Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000317594
Ethics application status
Approved
Date submitted
20/07/2006
Date registered
24/07/2006
Date last updated
24/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised study to evaluate the efficacy of a parenting intervention, Family Transitions Triple P, to to prevent negative outcomes for children following divorce
Scientific title
A randomised study to evaluate the efficacy of a parenting intervention, Family Transitions Triple P, to to prevent negative outcomes for children following divorce
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children following divorce 1288 0
Condition category
Condition code
Other 1378 1378 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family Transitions Triple P - 10, 2 hourly group session parenting intervention designed to address the key risk factors for negative outcomes for children following parental divorce. Participants will be randomly assigned to one of two treatment conditions (enhanced or standard) or a waitlist control group. The standard group will receive the 10 week group program. The enhanced condition will receive a brief weekly telephone call to encourage group attendance, in addition to the standard program. Program facilitators will be blinded to group membership.
Intervention code [1] 798 0
Behaviour
Comparator / control treatment
The waitlist control group will receive the intervention approximately 14 weeks later.
Control group
Active

Outcomes
Primary outcome [1] 1879 0
To evaluate the effectiveness of Family Transitions Triple P, parents will complete self-report measures of both parent and child functioning (Parenting practices, social support, stress, co-parental relationship with ex-partner). Teachers will complete self-report measures of child functioning at school.
Timepoint [1] 1879 0
Assessment will take place at pre- and post intervention and 12 month follow-up.
Secondary outcome [1] 3322 0
None
Timepoint [1] 3322 0

Eligibility
Key inclusion criteria
Parent has been separated or divorced < 24 months. There is no gender restriction on participation.Child must be aged between 2 - 14 years.Parent is experiencing with significant problems with either co-parental conflict; parenting and child behaviour; or coping.
Minimum age
2 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parent does not have reading English competency.

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)
Central randomisation by independent researcher who will be contacted in person or via phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomization list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1510 0
Government body
Name [1] 1510 0
Australian Research Council
Country [1] 1510 0
Australia
Primary sponsor type
University
Name
The University of Queensland-
Address
Country
Australia
Secondary sponsor category [1] 1327 0
Charities/Societies/Foundations
Name [1] 1327 0
Relationships Australia
Address [1] 1327 0
Country [1] 1327 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2935 0
The School of Psychology Ethics Committee The University of Queensland
Ethics committee address [1] 2935 0
Ethics committee country [1] 2935 0
Australia
Date submitted for ethics approval [1] 2935 0
Approval date [1] 2935 0
13/03/2006
Ethics approval number [1] 2935 0
06-PSYCH-PhD-02-JM 1

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

Contacts
Principal investigator
Name 35416 0
Address 35416 0
Country 35416 0
Phone 35416 0
Fax 35416 0
Email 35416 0
Contact person for public queries
Name 9987 0
Dr Helen Stallman
Address 9987 0
Parenting and Family Support Centre School of Psychology The University of Queensland St Lucia QLD 4072
Country 9987 0
Australia
Phone 9987 0
07 3365 7304
Fax 9987 0
Email 9987 0
[email protected]
Contact person for scientific queries
Name 915 0
Dr Helen Stallman
Address 915 0
Parenting and Family Support Centre School of Psychology The University of Queensland St Lucia QLD 4072
Country 915 0
Australia
Phone 915 0
07 3365 7304
Fax 915 0
Email 915 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.