- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076229
Relationship Education:Project Harmony
June 29, 2021 updated by: University of Central Florida
A Randomized Control Trial of Relationship Education: Project Harmony
The purpose of this study is to evaluate the effectiveness of relationship education (RE) for individuals and couples participating in Project Harmony.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although considerable research supports the positive effects of relationship education (RE) on relationship satisfaction and communication skills, the majority of existing research designs have favored pre/post or quasi-experimental designs.
Furthermore, gaps in the empirical bases for RE remain regarding programmatic moderators that influence change.
Consequently, there has been less emphasis on understanding which program elements contribute to positive change within couple relationships.
To this end, Project Harmony seeks to conduct an impact local evaluation design utilizing a randomized control trial (RCT) to assess the effectiveness of relationship education between low income, ethnically diverse individuals and couples in the treatment group compared to the wait-list control group.
Secondary research questions are focused on investigating mechanisms and moderators of change for the target population.
Participants (individuals and couples) in Project Harmony will be randomly assigned to either the treatment or wait-list control group.
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32816
- University of Central Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals and couples who are at least 18 years of age.
Exclusion Criteria:
- Does not meet the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Marriage: Treatment
Intervention: Behavioral: Healthy Marriage Program
|
Provide the following allowable activities 1) marriage and relationship education/skills, 2) relationship enhancement, 3) premarital education, and 4) divorce reduction.
|
Experimental: Healthy Marriage: Wait-list Control
Intervention: Behavioral: Healthy Marriage Program
|
Provide the following allowable activities 1) marriage and relationship education/skills, 2) relationship enhancement, 3) premarital education, and 4) divorce reduction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1200 participants with relational and interpersonal stressors
Time Frame: 6 months
|
The primary research question for the proposed investigation is: What are the effects of relationship education on relationship satisfaction (as measured by the Dyadic Adjustment Scale); between participants who received the intervention (treatment group) as compared with participants who did not immediately receive the intervention (wait-list control group)?
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1200 participants with relational and interpersonal stressors
Time Frame: 6 months
|
What are the effects of relationship education on dyadic coping (as measured by the Dyadic Coping Inventory); between participants who received the intervention (treatment group) as compared with participants who did not immediately receive the intervention (wait-list control group)?
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1200 participants with relational and interpersonal stressors
Time Frame: 6 months
|
What are the effects of relationship education on communication (as measured by Communication Patterns Questionnaire-Short Form); between participants who received the intervention (treatment group) as compared with participants who did not immediately receive the intervention (wait-list control group)?
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sejal M Barden, PhD, University of Central Florida
- Study Director: Bridgette Toussaint, MS, University of Central Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
September 29, 2020
Study Completion (Actual)
September 29, 2020
Study Registration Dates
First Submitted
February 8, 2017
First Submitted That Met QC Criteria
March 6, 2017
First Posted (Actual)
March 10, 2017
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- UCF MFRI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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