Clinical trial NCT06422299: Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Cannabis Use
Couples
Keywords: alcohol use, cannabis use, couples, healthy relationships, young adults
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Heavy episodic and high intensity drinking
timeFrame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
measure: Daily Drinking Questionnaire (DDQ)
timeFrame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
measure: Daily Marijuana Questionnaire (DMQ)
timeFrame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
measure: Intensity of Marijuana Use
timeFrame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
measure: Perceived Program Effects on Healthy Relationship Self-Efficacy items
timeFrame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
measure: Couples Satisfaction Index
timeFrame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.
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.
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
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.