Strong Couples Project: Disseminating Evidence-based Relationship Education

October 19, 2022 updated by: University of Illinois at Urbana-Champaign

Strong Couples Project: ePREP Nationwide Dissemination

The current research is designed to implement and evaluate the ePREP relationship intervention with couples via the Cooperative Extension system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of the research is to evaluate the effectiveness of an online intervention (ePREP) for help-seeking couples designed to promote individual and couple well-being. 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 nation in a manner that allows for scalable, sustainable program delivery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61820
        • University of Illinois Extension
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 116 years (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 sever 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ePREP condition
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.
Behavioral: ePREP
6-session online psychoeducational program with supporting coach calls

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in relationship satisfaction
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Couple satisfaction index
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in relationship instability
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
3 item Relationship Instability measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in partner support
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
5 item Partner Support measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in communication conflict
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
4 item communication conflict measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in relationship confidence
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
4 item relationship confidence measure (from Stanley et al., 1994)
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in intervention-targeted behavior
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
PREP 3 keys and Couple Communal Identity (new measures created for this study)
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in partner aggression
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
7 item partner aggression (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in psychological distress
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Kessler 6 item psychological distress
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in anger
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
NIH PROMIS 5 item anger measure
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in perceived stress
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Cohen's 10 item perceived stress measure
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in general health
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Short Form-36 4 item general health perceptions
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in insomnia
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
7 item insomnia severity index
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in problematic alcohol use
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 7 item problematic alcohol use
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in exercise
Time Frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
1 item exercise (Behavioral Risk Factor Surveillance System 2016 adaptation)
Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21550

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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