Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT03401333
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2018-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A brief motivational interview and four weeks of text messaging.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2018-01-16', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment', 'timeFrame': 'Baseline', 'description': 'Number of participants per month that enroll in the study'}, {'measure': 'Retention', 'timeFrame': '4 weeks', 'description': '% of enrolled participants that complete the 4-week follow up assessments'}, {'measure': 'Satisfaction', 'timeFrame': '4 weeks', 'description': "Participant's rating of how much they like the intervention (Likert scale)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking', 'Marijuana']}, 'descriptionModule': {'briefSummary': 'This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use that adds a 4-week course of tailored text messaging to a brief motivational intervention for 13-18-year-old adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 13 to 18 years old\n* Able to provide consent or assent and parental permission\n* have a functioning cell phone without pay-as-you-go text messaging\n\nExclusion Criteria:\n\n* currently enrolled in any substance abuse program;\n* have medical/psychiatric condition that precludes participation'}, 'identificationModule': {'nctId': 'NCT03401333', 'acronym': 'STAR', 'briefTitle': 'Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Feasibility of Augmenting Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use', 'orgStudyIdInfo': {'id': '2000021254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text messaging and brief intervention', 'description': 'Brief motivational interview and 4-weeks of text messaging.', 'interventionNames': ['Behavioral: Text Messaging and Brief Negotiation Interview']}], 'interventions': [{'name': 'Text Messaging and Brief Negotiation Interview', 'type': 'BEHAVIORAL', 'description': 'An in-person brief motivational intervention coupled with 4 weeks of motivational text messages', 'armGroupLabels': ['Text messaging and brief intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}