NCT03568565

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 7, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

June 6, 2018

Last Update Submit

September 10, 2020

Conditions

Relationship, Marital

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in Communication Conflict

    Baseline, 2 months after baseline, and 6 months after baseline

  • Relationship break-up potential

    Baseline, 2 months after baseline, and 6 months after baseline

Study Arms (5)

ePREP Program

EXPERIMENTAL

The ePREP program is based on the in-person Prevention and Relationship Enhancement Program. The ePREP program consists of six sections of material. In each section, new information and skills are presented, videos demonstrate real couples practicing the skills, participants are encouraged to discuss the information in the context of their own relationship, and a multiple choice quiz reiterates and summarizes the section. In addition to the core educational materials, couples are asked to complete six additional online and offline homework assignments (one per week), each lasting approximately one hour. Participants who do not complete activities in a timely manner will be re-randomized to either continue without a coach or to receive a coach.

Behavioral: ePREP Program

ePREP Program plus Coach

EXPERIMENTAL

The ePREP program is based on the in-person Prevention and Relationship Enhancement Program. The ePREP program consists of six sections of material. In each section, new information and skills are presented, videos demonstrate real couples practicing the skills, participants are encouraged to discuss the information in the context of their own relationship, and a multiple choice quiz reiterates and summarizes the section. In addition to the core educational materials, couples are asked to complete six additional online and offline homework assignments (one per week), each lasting approximately one hour. Couples also have four, brief video or phone calls with a coach throughout the program.

Behavioral: ePREP Program

OurRelationship Program

EXPERIMENTAL

The OurRelationship program is based on Integrative Behavioral Couple Therapy and encourages couples to select, understand, and solve a relationship problem. Partners complete the majority of the web-based program on their own and come together for three key conversations with their partner.Participants who do not complete activities in a timely manner will be re-randomized to either continue without a coach or to receive a coach.

Behavioral: OurRelationship Program

OurRelationship Program plus Coach

EXPERIMENTAL

The OurRelationship program is based on Integrative Behavioral Couple Therapy and encourages couples to select, understand, and solve a relationship problem. Partners complete the majority of the web-based program on their own and come together for three key conversations with their partner. The first conversation between partners centers on discussing possible core relationship issues and jointly deciding on the problem(s) to focus on during the program. During the second conversation, both partners' previous written responses are displayed on the screen and conversation is encouraged. During the final conversation, couples share their strategies to decrease stress, improve patterns of communication, and engage in problem-solving exercises specific to their core issue(s). Couples also have four, brief video or phone calls with a coach throughout the program.

Behavioral: OurRelationship Program

Waitlist

NO INTERVENTION

Participants are assessed at 1, 2, 4, and 6 months after randomization; however, no active intervention is given during the waitlist period.

Interventions

ePREP ProgramBEHAVIORAL

see arm descriptions

ePREP ProgramePREP Program plus Coach
OurRelationship ProgramBEHAVIORAL

see arm descriptions

OurRelationship ProgramOurRelationship Program plus Coach

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • They are married, engaged, or have been cohabiting with their partner for at least six months
  • They are both located in the United States
  • Both partners are willing to participate in the study
  • Both partners are between the ages of 18 and 64 (inclusive)
  • Couples report a household income at or below 200% of the Federal Poverty Level.

You may not qualify if:

  • Severe domestic violence
  • Inadequate internet connection
  • Previous participation in OR, PREP-O, in-person PREP, or its variants
  • Current participation in other relationship programs
  • Current participation in an evaluation funded by Administration for Children and Families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (1)

  • Le Y, Roddy MK, Rothman K, Salivar EG, Guttman S, Doss BD. A randomized controlled trial of the online OurRelationship program with varying levels of coach support. Internet Interv. 2023 Aug 28;34:100661. doi: 10.1016/j.invent.2023.100661. eCollection 2023 Dec.

    PMID: 37674656DERIVED

Related Links

Study Officials

  • Brian D Doss, Ph.D.

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: The model is a partial/limited SMART design. Couples are initially randomly assigned to one of five groups - a waitlist control, the ePREP program (with and without a coach) and the OurRelationship program (with and without a coach). Following initial randomization, couples initially assigned to complete either program without a coach and who are not completing activities in a timely manner will be re-randomized to either continue without a coach or received a coach.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 26, 2018

Study Start

June 7, 2018

Primary Completion

September 10, 2020

Study Completion

September 10, 2020

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

De-identified data will be provided to Administration for Children and Families to facilitate secondary data analyses.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified data provided to ACF within 6 months of study completion. De-identified data available to outside researchers 1.5 years after enrollment ends.
Access Criteria
Available to researchers who have approval from their local IRB.

Locations

US(1)