Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples

Alcohol Drinking Clinical Trial

Official title:

Developing and Testing an Online Intervention for Decreasing Alcohol and Cannabis Misuse and Increasing Healthy Relationship Skills Among Young Adult Couples: A Comprehensive Mixed-methods Approach

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
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Cannabis Use
• Couples
• Marijuana Abuse

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