Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000026426
Ethics application status
Approved
Date submitted
30/05/2006
Date registered
11/01/2007
Date last updated
10/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a couple-based program for promoting a positive transition to parenthood
Scientific title
A randomised controlled trial of the effects of Couple CARE (a couple-based program) for couples having their first child on couple relationship adjustment, individual partner mood and parenting competence.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Couple Relationship Distress and Divorce 1523 0
Individual Psychological Adjustment 1524 0
Parenting Stress 1525 0
Condition category
Condition code
Mental Health 1621 1621 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Couples are randomly allocated to either six 1-hour sessions (one per month until child is three months old) of a couple-focused psycho-education program entitiled 'Couple CARE for Parents'(CCP). Both programs are offered to couples expecting their first baby and continue until their first child is three months old.
Intervention code [1] 1073 0
Behaviour
Comparator / control treatment
Couples are randomly allocated to five 1-hour sessions (held monthly until child is three months old) of a mother-focused information and support program.
Control group
Active

Outcomes
Primary outcome [1] 2234 0
Couple relationship satisfaction (DAS). Couple seperation and divorce. Couple aggression (CTS2). Observed couple communication. Couple self-regulation (SRERS).
Timepoint [1] 2234 0
Follow-up assessments at 1 and 2 years post-partum.
Primary outcome [2] 2235 0
Couple seperation and divorce.
Timepoint [2] 2235 0
Follow-up assessments at 1 and 2 years post-partum.
Primary outcome [3] 2236 0
Couple aggression (CTS2).
Timepoint [3] 2236 0
Follow-up assessments at 1 and 2 years post-partum.
Primary outcome [4] 2237 0
Observed couple communication.
Timepoint [4] 2237 0
Follow-up assessments at 1 and 2 years post-partum.
Primary outcome [5] 2238 0
Couple self-regulation (SRERS).
Timepoint [5] 2238 0
Follow-up assessments at 1 and 2 years post-partum.
Secondary outcome [1] 3899 0
Individual psychological functioning (NCSDI; EPDS).
Timepoint [1] 3899 0
Follow-up assessments at 1 and 2 years post-partum.
Secondary outcome [2] 3900 0
Workplace performance (WPQ).
Timepoint [2] 3900 0
Follow-up assessments at 1 and 2 years post-partum.
Secondary outcome [3] 3901 0
Parenting Stress (PSI)
Timepoint [3] 3901 0
Follow-up assessments at 1 and 2 years post-partum.
Secondary outcome [4] 3902 0
Parenting satisfaction and competence (PSCS).
Timepoint [4] 3902 0
Follow-up assessments at 1 and 2 years post-partum.

Eligibility
Key inclusion criteria
Couples are eligible if they are a. married or in a cohabiting heterosexual relationship of duration 6 months or longer; b.have a Dyadic Adjustment Scale score of 90 or above indicting no severe relationship distress; c. expecting thier first live born child.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) neither partner reports severe physical aggression or frequent less severe physical aggression have occured in the last 12 months, (b) neither partner is currently receiving treatment for a psychological disorder or for a couple relationship problem.

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)
Random allocation occurs in a central office by research staff who are not involved in participant assessment or program delivery . Allocation is kept in a sealed envelope and concealed from couples, the researcher determing study eligibility, and midwife educators until all assessment information is returned and the couple meets eligibility criteria. After that point allocation concealement is no longer possible as one condition is a couple based education porgam and the other a woman only education condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A coin toss determines the allocation for a couple (heads = intervention), and the next couple who returns their assessment receives the opposite allocation. This ensures that equal numbers of couples are assignment to the intervention and control. The coin toss procedure is repeated until all couples are assigned.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1768 0
Government body
Name [1] 1768 0
NH&MRC
Country [1] 1768 0
Australia
Primary sponsor type
Individual
Name
Professor Kim Halford
Address
Mt Gravatt Campus School of Psychology
Griffith University
Country
Australia
Secondary sponsor category [1] 1573 0
Individual
Name [1] 1573 0
Professor Debra Creedy
Address [1] 1573 0
Gold Coast Campus Griffith University
Country [1] 1573 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3299 0
Griffih University
Ethics committee address [1] 3299 0
Ethics committee country [1] 3299 0
Australia
Date submitted for ethics approval [1] 3299 0
Approval date [1] 3299 0
01/01/2005
Ethics approval number [1] 3299 0
PSY/50/02
Ethics committee name [2] 3300 0
Royal Brisbane and Womens Hospital
Ethics committee address [2] 3300 0
Ethics committee country [2] 3300 0
Australia
Date submitted for ethics approval [2] 3300 0
Approval date [2] 3300 0
18/10/2002
Ethics approval number [2] 3300 0
RWH 02/10
Ethics committee name [3] 3301 0
Logan Hospital
Ethics committee address [3] 3301 0
Ethics committee country [3] 3301 0
Australia
Date submitted for ethics approval [3] 3301 0
Approval date [3] 3301 0
Ethics approval number [3] 3301 0
2005/068
Ethics committee name [4] 3302 0
Redlands Hospital
Ethics committee address [4] 3302 0
Ethics committee country [4] 3302 0
Australia
Date submitted for ethics approval [4] 3302 0
Approval date [4] 3302 0
18/08/2005
Ethics approval number [4] 3302 0
62-07-2005
Ethics committee name [5] 3303 0
Gold Coast Hospital
Ethics committee address [5] 3303 0
Ethics committee country [5] 3303 0
Australia
Date submitted for ethics approval [5] 3303 0
Approval date [5] 3303 0
31/08/2005
Ethics approval number [5] 3303 0
200539
Ethics committee name [6] 3304 0
Ipswich Hospital
Ethics committee address [6] 3304 0
Ethics committee country [6] 3304 0
Australia
Date submitted for ethics approval [6] 3304 0
Approval date [6] 3304 0
30/08/2005
Ethics approval number [6] 3304 0
6/05N

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

Contacts
Principal investigator
Name 36252 0
Address 36252 0
Country 36252 0
Phone 36252 0
Fax 36252 0
Email 36252 0
Contact person for public queries
Name 10262 0
Mrs Jemima Petch
Address 10262 0
School of Psychology
Griffith University
Mt Gravatt Campus
Level 4 Building M24
Mt. Gravatt QLD 4111
Country 10262 0
Australia
Phone 10262 0
+61 7 37353359
Fax 10262 0
Email 10262 0
[email protected]
Contact person for scientific queries
Name 1190 0
Professor Kim Halford
Address 1190 0
School of Psychology
Griffith University
Mt Gravatt Campus
Level 4 Building M24
Mt. Gravatt QLD 4111
Country 1190 0
Australia
Phone 1190 0
+61 7 37353311
Fax 1190 0
Email 1190 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
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