) with the five Triple P positive parenting principles in the form of a Maori meeting house (Whare nui) image, and a worksheet which explained the eight tikanga and the Triple P principles and strategies. The resources were used within the parenting discussions groups to illustrate how the Triple P principles and the tikanga (values) of the local iwi (tribe) can both work together to build parenting skills. In addition, practitioners use culturally appropriate examples to illustrate within session exercises.

Condition 1
Participants allocated to the intervention group condition will participate in the discussion groups after completion of pre-intervention questionnaires and randomisation to group.

Condition 2
Participants allocated to the waitlist list condition will participate in the programme after both groups have completed follow-up questionnaires (6 months after the intervention group has participated in the discussion groups).
Intervention code [1] 293041 0
Behaviour
Intervention code [2] 295803 0
Prevention
Comparator / control treatment
The comparison group for the trial is the waitlist control group described above. The waitlist group will be offered the intervention after 6 months follow up is complete.
Control group
Active

Outcomes
Primary outcome [1] 296344 0
Change in child behaviour problems as measured by the two scales of the Eyberg Child Behaviour Inventory (ECBI) parent report questionnaire.
Timepoint [1] 296344 0
Pre-intervention (2-weeks before the intervention), post-intervention (five weeks after the intervention group had participated in the programme), and 6-month follow-up (6-months post-intervention)
Secondary outcome [1] 318220 0
Change in dysfunctional parenting practices as measured by the three subscales of the Parenting Scale (PS) self-report questionnaire.
Timepoint [1] 318220 0
Pre-intervention (2-weeks before the intervention), post-intervention (five weeks after the intervention group had participated in the programme), and 6-month follow-up (6-months post-intervention)
Secondary outcome [2] 329214 0
Changes in parenting self-efficacy as measured by the two sub scales of the Parenting Task Checklist (PTC) self report questionnaire.
Timepoint [2] 329214 0
Pre-intervention (2-weeks before the intervention), post-intervention (five weeks after the intervention group had participated in the programme), and 6-month follow-up (6-months post-intervention)

Eligibility
Key inclusion criteria
To participate in the study, parent participants will need to self-identify as:
1) Maori and
2) be concerned about the behaviour of their child who is aged between 3 and 7 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Parents of children with a developmental or intellectual disability (rationale: the Triple P Discussion Groups are designed for children with behavioural problems that are otherwise normally developing. A modified version of Triple P, Stepping Stones Triple P, has been specifically designed to meet the unique needs of parents who have children with a developmental, intellectual, or health disability).

2) The target child is currently having regular contact with another mental health professional for behavioural problems (rationale: if the target child is currently receiving support from another service, then it will be difficult to disentangle potential benefits gained from the provided programme from those gained by this external support).

3) The parent/s is currently seeing a mental health professional for emotional or psychological problems, or for their child's behavioural problems (rationale: if parents are receiving support from another service, then it will be difficult to disentangle potential benefits gained from the provided programme from those gained by this external support).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation. Allocation is stratified according to marital status (single/widow or married/defacto).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori power analyses based on estimates of effect sizes of similar Triple P brief parent discussion groups suggested that approximately 50 participants in total would be required to achieve power of .80.
An intent to treat approach will be used for all analyses.

To evaluate the short-term and long term effects of the intervention, differences between
the intervention and waitlist control groups will be examined using a series of two-group univariate and multivariate analyses of covariance (ANCOVAs and MANCOVAs) with T2 and T3 scores as dependent variables and T1 data as covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2015
Date of last participant enrolment
Anticipated
Actual
2/09/2016
Date of last data collection
Anticipated
Actual
17/11/2016
Sample size
Target
50
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 7220 0
New Zealand
State/province [1] 7220 0
Northland

Funding & Sponsors
Funding source category [1] 292471 0
Government body
Name [1] 292471 0
Ministry of Health
Country [1] 292471 0
New Zealand
Primary sponsor type
Individual
Name
Dr Louise Keown
Address
Parenting Research Group,
Faculty of Education
University of Auckland
74 Epsom Avenue
Epsom
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 291170 0
None
Name [1] 291170 0
N/A
Address [1] 291170 0
N/A
Country [1] 291170 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293679 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 293679 0
The University of Auckland,
Private Bag 92601,
Symonds St.,
Auckland 1150
Ethics committee country [1] 293679 0
New Zealand
Date submitted for ethics approval [1] 293679 0
03/02/2015
Approval date [1] 293679 0
31/03/2015
Ethics approval number [1] 293679 0
2015/013889

Summary
Brief summary
This study will evaluate the efficacy of a culturally adapted trial version of Primary Care Triple P for Maori families. Maori parents of a child between the ages of 3 and 7 who are concerned about their child’s behaviour, will be randomly assigned to either an intervention group or a waitlist group. The intervention will consist of two x 2-hour Triple P Parenting discussion groups: Being a Positive Parent and Dealing with Disobedience. Both groups will be assessed before and after the intervention group receives the Triple P intervention, and once again at 6-months post intervention. After the final assessment, the waitlist group will receive the intervention. It is predicted that compared to the waitlist group, parents receiving the Triple P intervention will report significant reductions at post intervention in child conduct problems. On secondary outcome variables, it is predicted that compared to parents in the waitlist group, parents in the Triple P intervention group will show significant reductions in ineffective parenting practices and will report greater confidence in managing their child’s behaviour.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 652 652 0 0
/AnzctrAttachments/369467-Outcome Approved.pdf

Contacts
Principal investigator
Name 60926 0
Dr Louise Keown
Address 60926 0
Faculty of Education,
University of Auckland
74 Epsom Avenue
Epsom
Auckland 1023
Country 60926 0
New Zealand
Phone 60926 0
+64 9 6238899 ext 86435
Fax 60926 0
Email 60926 0
l.keown@auckland.ac.nz
Contact person for public queries
Name 60927 0
Dr Louise Keown
Address 60927 0
Faculty of Education,
University of Auckland
74 Epsom Avenue
Epsom
Auckland 1023
Country 60927 0
New Zealand
Phone 60927 0
+64 9 6238899 ext 86435
Fax 60927 0
Email 60927 0
l.keown@auckland.ac.nz
Contact person for scientific queries
Name 60928 0
Dr Louise Keown
Address 60928 0
Faculty of Education,
University of Auckland
74 Epsom Avenue
Epsom
Auckland 1023
Country 60928 0
New Zealand
Phone 60928 0
+64 9 6238899 ext 86435
Fax 60928 0
Email 60928 0
l.keown@auckland.ac.nz

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
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Documents added automatically
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