- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06822257
Drinking in Young Adult Duos (DYAD) Study
Understanding Alcohol Use in Young Adult Couples
Study Overview
Status
Intervention / Treatment
Detailed Description
This study investigates alcohol consumption in romantic relationships. Couples will be recruited to participate in a laboratory-based alcohol administration session, during which they will consume either a moderate dose of alcohol or a non-alcoholic beverage. Following beverage consumption, couples will complete questionnaires and tasks.
The study employs a multi-method approach to assess alcohol in couples, including self-reports and behavioral tasks, both inside and outside of the lab (e.g., using ecological momentary assessment). Additionally, participants' drinking patterns and relationship factors will be tracked over time, with follow-up assessments conducted at 6-months and 12 months post-laboratory session.
The findings from this research will provide insights into the role that alcohol consumption plays in close relationships and may inform interventions to support healthier drinking behaviors and relationship outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kasey G. Creswell, PhD
- Phone Number: 412-779-4931
- Email: kasey@andrew.cmu.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- Carnegie Mellon University
-
Principal Investigator:
- Kasey G. Creswell, PhD
-
Contact:
- Kasey Creswell, PhD
- Phone Number: 1-412-779-4931
- Email: kasey@andrew.cmu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Both members of the couple must:
- be between the ages of 21 and 30
- regularly consume alcohol
- own a smartphone
Exclusion Criteria:
Neither member of the couple:
- has a history of adverse reaction to the amount of beverage used in the study
- has a history of major problems related to alcohol
- is taking medications that could adversely interact with alcohol
- is pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy couples who drink alcohol
Healthy young adult couples who regularly drink alcohol
|
moderate dose of alcohol
No alcohol given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social behaviors-observational
Time Frame: During couple interactions in the lab for a total duration of 55 minutes.
|
Behavioral measures of social processes using validated and reliable behavioral coding schemes to code facial expressions, speech behaviors, and speech content: the Facial Action Coding System (Ekman, Friesen, & Hagar, 2002) and the Rapid Marital Interaction Coding System (Heyman, 2004).
This coding uses binary (yes/no) codes for presence/absence of behaviors at each moment in time.
Higher scores represent more instances of behaviors.
|
During couple interactions in the lab for a total duration of 55 minutes.
|
|
Emotions
Time Frame: Immediately after the couple interactions in the lab referenced above.
|
The 8-item Mood Measure (Fairbairn et al., 2021) will assess self-reported positive and negative emotions on scales from 0 (none) to 10 (extremely).
Higher scores indicate a greater intensity of emotions.
|
Immediately after the couple interactions in the lab referenced above.
|
|
Social behaviors-self-report
Time Frame: Immediately after the couple interactions in the lab referenced above.
|
Participants will provide ratings of their own and their partners' social behaviors on ten-point Likert scales.
Higher scores indicate a greater endorsement of each behavior.
|
Immediately after the couple interactions in the lab referenced above.
|
|
Real-world experiences
Time Frame: The EMA protocol will be completed for 14 days post-lab session.
|
Ecological Momentary Assessment (EMA) methods will be used to send a series of brief surveys to participants' smartphones to assess alcohol consumption (in standard alcoholic drinks).
|
The EMA protocol will be completed for 14 days post-lab session.
|
|
Longer term alcohol problems
Time Frame: Assessed longitudinally up to 12-months post-lab session.
|
Follow-up sessions will assess alcohol problems using DSM-5 alcohol use disorder criteria.
Higher scores reflect more alcohol problems.
|
Assessed longitudinally up to 12-months post-lab session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship functioning
Time Frame: Assessed longitudinally up to 12-months post-lab session.
|
Relationship functioning will be assessed on 10 point Likert scales (Jakubiak & Feeney, 2009), with higher scores representing higher relationship functioning.
|
Assessed longitudinally up to 12-months post-lab session.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA031009
- R01AA031009 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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