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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03568565
Other study ID # 20160451-R
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2018
Est. completion date September 10, 2020

Study information

Verified date September 2020
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the effectiveness of self-help, web-based programs to improve romantic relationships and related outcomes. Couples will be randomly assigned to complete the OurRelationship program, the ePREP program, the OurRelationship program with the addition of a coach, the ePREP program with the addition of a coach, or a wait-list control group and followed for six months.


Description:

Nationwide, lower-income (LI) couples (those with household incomes <200% of the federal poverty level) - many of whom are also African American, Hispanic/Latino, or rural couples - face numerous challenges to their relationships. Chief amongst those challenges are: 1) higher risk of relationship problems and 2) lack of access to effective relationship services to prevent or intervene with relationship distress. Compared to higher-income couples, LI married and cohabiting couples are significantly more likely to divorce or separate and report lower relationship quality. Unfortunately, LI couples are least likely to receive interventions to prevent or solve relationship problems. To overcome these barriers, we propose to test the effectiveness of two effective web-based curricula - OurRelationship and PREP Online.

A total of 1,246 LI couples will be recruited nationwide and randomly assigned to the ePREP program, the OurRelationship program, the ePREP program plus a coach, the OurRelationship program plus a coach, or a wait-list control group and followed for six months. Once randomly assigned to group, couples will be assessed at one month, two months, four months, and six months following randomization. After couples randomized to the wait-list control group finish their waiting period, they will be able to select the program they would like to complete (OurRelationship or ePREP) but will not complete research assessments during or following their participation in the program.


Recruitment information / eligibility

Status Completed
Enrollment 2500
Est. completion date September 10, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

1. They are married, engaged, or have been cohabiting with their partner for at least six months

2. They are both located in the United States

3. Both partners are willing to participate in the study

4. Both partners are between the ages of 18 and 64 (inclusive)

5. Couples report a household income at or below 200% of the Federal Poverty Level.

Exclusion Criteria:

1. Severe domestic violence

2. Inadequate internet connection

3. Previous participation in OR, PREP-O, in-person PREP, or its variants

4. Current participation in other relationship programs

5. Current participation in an evaluation funded by Administration for Children and Families

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ePREP Program
see arm descriptions
OurRelationship Program
see arm descriptions

Locations

Country Name City State
United States University of Miami Coral Gables Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Children's Bureau - Administration for Children and Families

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Relationship Satisfaction Four-item Couple Satisfaction Index (CSI) self-report measure. Range of scores 0 to 21, with higher scores indicating greater satisfaction. Baseline, 2 months after baseline, and 6 months after baseline
Secondary Change in Communication Conflict 7-item scale; self-report of communication conflict. Range of scores 7 to 28, with higher scores indicating greater conflict. Baseline, 2 months after baseline, and 6 months after baseline
Secondary Relationship break-up potential 3-item self-report measure of likelihood of relationship ending in the near future. Range of scores 3 to 15, with higher scores indicating greater potential for the relationship to end. Baseline, 2 months after baseline, and 6 months after baseline
See also
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Completed NCT03163082 - Couple Interaction and Health Behaviors N/A
Enrolling by invitation NCT05097833 - Local Evaluation of the Saint Francis Ministries Fatherhood FIRE Program N/A
Completed NCT03332875 - OurRelationship.Com Effectiveness Study N/A
Completed NCT04686838 - REmote Assessment and Dynamic Response Intervention II N/A
Completed NCT03292692 - Empirically-Based Couple Interventions on the Web: Serving the Underserved N/A
Completed NCT04542109 - REmote Assessment and Dynamic Response Intervention N/A

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