Empirically-Based Couple Interventions on the Web: Serving the Underserved

• ClinicalTrials.gov Identifier: NCT03292692
• Recruitment Status: Completed
• First Posted: September 25, 2017
• Results First Posted: February 12, 2018
• Last Update Posted: February 12, 2018
• Sponsor: University of Miami
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of California, Los Angeles; University of Washington
• Information provided by (Responsible Party): Brian Doss, University of Miami

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Relationship, Marital; Marital Conflict	Behavioral: OurRelationship	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Empirically-Based Couple Interventions on the Web: Serving the Underserved
• Actual Study Start Date: August 13, 2013
• Actual Primary Completion Date: October 18, 2014
• Actual Study Completion Date: October 18, 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: OurRelationship; Online Intervention	Behavioral: OurRelationship; Online intervention with coach support; Other Name: OurRelationship.com
No Intervention: Waitlist Control; 2 month waiting period before couples can receive intervention

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Brian Doss, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03292692
• Other Study ID Numbers: 20120378; R01HD059802 ( U.S. NIH Grant/Contract )
• First Posted: September 25, 2017
• Results First Posted: February 12, 2018
• Last Update Posted: February 12, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified data available to qualified researchers upon request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Available 2018-2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No