- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790761
Guam Healthy Relationships Education Program (GHREP)
May 28, 2020 updated by: WestCare Pacific Islands, Inc.
The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program that will foster healthy relationships and marriages on the island of Guam.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed Guam Healthy Relationships Education Program will improve the quality of life for individuals/couples in Guam by using culturally responsive approaches to foster healthy relationships and marriages using an Observational approach as there will be no comparison group, only the control group.
Project activities include a 6-month education program of interactive curriculum-based groups and positive social/recreational activities to achieve positive outcomes for individuals/couples, community awareness events, and community and parenting skills training.
The services offered is entrenched in cultures and traditions that are meaningful to the people of Guam, and includes capacity building and community awareness activities that will change community, family, and peer normative environments and attitudes.
Study Type
Interventional
Enrollment (Actual)
556
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
-
-
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Hagatna, Guam, 96910
- WestCare Pacific Islands Reflection Center
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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 to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Currently in a long-term relationship, does not have to include marriage
- Must be at least 18 years old
- At least one of the partners need to be between the ages of 18-35 years old
Exclusion Criteria:
- Under the age of 18 years
- Not in a long-term relationship
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: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: PREP 8.0 Curriculum
All participants enrolled in the program will be given the PREP 8.0 curriculum - there will be no comparison group.
|
The PREP 8.0 curriculum is an experiential curriculum designed to be implemented in a workshop or educational setting.
Using techniques of cognitive-behavioral marital therapy and communication-oriented marital enhancement, PREP aims to help couples achieve high levels of relationship functioning and prevent marital problems.
The PREP approach is based on research in the field of relational and marital health and success conducted at the University of Denver.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Relationship Satisfaction
Time Frame: The pre-test is administered before starting the curriculum and the post-test is administered immediately following the conclusion of the curriculum.
|
The PREP 8.0 curriculum pre- and post-test will be administered to program participants to determine if there are any changes in relationship satisfaction.
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The pre-test is administered before starting the curriculum and the post-test is administered immediately following the conclusion of the curriculum.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Intimate Partner Violence
Time Frame: The screening is administered before starting the curriculum and the screening is administered again immediately following the conclusion of the curriculum.
|
The HITS Screening Assessment will be administered to program participants to determine if there are any changes in intimate partner violence as a result of participating in the PREP 8.0 curriculum.
|
The screening is administered before starting the curriculum and the screening is administered again immediately following the conclusion of the curriculum.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melissa Rhea, Ed.D., WestCare Foundation, Inc.
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)
March 31, 2020
Study Completion (ACTUAL)
March 31, 2020
Study Registration Dates
First Submitted
November 14, 2018
First Submitted That Met QC Criteria
December 28, 2018
First Posted (ACTUAL)
January 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 29, 2020
Last Update Submitted That Met QC Criteria
May 28, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 5589
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
WestCare is willing to work with other researchers in the field for the betterment of the quality of life of Guam's community.
An individual participant data (IPD) will be determined based upon potential partner.
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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