Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000076370
Ethics application status
Approved
Date submitted
7/02/2008
Date registered
11/02/2008
Date last updated
6/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a parenting support programme.
Scientific title
Two-stage pilot evaluation of an intensive group parenting programme (Hoki ki te Rito) for parents experiencing significant parenting problems
Secondary ID [1] 281500 0
Evaluation of a parenting programme
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting skills 2796 0
Condition category
Condition code
Mental Health 2931 2931 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a pilot evaluation of an intensive parenting programme delivered to Maori and Pacific parents. The programme (Hoki ki te Rito) is based on the methods from an established intervention called Mellow Parenting (MP) which is a 14 week programme (1 day, 5 hours a week) designed to support families with relationship problems with their infants and young children. It combines personal support for parents with a video and direct work with parents and children on their own parenting problems. Overseas, it has proved effective in recruiting and engaging families with a variety of severe problems. It aims to improve maternal well being, parent-child interaction, child behaviour and child development. The programme has been developed by a team led by Christine Puckering in UK.
Intervention code [1] 2536 0
Behaviour
Comparator / control treatment
We intend to run a two-stage evaluation. In the first phase, we will run a small open trial with up to 10 families. Formative feedback from this stage will be used to refine the programme and the delivery methods for phase 2. In the second phase, we will compare the programme against treatment as usual (a parenting course Whakatokia te Rongomau) with up to 20 families (10 per arm).Whakatokia te Rongomau is a routine care treatment provided by Ohomairangi for parents/whanau with parenting difficulties. This programme is has eight weekly session lasting two hours long. This programme has been developed in the mid 1990s and it consists of eight weekly sessions each lasting approximately two hours. It is a broad intervention and it has a focus on reducing family violence.
Control group
Active

Outcomes
Primary outcome [1] 3813 0
The primary outcome measure will be an assessment of a videoed interaction between the parent and child.
Timepoint [1] 3813 0
Immediately before intervention, post-intervention and eight week follow-up.
Secondary outcome [1] 6430 0
Secondary outcome measures will be standardised measures of child development & behaviour, parental health and wellbeing and a Maori-specific health measure: Ages and Stages Questionnaire (Socio-Emotional Screener); Strengths and Difficulties Questionnaire (SDQ); General Health Questionnaire-30 (GHQ-30); Parenting Daily Hassles; Hua Oranga
Timepoint [1] 6430 0
Immediately before intervention, post-intervention and eight week follow-up.

Eligibility
Key inclusion criteria
• Primary caregiver of a child less or equal four years of age
• Primary caregiver is a female
• Identifies as Maori
• Self-referring/seeking parenting support for difficulties with child-rearing
• Aged 16 years or more
• The child predominantly living with the primary caregiver
• Living in the Counties Manukau DHB area at the first time of contact
• Able to provide informed consent
Minimum age
16 Years
Maximum age
N/A
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Parenting problems stemming from own or child’s disability/illness
• Current acute psychiatric illness or above a threshold on General Health Questionnaire-30 (HGQ-30)
• Current severe problems alcohol/substance abuse (e.g. currently in detox)
• Intellectual handicap

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)
The first phase of this project will be an open trial. Sealed opaque envelopes will be used in the second phase of the pilot evaluation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a sequence generated by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 781 0
New Zealand
State/province [1] 781 0

Funding & Sponsors
Funding source category [1] 3057 0
Government body
Name [1] 3057 0
Dr Sally Merry
Country [1] 3057 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Country
New Zealand
Secondary sponsor category [1] 2755 0
Government body
Name [1] 2755 0
Counties Manukau District Health Board
Address [1] 2755 0
Private Bag 94052
South Auckland Mail Centre
Country [1] 2755 0
New Zealand
Other collaborator category [1] 200 0
Other Collaborative groups
Name [1] 200 0
Ohomairangi Trust
Address [1] 200 0
PO Box 23185
Hunters Corner
Auckland
Country [1] 200 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5009 0
Northern X Ethics Committee
Ethics committee address [1] 5009 0
Ethics committee country [1] 5009 0
New Zealand
Date submitted for ethics approval [1] 5009 0
Approval date [1] 5009 0
Ethics approval number [1] 5009 0
NTX/07/12/135

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

Contacts
Principal investigator
Name 28354 0
Address 28354 0
Country 28354 0
Phone 28354 0
Fax 28354 0
Email 28354 0
Contact person for public queries
Name 11511 0
Dr Sally Merry
Address 11511 0
Werry Centre for Child and Adolescent Mental Health
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Country 11511 0
New Zealand
Phone 11511 0
006493737599 ext 86981
Fax 11511 0
006493737013
Email 11511 0
[email protected]
Contact person for scientific queries
Name 2439 0
Dr Sally Merry
Address 2439 0
Werry Centre for Child and Adolescent Mental Health
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Country 2439 0
New Zealand
Phone 2439 0
006493737599 ext 86981
Fax 2439 0
006493737013
Email 2439 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.