Alcohol DrinkingNCT06422299
Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples
A study testing Online, couples-based intervention in people with Alcohol Drinking and Cannabis Use, run by University of Washington.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Cannabis Use, Couples
- What is being tested?
- Online, couples-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hana Basu, BA contact
About this study
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?
Read more
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.
- Conditions
- Alcohol Drinking, Cannabis Use, Couples
- Being tested
- Online, couples-based intervention
- Keywords
- alcohol use, cannabis use, couples, healthy relationships, young adults
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online, couples-based interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Online, couples-based intervention | Experimental | A novel, brief online intervention for young adults community couples who engage in alcohol and cannabis co-use. Receives: Behavioral: Online, couples-based intervention |
| Assessment-only control | No intervention | Couples in the control condition will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Screening, baseline, approximately 5 weeks after baseline, 3-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Katherine Walukevich-Dienst, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422299
- Sponsor's protocol ID
- STUDY00017992
- Other IDs
- K23AA031034-01
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26842244Collins 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.
PubMed 3998247Lee 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.
PubMed 23750464Patrick 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.
PubMed 28726580Scott 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
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.
PubMed 18179329
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06422299
- Acronym / sponsor ID
- STUDY00017992
- Conditions
- Alcohol Drinking, Cannabis Use, Couples
- Keywords
- alcohol use, cannabis use, couples, healthy relationships, young adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online, couples-based intervention | Experimental | Behavioral: Online, couples-based interventionA novel, brief online intervention for young adults community couples who engage in alcohol and cannabis co-use. |
| Assessment-only control | No intervention | –Couples in the control condition will not receive an intervention. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online, couples-based interventionDuring 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). | Behavioural | Online, couples-based intervention |
Primary outcome
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)
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.
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 26842244Patrick 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.
- Background: PubMed 3998247Collins 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.
- Background: PubMed 23750464Lee 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.
- Background: PubMed 28726580Patrick 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.
- BackgroundScott 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: PubMed 18179329Funk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hana Basu, BA contact
Questions about this trial
What is this clinical trial studying?
A study testing Online, couples-based intervention in people with Alcohol Drinking and Cannabis Use, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Walukevich-Dienst, PhD (508-282-0413, kwd1@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy episodic and high intensity drinking (time frame: Screening, baseline, approximately 5 weeks after baseline, 3-month followup). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422299, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.