- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04378309
Illinois United ePREP Program Evaluation
April 29, 2021 updated by: Allen Barton, University of Illinois at Urbana-Champaign
Illinois United: ePREP Program Evaluation
The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the state of Illinois.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of the research is to evaluate the effectiveness of an online intervention for help-seeking couples designed to promote individual and couple well-being.
Within the United States, one-third of married couples are distressed and almost half of first marriages end in divorce/separation.
Relationship distress is associated with a variety of negative health outcomes, including worsened mental and physical health problems in partners as well as internalizing and externalizing problems in children.
Newly developed online intervention programs for distressed couples have shown to be efficacious, but their overall reach to the general population remains limited.
The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the state of Illinois.
Study Type
Interventional
Enrollment (Anticipated)
100
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 Contact
- Name: Allen Barton
- Phone Number: 2172442009
- Email: awbarton@illinois.edu
Study Locations
-
-
Illinois
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Urbana, Illinois, United States, 61820
- Recruiting
- University of Illinois Extension
-
Contact:
- Allen Barton
- Phone Number: 217-244-2009
- Email: awbarton@illinois.edu
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Resident of Illinois
- Married, engaged, or living with their partner for at least 6 months
- Both partners willing to participate in online relationship-focused programming
Exclusion Criteria:
- One or both partners reports severe forms of intimate partner violence occurring in the 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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ePrep
The ePREP program is the online version of the Prevention and Relationship Enhancement Program.
It consists of 6 self-directed online sessions and accompanying homework and brief coach calls.
|
6-session online psychoeducational program with supporting coach calls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Relationship Satisfaction
Time Frame: Immediate and 6-month follow-up
|
Couple Satisfaction Index
|
Immediate and 6-month follow-up
|
Change in Relationship Instability
Time Frame: Immediate and 6-month follow-up
|
3 item Relationship Instability measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology)
|
Immediate and 6-month follow-up
|
Change in Partner Support
Time Frame: Immediate and 6-month follow-up
|
5 item Partner Support measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology)
|
Immediate and 6-month follow-up
|
Change in Communication conflict
Time Frame: Immediate and 6-month follow-up
|
4 item communication conflict measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology)
|
Immediate and 6-month follow-up
|
Change in Relationship confidence
Time Frame: Immediate and 6-month follow-up
|
4 item relationship confidence measure (from Stanley et al., 1994)
|
Immediate and 6-month follow-up
|
Change in Intervention-target behavior
Time Frame: Immediate and 6-month follow-up
|
PREP 3 keys (new measure created for this study, assessing participants confidence in implementing each of the 3 keys of the PREP program)
|
Immediate and 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Partner Aggression
Time Frame: Immediate and 6-month follow-up
|
7 item partner aggression (from Doss et al., 2020, Journal of Consulting and Clinical Psychology)
|
Immediate and 6-month follow-up
|
Change in Psychological distress
Time Frame: Immediate and 6-month follow-up
|
Kessler 6 item psychological distress
|
Immediate and 6-month follow-up
|
Change in Anger
Time Frame: Immediate and 6-month follow-up
|
NIH PROMIS 5 item anger measure
|
Immediate and 6-month follow-up
|
Change in Perceived Stress
Time Frame: Immediate and 6-month follow-up
|
Cohen's 10 item perceived stress measure
|
Immediate and 6-month follow-up
|
Change in General Health
Time Frame: Immediate and 6-month follow-up
|
SF-36 4 item general health perceptions
|
Immediate and 6-month follow-up
|
Change in Insomnia
Time Frame: Immediate and 6-month follow-up
|
7 item insomnia severity index
|
Immediate and 6-month follow-up
|
Change in Problematic Alcohol Use
Time Frame: Immediate and 6-month follow-up
|
PROMIS 7 item problematic alcohol use
|
Immediate and 6-month follow-up
|
Change in Exercise
Time Frame: Immediate and 6-month follow-up
|
1 item exercise (CDC BRFSS 2016 adaptation)
|
Immediate and 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 15, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
June 30, 2025
Study Registration Dates
First Submitted
May 1, 2020
First Submitted That Met QC Criteria
May 4, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
May 3, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 20837
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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