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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06422299
Other study ID # STUDY00017992
Secondary ID K23AA031034-01
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2026
Est. completion date August 1, 2027

Study information

Verified date May 2024
Source University of Washington
Contact Katherine Walukevich-Dienst, PhD
Phone 508-282-0413
Email kwd1@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are: - Will the intervention be feasible and acceptable to young adult couples? - Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning? Eligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up. Researchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 1, 2027
Est. primary completion date August 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility Inclusion Criteria: - Both partners in the couple are 18-29 years old - In a committed romantic relationship (e.g., dating seriously, cohabiting, married) with each other for at least 3 months - Face-to-face contact their partner at least 5 days per week - Live in Washington State - Have a valid email address and access to a cell phone - Report alcohol and cannabis co-use at least three times in the past month - Willingness to: complete online surveys during the allotted time frames, receive text messages and emails from the project, complete a baseline session, and participate during the same time period as their partner Exclusion Criteria: - Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Online, couples-based intervention
During Phase 1 of the present study, the intervention will be iteratively developed using a rigorous, user-centered design approach through integration of knowledge gained from Phase 1 dyadic analyses and qualitative interviews, and existing gold-standard treatments for substance use among couples, including Integrative Behavioral Couples Therapy (IBCT; Christensen & Doss, 2016) and Behavioral Couples Therapy for Alcohol (ABCT; McCrady et al, 1995) and substance use brief interventions for young adults (Halladay, et al., 2019; Tanner-Smith et al., 2015).

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Washington National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

References & Publications (6)

Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available. — View Citation

Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572. — View Citation

Lee CM, Kilmer JR, Neighbors C, Atkins DC, Zheng C, Walker DD, Larimer ME. Indicated prevention for college student marijuana use: a randomized controlled trial. J Consult Clin Psychol. 2013 Aug;81(4):702-9. doi: 10.1037/a0033285. Epub 2013 Jun 10. — View Citation

Patrick ME, Veliz PT, Terry-McElrath YM. High-intensity and simultaneous alcohol and marijuana use among high school seniors in the United States. Subst Abus. 2017 Oct-Dec;38(4):498-503. doi: 10.1080/08897077.2017.1356421. Epub 2017 Jul 20. — View Citation

Patrick ME. A Call for Research on High-Intensity Alcohol Use. Alcohol Clin Exp Res. 2016 Feb;40(2):256-9. doi: 10.1111/acer.12945. No abstract available. — View Citation

Scott ME, Moore KA, Fish H, Benedetti A, Erikson S. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services. 2015. https://www.acf.hhs.gov/sites/default/files/documents/b_hmre_recommended_outcome_measures_for_adolescents_508_0.pdf

Outcome

Type Measure Description Time frame Safety issue
Primary Heavy episodic and high intensity drinking Alcohol use - number of days in the past month participant engaged in heavy episodic drinking (4+/5+ drinks in one occasion for women/men) and high intensity drinking (8+/10+ drinks in one occasion for women/men) Screening, baseline, approximately 5 weeks after baseline, 3-month followup
Primary Daily Drinking Questionnaire (DDQ) Alcohol use - Average total drinks per week will be calculated as the sum of the total number of drinks reported. Screening, baseline, approximately 5 weeks after baseline, 3-month followup
Primary Daily Marijuana Questionnaire (DMQ) Cannabis use - Average total hours high from cannabis per week will be calculated as the sum of the total hours high reported Screening, baseline, approximately 5 weeks after baseline, 3-month followup
Primary Intensity of Marijuana Use Cannabis use intensity - Average number of times used cannabis per day will be calculated as the mean number of times participant reports using cannabis per each day of a typical week in the past month Screening, baseline, approximately 5 weeks after baseline, 3-month followup
Primary Perceived Program Effects on Healthy Relationship Self-Efficacy items Healthy relationship self-efficacy - 3 items assessing perceived intervention impacts on healthy relationship self-efficacy scored 0=strongly disagree to 5=strongly agree. Scores will be summed, total scores will range from 0 to 15, with higher scores indicating greater healthy relationship self-efficacy Screening, baseline, approximately 5 weeks after baseline, 3-month followup
Primary Couples Satisfaction Index Relationship satisfaction - sum of 4 items ranges from 0 to 21, higher scores indicate greater relationship satisfaction Screening, baseline, approximately 5 weeks after baseline, 3-month followup
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