Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:28 PM
Study NCT ID:
NCT07463118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Game-Based Intervention to Reduce Alcohol Use Among Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-armed parallel randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1992}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol-related harms', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Participants report how many times they experienced 19 different alcohol-related harms, based on the measure from the the School Health and Alcohol Harm Reduction Project (SHAHRP). Example harms include hangover after drinking, inability to remember what happened after drinking, having sex that they later regretted, trouble with parent(s) because of drinking, physical fight because they were affected by alcohol, and drove in a vehicle after drinking. Response options for each harm range from "never" (0) to "12 times or more" (12). Scores range from 0 to 228, with higher scores indicating more alcohol-related harms.'}], 'secondaryOutcomes': [{'measure': 'Drinking quantity', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Number of drinks consumed on a typical day of drinking assessed via Quantity-Frequency items'}, {'measure': 'Drinking frequency', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Number of days on which one or more drinks were consumed assessed via Quantity-Frequency items.'}, {'measure': 'Binge drinking frequency', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Number of times when 4 or 5+ drinks (asking both regardless of assigned/biological sex at birth) were consumed in a 2-hour period assessed via National Institute on Alcohol Abuse and Alcoholism (NIAAA) items.'}, {'measure': 'Alcohol use initiation', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Participants report whether or not they drank alcohol, which is assessed via the Youth Risk Behavior Survey item about lifetime alcohol use.'}, {'measure': 'Alcohol protective behavioral strategies', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Which alcohol protective behavioral strategies are engaged in while drinking or partying, measured with the Protective Behavioral Strategies Scale (PBSS). Scores range from 20 to 120, with higher scores indicating more skills used.'}, {'measure': 'Bystander alcohol risk reduction skills', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Total number of times specific strategies were used to help others before, during, or after drinking, using the Strategies subscale of the Bystanders to Alcohol Risk Scale (BARS). Scores range from 0 to 27, with higher scores indicating more skills used.'}, {'measure': 'Emotional distress tolerance skills', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Ability to endure negative emotional states, measured with the Distress Tolerance Scale (DTS). Scores range from 15 to 75, with higher scores indicating better distress tolerance.'}, {'measure': 'Emotion regulation and decentering practices', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'How often mindfulness practices are used, measured with the Applied Mindfulness Process Scale (AMPS). Scores range from 0 to 60, with higher scores indicating a better outcome.'}, {'measure': 'Healthy social media use', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': "Using MetroWest Adolescent Health Survey items, this self-report measure assesses adolescents' perceptions of the social, emotional, and behavioral impacts of social media use. Participants indicate their level of agreement with 11 statements on a 5-point Likert scale, with higher average scores reflecting healthier social media use."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Problem']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial to learn if the Singularities, a game-based intervention, works to reduce alcohol-related harms among youth. It will also learn if Singularities reduces alcohol use behaviors and improves alcohol protective behavioral strategies, adaptive coping skills, and healthy social media use. The main questions it aims to answer are:\n\n* Does Singularities reduce the frequency of experiencing alcohol-related harms and alcohol use behaviors?\n* Does Singularities improve alcohol protective behavioral strategies, adaptive coping skills, and healthy social media use?\n\nResearchers will compare Singularities to an attention control program, Food4Thought, a game-based intervention about nutrition, physical activity, and teen well-being, to see if Singularities works to reduce alcohol-related harms.\n\nParticipants will:\n\n* Partake in either Singularities or Food4Thought, both of which will be completed over the course of one month\n* Take 4 online surveys over the course of one year\n* Complete an optional online interview after the surveys'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to comfortably participate in English\n* Live in the U.S.\n* 14-18 years old\n* Have an internet-accessible computer, smart phone, or tablet\n* Provide an email address\n* Have drank alcohol in their lifetime or intend to in the next year\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT07463118', 'briefTitle': 'Game-Based Intervention to Reduce Alcohol Use Among Youth', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Randomized Controlled Trial of a Game-Based Intervention to Reduce Alcohol Use Among Youth', 'orgStudyIdInfo': {'id': 'STUDY25100213'}, 'secondaryIdInfos': [{'id': '5R01AA030017-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01AA030017-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Singularities', 'description': 'Singularities is a theory-based, community-informed, web-accessible intervention that includes a game, discussion board, and resources that incorporate 3 components for encouraging use of adaptive coping skills, alcohol protective behavioral strategies, and healthy internet and social media use.', 'interventionNames': ['Behavioral: Singularities']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Food4Thought', 'description': 'Food4Thought is an attention control condition in which participants receive similar amounts of research team contact and program contact as the Singularities intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center, and learn about resources and respond to questions about nutrition, physical activity, and teen well-being (without the mention of anything pertaining to alcohol use).', 'interventionNames': ['Behavioral: Food4Thought']}], 'interventions': [{'name': 'Food4Thought', 'type': 'BEHAVIORAL', 'description': 'Food4Thought is an attention control condition in which participants receive similar amounts of research team contact and program contact as the intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center. Participants are instructed to build healthy meals using cuisine from around the world while ensuring they stick to a budget and meet all their nutritional needs. Food4Thought will be delivered via Qualtrics.', 'armGroupLabels': ['Food4Thought']}, {'name': 'Singularities', 'type': 'BEHAVIORAL', 'description': 'Singularities is a theory-based, community-informed, web-accessible intervention that includes a game, discussion board, and resources that incorporate 3 components for encouraging use of adaptive coping skills, alcohol protective behavioral strategies, and healthy internet and social media use.', 'armGroupLabels': ['Singularities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Robert WS Coulter, PhD, MPH', 'role': 'CONTACT', 'email': 'robert.ws.coulter@pitt.edu', 'phone': '412-624-0647'}, {'name': 'James E Egan, PhD, MPH', 'role': 'CONTACT', 'email': 'jee48@pitt.edu', 'phone': '412-624-2255'}], 'overallOfficials': [{'name': 'Robert WS Coulter, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/niaaa', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'IPD will be available 12 months after the end of the study. There is no end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Anyone who wishes to access the data and supporting information from the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAA DA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Robert Coulter', 'investigatorAffiliation': 'University of Pittsburgh'}}}}