Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-02 @ 7:05 AM
Study NCT ID:
NCT05145868
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2021-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Just-In-Time Intervention to Reduce Alcohol-Facilitated Intimate Partner Violence Perpetration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D000374', 'term': 'Aggression'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D000068356', 'term': 'Self-Control'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2021-11-11', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Use', 'timeFrame': '30 days', 'description': 'Drinking Quantity (number of drinks consumed)'}, {'measure': 'Alcohol Use', 'timeFrame': '1-month follow-up', 'description': 'Drinking Quantity (number of drinks consumed)'}, {'measure': 'Alcohol Use', 'timeFrame': '3-month follow-up', 'description': 'Drinking Quantity (number of drinks consumed)'}, {'measure': 'Alcohol Use', 'timeFrame': '6-month follow-up', 'description': 'Drinking Quantity (number of drinks consumed)'}, {'measure': 'Intimate Partner Violence', 'timeFrame': '30 days', 'description': 'Occurrence (yes/no) of psychological or physical Aggression against an intimate partner'}, {'measure': 'Intimate Partner Violence', 'timeFrame': '1-month follow-up', 'description': 'Frequency of Psychological or Physical Aggression against an intimate partner'}, {'measure': 'Intimate Partner Violence', 'timeFrame': '3-month follow-up', 'description': 'Frequency of Psychological or Physical Aggression against an intimate partner'}, {'measure': 'Intimate Partner Violence', 'timeFrame': '6-month follow-up', 'description': 'Frequency of Psychological or Physical Aggression against an intimate partner'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking', 'Aggression', 'Emotion Regulation']}, 'descriptionModule': {'briefSummary': 'Acute alcohol intoxication is a robust predictor of intimate partner violence (IPV) perpetration for young adult men and women; therefore, interventions delivered proximally to drinking episodes - a period of high risk - are needed to reduce alcohol-facilitated IPV. This project seeks to improve public health by delivering a just-in-time text messaging intervention proximally to drinking episodes and evaluating the impact of the intervention on alcohol-facilitated IPV in a sample of at-risk young adult men and women. Additionally, through an innovative design this project is poised to answer these important questions: whether receiving a message, when, for whom, what type, and under what conditions this just-in-time messaging intervention leads to reductions in alcohol use and IPV perpetration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 years old\n* Consumed alcohol an average of 2 times per week in last 3 months\n* At least two instances of heavy episodic drinking in last month\n* Currently in a romantic relationship\n* History of IPV perpetration within last 3 months\n* Willing to provide cell phone number and carrier and receive text messages for 30 days\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05145868', 'briefTitle': 'Just-In-Time Intervention to Reduce Alcohol-Facilitated Intimate Partner Violence Perpetration', 'organization': {'class': 'OTHER', 'fullName': 'Georgia State University'}, 'officialTitle': 'Evaluation and Optimization of a Just-in-Time Messaging Intervention to Reduce Alcohol-Facilitated Intimate Partner Violence Perpetration Among At-Risk Young Adult Men and Women', 'orgStudyIdInfo': {'id': 'SP00014947'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants in this arm will receive the RELATE intervention.', 'interventionNames': ['Behavioral: Alcohol Skills and Emotion Regulation Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control', 'description': 'Participants in this arm will receive supportive control messages.', 'interventionNames': ['Other: Attention Control']}], 'interventions': [{'name': 'Alcohol Skills and Emotion Regulation Intervention', 'type': 'BEHAVIORAL', 'description': 'The text-based intervention will provide alcohol reduction strategies and emotion regulation skills.', 'armGroupLabels': ['Intervention']}, {'name': 'Attention Control', 'type': 'OTHER', 'description': 'Text-messages will be sent that include no intervention content to serve as an attention control', 'armGroupLabels': ['Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shaniah Williams, BA', 'role': 'CONTACT', 'email': 'projectRELATE@gsu.edu', 'phone': '404-413-6224'}], 'facility': 'Georgia State University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Cynthia Stappenbeck, PhD', 'role': 'CONTACT', 'email': 'cstappenbeck@gsu.edu', 'phone': '404-413-6321'}], 'overallOfficials': [{'name': 'Cynthia Stappenbeck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgia State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cynthia Stappenbeck', 'investigatorAffiliation': 'Georgia State University'}}}}