Relationship, MaritalNCT03568565
Automated & Coached Web-based Programs to Improve and Strengthen Romantic Relationships
A study testing ePREP Program and OurRelationship Program in people with Relationship, Marital, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Relationship, Marital
- What is being tested?
- ePREP Program and OurRelationship Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 10 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web-based Marriage Preparation/Enrichment and Divorce Prevention for Low-Income Couples
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.
Read the detailed 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.
- Conditions
- Relationship, Marital
- Being tested
- ePREP Program, OurRelationship Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePREP ProgramBehavioural
see arm descriptions
OurRelationship ProgramBehavioural
see arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 months after baseline, and 6 months after baseline
Secondary outcomes (2)
Change in Communication Conflict
7-item scale; self-report of communication conflict. Range of scores 7 to 28, with higher scores indicating greater conflict.
Measured: Baseline, 2 months after baseline, and 6 months after baseline
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.
Measured: Baseline, 2 months after baseline, and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start7 Jun 2018
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relationship, MaritalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Responsible party
- Principal investigator, Brian D Doss, University of Miami
- Investigators
- Brian D Doss, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568565
- Sponsor's protocol ID
- 20160451-R
- Status last verified
- Sep 2020
- First submitted
- 6 Jun 2018
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be provided to Administration for Children and Families to facilitate secondary data analyses.
Publications
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.
PubMed 37674656
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Marriage Preparation/Enrichment and Divorce Prevention for Low-Income Couples
- ClinicalTrials.gov ID
- NCT03568565
- Acronym / sponsor ID
- 20160451-R
- Conditions
- Relationship, Marital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 26 Jun 2018 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ePREP Program | Experimental | Behavioral: ePREP ProgramThe 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. |
| ePREP Program plus Coach | Experimental | Behavioral: ePREP ProgramThe 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. |
| OurRelationship Program | Experimental | Behavioral: OurRelationship ProgramThe 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. |
| OurRelationship Program plus Coach | Experimental | Behavioral: OurRelationship ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ePREP Programsee arm descriptions | Behavioural | ePREP Program, ePREP Program plus Coach |
| OurRelationship Programsee arm descriptions | Behavioural | OurRelationship Program, OurRelationship Program plus Coach |
Primary outcome
Change in Relationship Satisfaction
Time frame: Baseline, 2 months after baseline, and 6 months after baseline
Four-item Couple Satisfaction Index (CSI) self-report measure. Range of scores 0 to 21, with higher scores indicating greater satisfaction.
2 secondary outcomes
Change in Communication Conflict
Time frame: Baseline, 2 months after baseline, and 6 months after baseline
Relationship break-up potential
Time frame: Baseline, 2 months after baseline, and 6 months after baseline
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 14 Sep 2020.
- Derived from this study: PubMed 37674656Le 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.
- To learn more about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be provided to Administration for Children and Families to facilitate secondary data analyses.
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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.
Brian D Doss, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePREP Program and OurRelationship Program in people with Relationship, Marital, run by University of Miami 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 5 inclusion and 5 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 14 Sep 2020. 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?
Change in Relationship Satisfaction (time frame: Baseline, 2 months after baseline, and 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568565, which also lists 1 linked publication.
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 14 Sep 2020.