- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06422299
Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katherine Walukevich-Dienst, PhD
- Phone Number: 508-282-0413
- Email: kwd1@uw.edu
Study Contact Backup
- Name: Hana Basu, BA
- Phone Number: 425-372-6459
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online, couples-based intervention
A novel, brief online intervention for young adults community couples who engage in alcohol and cannabis co-use.
|
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).
|
|
No Intervention: Assessment-only control
Couples in the control condition will not receive an intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heavy episodic and high intensity drinking
Time Frame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
|
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)
Time Frame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
|
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)
Time Frame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
|
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
Time Frame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
|
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
Time Frame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
|
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
Time Frame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
|
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
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00017992
- K23AA031034-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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