Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12612000167864
Ethics application status
Approved
Date submitted
6/02/2012
Date registered
6/02/2012
Date last updated
25/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Couple Relationship Education with Military Couples
Scientific title
Evaluating Couple Relationship Education with Australian Defence Force Personnel and their Partners; Effects of a Military-specific Intervention on Relationship Outcomes
Secondary ID [1] 279885 0
Nil
Universal Trial Number (UTN)
U1111-1127-9778
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relationship Distress 285785 0
Condition category
Condition code
Mental Health 285961 285961 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An existing skills-training Couple Relationship Education program, Couple CARE, will be tailored to address the needs of military couples.

This intervention is designed to prevent couples from experiencing relationship distress; military couples are likely at higher risk of distress than civilian couples, due to the unique demands placed on their relationship such as postings, separations and deployments.

The program will consist of 6-7 units, each addressing a different aspect of couple relationships (e.g. communication, conflict management), aimed at teaching couples the skills required to maintain a mutually-satisfying relationship. The program will take approximately 7 weeks in total to complete.

Couples will complete the intervention in flexible delivery format. Couples are sent materials and instructed to complete each unit at home in their own time. For each unit, couples watch a short vignette on a DVD and complete exercises in a guidebook; some activities are completed individually, and some as a couple. Each unit takes approximately 50 minutes to complete. Couples then have a 50 minute telephone or Skype session with their educator, who revises the content and helps the couple apply the ideas to their own relationship. While the program is designed to fit around the busy military lifestyle, ideally couples will complete one unit (total 100 minutes) per week for 6-7 weeks (program yet to be finalised).
Intervention code [1] 284204 0
Prevention
Intervention code [2] 284206 0
Behaviour
Intervention code [3] 284207 0
Lifestyle
Comparator / control treatment
As this study is a randomised controlled trial, half of the participants will be assigned to a control group. The control group will receive a standard relationship enhancement intervention in the form of a book. This control allows couples the chance to benefit from their participation, but lacks the skills-training component that is key in Couple Relationship Education.
Control group
Active

Outcomes
Primary outcome [1] 286452 0
Score on Couples Satisfaction Index R, assessing relationship satisfaction
Timepoint [1] 286452 0
Pre-trial, post-trial (7 weeks) and at 6-month follow-up
Primary outcome [2] 286453 0
Score on Relationship Status Inventory, assessing relationship stability
Timepoint [2] 286453 0
Pre-trial, post-trial (7 weeks) and at 6-month follow-up
Primary outcome [3] 286454 0
Level of couples' communication, assessed using a problem solving discussion task
Timepoint [3] 286454 0
Pre-trial, post-trial (7 weeks) and at 6-month follow-up
Secondary outcome [1] 295920 0
Score on Conflict Tactics Scale R, assessing Intimate Partner Violence
Timepoint [1] 295920 0
Pre-trial and at 6-month follow-up

Eligibility
Key inclusion criteria
At least one partner must be a currently-serving, full-time member of the Australian Defence Force; the couple will have been married, engaged or cohabiting for a period of six months or longer; both partners must have written and verbal fluency in English; both partners must reside in the Brisbane area, and each individual must consent to their participation in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Couples will be excluded if initial assessment data suggest the couple are experiencing high levels of relationship distress; if the couple is currently undergoing couple therapy, or if either partner is currently receiving individual treatment for a psychological or psychiatric condition.

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)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
14/03/2013
Date of last participant enrolment
Anticipated
Actual
23/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284652 0
University
Name [1] 284652 0
University of Queensland
Country [1] 284652 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 283560 0
None
Name [1] 283560 0
Address [1] 283560 0
Country [1] 283560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286647 0
Ethics committee address [1] 286647 0
Ethics committee country [1] 286647 0
Date submitted for ethics approval [1] 286647 0
25/02/2012
Approval date [1] 286647 0
30/08/2012
Ethics approval number [1] 286647 0

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

Contacts
Principal investigator
Name 33738 0
Prof W. Kim Halford
Address 33738 0
School of Psychology
The University of Queensland
St Lucia QLD 4067
Country 33738 0
Australia
Phone 33738 0
+61 7 3365 6375
Fax 33738 0
Email 33738 0
[email protected]
Contact person for public queries
Name 16985 0
Ms. Melissa Bakhurst
Address 16985 0
School of Psychology
University of Queensland
St Lucia QLD 4072
Country 16985 0
Australia
Phone 16985 0
+61 7 3346 9510
Fax 16985 0
Email 16985 0
[email protected]
Contact person for scientific queries
Name 7913 0
Prof. Kim Halford
Address 7913 0
School of Psychology
University of Queensland
St Lucia QLD 4072
Country 7913 0
Australia
Phone 7913 0
+61 7 3365 6375
Fax 7913 0
Email 7913 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.