- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03292692
Empirically-Based Couple Interventions on the Web: Serving the Underserved
Although several empirically-supported interventions to prevent and treat relationship distress have been developed, the majority of couples - especially high-risk couples - do not seek these face-to-face interventions. However, our pilot data indicate that large numbers of couples will seek self-administered assistance for their relationship. Additionally, unlike many in-person interventions, couples seeking self-help resources tend to have higher levels of relationship distress. Thus, to improve the reach of couple interventions, this project will translate a leading empirically-supported intervention targeting early signs of relationship distress into a Web-based format. This intervention will consist of individualized feedback and professionally-filmed video clips tailored to a couple's specific needs. By intervening effectively with a large number of couples, the resulting Web-based intervention has the potential to have a population-level impact on relationship distress, divorce, and resulting child difficulties.
In the proposed project, building off our previous pilot studies, effective translation of this in-person intervention into a Web-based format will be ensured by conducting two additional intensive pilot studies. Once final changes have been made to the website and Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or an online intervention. All couples will be assessed for the initial two months; intervention couples will be assessed for one year. This project will: 1) demonstrate that couples randomly assigned to the online intervention will report higher levels of individual, child, and relationship functioning than those in the wait-list control group; 2) document the mechanisms of both active conditions; and 3) show that initial gains in those assigned to the intervention are largely maintained through one-year follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently in a heterosexual relationship
- Currently married, engaged, or cohabiting for at least 6 months
- At least one partner scoring in distressed range of relationship satisfaction (or both partners > 0.5 SD of population mean of distress).
- Living in the United States
- Both partners ages 21-64 (inclusive)
Exclusion Criteria:
- Severe Intimate Partner Violence in last 3 months
- Moderate to severe suicidal ideation in last 3 months
- Concrete plans to divorce
- Ongoing affair
- Ongoing couple therapy (or refusal to seek couple therapy for 3 months)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OurRelationship
Online Intervention
|
Online intervention with coach support
Other Names:
|
No Intervention: Waitlist Control
2 month waiting period before couples can receive intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship Satisfaction
Time Frame: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
|
Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk & Rogge, 2007; doi: 10.1037/0893-3200.21.4.572).
Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.
|
Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship Confidence
Time Frame: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
|
Relationship confidence as measured by 2 items from the Confidence Scale ("I believe we can handle whatever conflicts will arise in the future" and "I feel good about our prospects to make this relationship work").
Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88.
These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi
.org/10.1177/0192513X08324388).
|
Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
|
Depressive Symptoms
Time Frame: Pre (0 weeks) and Post (approximately 6 weeks)
|
Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, & Kaufman, 2004).
The total score was used, with possible scores ranging from 0-30.
Higher scores on this measure indicate greater depressive symptoms.
|
Pre (0 weeks) and Post (approximately 6 weeks)
|
Anxiety Symptoms
Time Frame: Pre (0 weeks) and Post (approximately 6 weeks)
|
Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006).
The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms.
Cronbach's alpha in the present sample was .91.
|
Pre (0 weeks) and Post (approximately 6 weeks)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Doss BD, Cicila LN, Georgia EJ, Roddy MK, Nowlan KM, Benson LA, Christensen A. A randomized controlled trial of the web-based OurRelationship program: Effects on relationship and individual functioning. J Consult Clin Psychol. 2016 Apr;84(4):285-96. doi: 10.1037/ccp0000063. Epub 2016 Jan 25.
- Roddy MK, Georgia EJ, Doss BD. Couples with Intimate Partner Violence Seeking Relationship Help: Associations and Implications for Self-Help and Online Interventions. Fam Process. 2018 Jun;57(2):293-307. doi: 10.1111/famp.12291. Epub 2017 Apr 20.
- Roddy MK, Stamatis CA, Rothman K, Doss BD. Mechanisms of change in a brief, online relationship intervention. J Fam Psychol. 2020 Feb;34(1):57-67. doi: 10.1037/fam0000569. Epub 2019 Aug 5.
- Doss BD, Roddy MK, Llabre MM, Georgia Salivar E, Jensen-Doss A. Improvements in coparenting conflict and child adjustment following an online program for relationship distress. J Fam Psychol. 2020 Feb;34(1):68-78. doi: 10.1037/fam0000582. Epub 2019 Aug 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20120378
- R01HD059802 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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