Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000155291
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
20/03/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of an intensive group parenting programme (Hoki ki te Rito/Mellow Parenting) for parents experiencing significant parenting problems
Scientific title
An evaluation of an intensive group parenting programme (Hoki ki te Rito/Mellow Parenting) for parents experiencing significant parenting problems on the effects of parental mental health
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mothers/caregivers experiencing significant parenting problems 4246 0
Condition category
Condition code
Mental Health 4537 4537 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mellow Parenting (MP) programme was developed specifically for families with a pre-school child where there were relationship problems or where there were other significant problems such as maternal depression or child protection issues. There is a strong emphasis on parental engagement and empowerment, individual analysis of video tape of a family interaction (e.g. at a mealtime), activities to practice new skills, structured parenting workshop, ‘homework’ to reinforce new skills etc. The programme is designed to improve mother-child interaction, child behaviour problems, mother’s wellbeing, mother’s effectiveness and confidence in parenting, and well as child behaviour and development.

Mellow Parenting is a 14 week programme (1 day, 5 hours a week).
Intervention code [1] 4034 0
Other interventions
Comparator / control treatment
stepped wedge design within subject wait list compared with intervention.Stepped wedge randomised trial designs involve sequential roll-out of an intervention to participants over different time periods. In this case people will apply to take part in the trial and the time to the start of the intervention can be considered random. The demand for the intervention exceeds places in the groups and there has been a waiting list for the intervention since the first pilot group was run in 2008. After recruitment and consent processes are completed, data will be collected monthly while participants are waiting and the change in outcomes over the waiting time will be compared with the change after receiving the intervention in each participant. This design is relevant for this situation as we predict (from our pilot) that the intervention will do more good than harm and lack of intervention is likely to result in poorer outcome for the parents and their pre-schoolers.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5415 0
The primary outcome measure is the mental health of the study parents after completion of the programme compared with their mental health while on the waiting list for the programme, as measured by the General Health Questionnaire (GHQ-30).
Timepoint [1] 5415 0
At baseline, monthly while waiting for programme to start, start of programme, completion of the programme, 3 months after completion
Secondary outcome [1] 9108 0
Secondary outcome measures assess child development and behaviour, and parental stress at completion of the programme compared with assessments on the waiting list. The scales evaluating these outcomes include:
Parenting Daily Hassles (PDH),
Interaction between the parent and child (using videoed interactions), Ages and Stages Questionnaire (Socio-Emotional Screener), Strengths and Difficulties Questionnaire (SDQ), participant's satisfaction with the parenting programme and appropriateness for Maori participant will be tested using Hua Oranga (Maori measure of satisfaction with health services).
Timepoint [1] 9108 0
At baseline, monthly while waiting for programme to start, start of programme, completion of the programme, 3 months after completion

Eligibility
Key inclusion criteria
Participants must:
1. Be a primary caregiver of at least one child less than five years of age on the day of consent
2. Female
3. Self-referring/seeking parenting support for difficulties with child-rearing
4. Be aged at least 16 years on day of consent
5. Have the child/ren predominantly living with them
6. Be living in the Counties Manukau DHB area at the first time of contact
7. Be able to provide written informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Parenting problems stemming from own or child’s disability/illness
2.Current acute psychiatric illness or above a threshold on General Health Questionnaire-30 (GHQ-30)
3.Current severe problems with alcohol/substance abuse (e.g. currently in detox)
4.Intellectual handicap

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 1551 0
New Zealand
State/province [1] 1551 0
Auckland

Funding & Sponsors
Funding source category [1] 4438 0
Government body
Name [1] 4438 0
Counties of Manukau DHB
Country [1] 4438 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Level 12, Auckland City Hospital Support Building, Park Road, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 3999 0
None
Name [1] 3999 0
Address [1] 3999 0
Country [1] 3999 0
Other collaborator category [1] 546 0
Other Collaborative groups
Name [1] 546 0
Ohomairangi Trust
Address [1] 546 0
95 Wiri Station Road, Manukau, Auckland 2104
Country [1] 546 0
New Zealand
Other collaborator category [2] 547 0
Other Collaborative groups
Name [2] 547 0
Anglican Trust for Women and Children
Address [2] 547 0
10 Beatty Street Otahuhu Auckland 1062
Country [2] 547 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6492 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6492 0
Ethics committee country [1] 6492 0
New Zealand
Date submitted for ethics approval [1] 6492 0
08/11/2008
Approval date [1] 6492 0
03/12/2008
Ethics approval number [1] 6492 0
NTX/08/11/108

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

Contacts
Principal investigator
Name 29227 0
Address 29227 0
Country 29227 0
Phone 29227 0
Fax 29227 0
Email 29227 0
Contact person for public queries
Name 12474 0
Karolina Stasiak
Address 12474 0
Auckland
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Country 12474 0
New Zealand
Phone 12474 0
(+649) 3737599 ext 83890
Fax 12474 0
(+649) 3737013
Email 12474 0
[email protected]
Contact person for scientific queries
Name 3402 0
Sally Merry
Address 3402 0
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Country 3402 0
New Zealand
Phone 3402 0
64 923 6981
Fax 3402 0
64 9 373 7013
Email 3402 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.