## Protocol Section
### Identification Module
**NCT ID:** NCT06422299

**Brief Title:** 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

#### Organization Study ID Info
**ID:** STUDY00017992
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
#### Secondary ID Infos
**ID:** K23AA031034-01
**Link:** https://reporter.nih.gov/quickSearch/K23AA031034-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2026-07-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-08
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institutes of Health (NIH)

**Class:** NIH

**Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Washington

#### Responsible Party

**Investigator Affiliation:** University of Washington

**Investigator Full Name:** Katherine Walukevich-Dienst

**Investigator Title:** Acting Assistant Professor, School of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Alcohol Drinking

- Cannabis Use

- Couples

**Keywords:**

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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Online, couples-based intervention

**Label:** Online, couples-based intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Couples in the control condition will not receive an intervention.

**Label:** Assessment-only control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Online, couples-based intervention

**Description:** 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).

**Name:** Online, couples-based intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Heavy episodic and high intensity drinking

**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup

**Description:** Alcohol use - Average total drinks per week will be calculated as the sum of the total number of drinks reported.

**Measure:** Daily Drinking Questionnaire (DDQ)

**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup

**Description:** Cannabis use - Average total hours high from cannabis per week will be calculated as the sum of the total hours high reported

**Measure:** Daily Marijuana Questionnaire (DMQ)

**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup

**Description:** 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

**Measure:** Intensity of Marijuana Use

**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup

**Description:** 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

**Measure:** Perceived Program Effects on Healthy Relationship Self-Efficacy items

**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup

**Description:** Relationship satisfaction - sum of 4 items ranges from 0 to 21, higher scores indicate greater relationship satisfaction

**Measure:** Couples Satisfaction Index

**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 29 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kwd1@uw.edu

**Name:** Katherine Walukevich-Dienst, PhD

**Phone:** 508-282-0413

**Role:** CONTACT

**Contact 2:**

**Name:** Hana Basu, BA

**Phone:** 425-372-6459

**Role:** CONTACT

### References Module

#### 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.

**PMID:** 26842244

**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.

**PMID:** 3998247

**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.

**PMID:** 23750464

**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.

**PMID:** 28726580

**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.

**PMID:** 18179329

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000004327

- Term: Drinking Behavior

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M3774

- Name: Alcohol Drinking

- Relevance: HIGH

- As Found: Alcohol Drinking

- ID: M5449

- Name: Marijuana Abuse

- Relevance: HIGH

- As Found: Cannabis

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7502

- Name: Drinking Behavior

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002189

- Term: Marijuana Abuse

- ID: D000000428

- Term: Alcohol Drinking

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
