NCT06422299

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

February 8, 2024

Last Update Submit

May 4, 2026

Conditions

Keywords

alcohol use, cannabis use, couples, healthy relationships, young adults

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Online, couples-based intervention

EXPERIMENTAL

A novel, brief online intervention for young adults community couples who engage in alcohol and cannabis co-use.

Behavioral: Online, couples-based intervention

Assessment-only control

NO INTERVENTION

Couples in the control condition will not receive an intervention.

Interventions

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).

Online, couples-based intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 26842244BACKGROUND
  • 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.

    PMID: 3998247BACKGROUND
  • 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.

    PMID: 23750464BACKGROUND
  • 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.

    PMID: 28726580BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 18179329BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Central Study Contacts

Katherine Walukevich-Dienst, PhD

CONTACT

Hana Basu, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Acting Assistant Professor, School of Medicine

Study Record Dates

First Submitted

February 8, 2024

First Posted

May 20, 2024

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05