Health BehaviorGHREPNCT03790761
Guam Healthy Relationships Education Program
A study testing PREP 8.0 Curriculum in people with Health Behavior, run by WestCare Pacific Islands, Inc. at 1 site in Guam.
Trial summary
The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program that will foster healthy relationships and marriages on the island of Guam. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- PREP 8.0 Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteGuam
- Study dates
- 1 Jul 2016to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Under the age of 18 years
- Not in a long-term relationship
Trial locations and contacts
1 site in 1 country.
About this study
The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program that will foster healthy relationships and marriages on the island of Guam.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- PREP 8.0 Curriculum
- Keywords
- Guam, healthy relationships, non-profit organization, PREP 8.0 curriculum
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREP 8.0 CurriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PREP 8.0 Curriculum | Experimental | All participants enrolled in the program will be given the PREP 8.0 curriculum - there will be no comparison group. Receives: Behavioral: PREP 8.0 Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Relationship Satisfaction
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.
Measured: The pre-test is administered before starting the curriculum and the post-test is administered immediately following the conclusion of the curriculum.
Secondary outcomes (1)
Change in Intimate Partner Violence
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.
Measured: The screening is administered before starting the curriculum and the screening is administered again immediately following the conclusion of the curriculum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Jul 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- WestCare Pacific Islands, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Responsible party
- Sponsor
- Investigators
- Melissa Rhea, Ed.D., Principal investigator, WestCare Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790761
- Sponsor's protocol ID
- 5589
- Acronym
- GHREP
- Status last verified
- May 2020
- First submitted
- 14 Nov 2018
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guam Healthy Relationships Education Program
- ClinicalTrials.gov ID
- NCT03790761
- Acronym / sponsor ID
- GHREP / 5589
- Conditions
- Health Behavior
- Keywords
- Guam, healthy relationships, non-profit organization, PREP 8.0 curriculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- WestCare Pacific Islands, Inc.University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program that will foster healthy relationships and marriages on the island of Guam.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREP 8.0 Curriculum | Experimental | Behavioral: PREP 8.0 CurriculumAll participants enrolled in the program will be given the PREP 8.0 curriculum - there will be no comparison group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Under the age of 18 years
- Not in a long-term relationship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREP 8.0 CurriculumThe 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. | Behavioural | PREP 8.0 Curriculum |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Rhea, Ed.D. principal investigator
WestCare Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREP 8.0 Curriculum in people with Health Behavior, run by WestCare Pacific Islands, Inc. at 1 site in Guam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.