Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-28 @ 6:00 AM
Study NCT ID:
NCT06822257
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drinking in Young Adult Duos (DYAD) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D000435', 'term': 'Alcoholic Intoxication'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D001628', 'term': 'Beverages'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 504}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social behaviors-observational', 'timeFrame': 'During couple interactions in the lab for a total duration of 55 minutes.', 'description': '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.'}, {'measure': 'Emotions', 'timeFrame': 'Immediately after the couple interactions in the lab referenced above.', 'description': '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.'}, {'measure': 'Social behaviors-self-report', 'timeFrame': 'Immediately after the couple interactions in the lab referenced above.', 'description': "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."}, {'measure': 'Real-world experiences', 'timeFrame': 'The EMA protocol will be completed for 14 days post-lab session.', 'description': "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)."}, {'measure': 'Longer term alcohol problems', 'timeFrame': 'Assessed longitudinally up to 12-months post-lab session.', 'description': 'Follow-up sessions will assess alcohol problems using DSM-5 alcohol use disorder criteria. Higher scores reflect more alcohol problems.'}], 'secondaryOutcomes': [{'measure': 'Relationship functioning', 'timeFrame': 'Assessed longitudinally up to 12-months post-lab session.', 'description': 'Relationship functioning will be assessed on 10 point Likert scales (Jakubiak \\& Feeney, 2009), with higher scores representing higher relationship functioning.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol administration', 'couples'], 'conditions': ['Alcohol Consumption', 'Alcohol Drinking', 'Alcohol Intoxication']}, 'descriptionModule': {'briefSummary': 'This study examines the role of alcohol use in understanding the dynamics of romantic relationships. Couples will participate in a research session where they consume either an alcoholic or non-alcoholic beverage and complete study tasks. After the session, participants will provide information about their drinking habits, alcohol- and non-alcohol-related experiences, and relationship factors through brief surveys on their smart phones and again at 6-month and 12-month follow-up sessions. The findings from this study aim to improve understanding of alcohol use in close relationships and may inform future strategies for promoting healthier relationships and behaviors.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBoth members of the couple must:\n\n* be between the ages of 21 and 30\n* regularly consume alcohol\n* own a smartphone\n\nExclusion Criteria:\n\nNeither member of the couple:\n\n* has a history of adverse reaction to the amount of beverage used in the study\n* has a history of major problems related to alcohol\n* is taking medications that could adversely interact with alcohol\n* is pregnant'}, 'identificationModule': {'nctId': 'NCT06822257', 'briefTitle': 'Drinking in Young Adult Duos (DYAD) Study', 'organization': {'class': 'OTHER', 'fullName': 'Carnegie Mellon University'}, 'officialTitle': 'Understanding Alcohol Use in Young Adult Couples', 'orgStudyIdInfo': {'id': 'AA031009'}, 'secondaryIdInfos': [{'id': 'R01AA031009', 'link': 'https://reporter.nih.gov/quickSearch/R01AA031009', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy couples who drink alcohol', 'description': 'Healthy young adult couples who regularly drink alcohol', 'interventionNames': ['Drug: Alcohol beverage', 'Other: Non-alcohol beverage']}], 'interventions': [{'name': 'Alcohol beverage', 'type': 'DRUG', 'description': 'moderate dose of alcohol', 'armGroupLabels': ['Healthy couples who drink alcohol']}, {'name': 'Non-alcohol beverage', 'type': 'OTHER', 'description': 'No alcohol given', 'armGroupLabels': ['Healthy couples who drink alcohol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kasey Creswell, PhD', 'role': 'CONTACT', 'email': 'kasey@andrew.cmu.edu', 'phone': '1-412-779-4931'}, {'name': 'Kasey G. Creswell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carnegie Mellon University', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Kasey G. Creswell, PhD', 'role': 'CONTACT', 'email': 'kasey@andrew.cmu.edu', 'phone': '412-779-4931'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared in the NIAAA Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carnegie Mellon University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychology; Director of Graduate Studies', 'investigatorFullName': 'Kasey Creswell', 'investigatorAffiliation': 'Carnegie Mellon University'}}}}