Healthy MarriageNCT03076229
Relationship Education:Project Harmony
A study testing Healthy Marriage Program in people with Healthy Marriage, run by University of Central Florida at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of relationship education (RE) for individuals and couples participating in Project Harmony. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Marriage
- What is being tested?
- Healthy Marriage Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 29 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals and couples who are at least 18 years of age.
Who cannot join
- Does not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Marriage
- Being tested
- Healthy Marriage Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Marriage ProgramBehavioural
Provide the following allowable activities 1) marriage and relationship education/skills, 2) relationship enhancement, 3) premarital education, and 4) divorce reduction.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Marriage: Treatment | Experimental | Intervention: Behavioral: Healthy Marriage Program Receives: Behavioral: Healthy Marriage Program |
| Healthy Marriage: Wait-list Control | Experimental | Intervention: Behavioral: Healthy Marriage Program Receives: Behavioral: Healthy Marriage Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
1200 participants with relational and interpersonal stressors
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)?
Measured: 6 months
Secondary outcomes (1)
1200 participants with relational and interpersonal stressors
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)?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startJul 2016
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MarriageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Sejal M Barden, PhD, Principal investigator, University of Central FloridaBridgette Toussaint, MS, Study director, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076229
- Sponsor's protocol ID
- UCF MFRI
- Status last verified
- Jun 2021
- First submitted
- 8 Feb 2017
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Relationship Education: Project Harmony
- ClinicalTrials.gov ID
- NCT03076229
- Acronym / sponsor ID
- UCF MFRI
- Conditions
- Healthy Marriage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Jul 2016 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 10 Mar 2017 (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 purpose of this study is to evaluate the effectiveness of relationship education (RE) for individuals and couples participating in Project Harmony.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Marriage: Treatment | Experimental | Behavioral: Healthy Marriage ProgramIntervention: Behavioral: Healthy Marriage Program |
| Healthy Marriage: Wait-list Control | Experimental | Behavioral: Healthy Marriage ProgramIntervention: Behavioral: Healthy Marriage Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals and couples who are at least 18 years of age.
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria
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 |
|---|---|---|
| Healthy Marriage ProgramProvide the following allowable activities 1) marriage and relationship education/skills, 2) relationship enhancement, 3) premarital education, and 4) divorce reduction. | Behavioural | Healthy Marriage: Treatment, Healthy Marriage: Wait-list Control |
Primary outcome
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)?
1 secondary outcome
1200 participants with relational and interpersonal stressors
Time frame: 6 months
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 30 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Sejal M Barden, PhD principal investigator
University of Central Florida
Bridgette Toussaint, MS study director
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Marriage Program in people with Healthy Marriage, run by University of Central Florida at 1 site in United States.
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 1 inclusion and 1 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 30 Jun 2021. 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 United States. 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?
1200 participants with relational and interpersonal stressors (time frame: 6 months). 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 30 Jun 2021.