Clinical trial NCT03292692: Empirically-Based Couple Interventions on the Web: Serving the Underserved
Official title: Empirically-Based Couple Interventions on the Web: Serving the Underserved
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relationship, Marital
Marital Conflict
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of California, Los Angeles
name: University of Washington
First posted: 2017-09-25
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Relationship Satisfaction
timeFrame: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
Secondary outcomes:
measure: Relationship Confidence
timeFrame: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
measure: Depressive Symptoms
timeFrame: Pre (0 weeks) and Post (approximately 6 weeks)
measure: Anxiety Symptoms
timeFrame: Pre (0 weeks) and Post (approximately 6 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.