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
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Washington | National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH) |
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
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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