Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-02 @ 12:03 PM
Study NCT ID:
NCT00183157
Status:
UNKNOWN
Last Update Posted:
2009-02-13
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project RAP: Reaching Adolescents for Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'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': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in drinking', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Reduction in alcohol associated health consequences', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['High risk drinking', 'Alcohol dependence', 'Alcohol related injury'], 'conditions': ['Alcohol Related Morbidity', 'Alcohol Dependence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://sph.bu.edu/index.php?option=com_content&task=view&id=412&Itemid=515', 'label': 'Reaching Adolescents for Prevention (RAP), Boston University School of Public Health'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if a brief motivational interview in the context of an emergency health care visit will reduce high-risk drinking and drug-taking and associated health consequences among adolescents ages 14-21 years old.', 'detailedDescription': 'Many studies have shown that a brief motivational interview in the context of a routine or emergency health care visit may assist adults to reduce high-risk drinking and drug-taking. Center researchers are conducting a 1,400-person, randomized clinical trial involving teen patients at the Boston Medical Center Pediatric Emergency Department in order to determine if a similar approach will be effective with youth. All patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. One-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. One-third will receive only the assessment and a list of community resources; and the final third will receive only the list of resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric emergency department patients\n* Aged 14-21\n* An Alcohol Use Disorders Identification Test (AUDIT) score above selected cut-point for age or with history of alcohol-related consequences\n\nExclusion Criteria:\n\n* Not resident in area or able to provide contact information for 12 month follow-up\n* Medically unstable\n* Not oriented to person, time and place'}, 'identificationModule': {'nctId': 'NCT00183157', 'briefTitle': 'Project RAP: Reaching Adolescents for Prevention', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)'}, 'officialTitle': 'RAP: Reaching Adolescents for Prevention - A Randomized Trial of a Brief Negotiated Interview and Active Referral to Reduce Alcohol Related Morbidity Among Youth and Young Adults in the Pediatric Emergency Department', 'orgStudyIdInfo': {'id': 'NIAAABER13759'}, 'secondaryIdInfos': [{'id': 'NIH 5P60 AA13759'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Patients will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call.', 'interventionNames': ['Behavioral: Brief Motivational Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Patients will receive an assessment and a list of community resources', 'interventionNames': ['Behavioral: Assessment and list of resources']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Patients will receive only the list of resources.', 'interventionNames': ['Behavioral: Referral to Community Resources']}], 'interventions': [{'name': 'Brief Motivational Intervention', 'type': 'BEHAVIORAL', 'description': 'One-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.', 'armGroupLabels': ['1']}, {'name': 'Assessment and list of resources', 'type': 'BEHAVIORAL', 'description': 'One-third will receive only the assessment and a list of community resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.', 'armGroupLabels': ['2']}, {'name': 'Referral to Community Resources', 'type': 'BEHAVIORAL', 'description': 'All patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. One-third of the enrollees will receive only a list of resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Cole', 'role': 'CONTACT', 'email': 'barbcole@bu.edu', 'phone': '617-638-4600'}, {'name': 'Edward Bernstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Judith Bernstein, RNC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Dorfman, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Boston Medical Center Pediatric Emergency Department', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Cole', 'role': 'CONTACT', 'email': 'barbcole@bu.edu', 'phone': '617-638-4600'}, {'name': 'David Rosenbloom, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Boston University School of Public Health - Youth Alcohol Prevention Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Barbara Cole', 'role': 'CONTACT', 'email': 'barbcole@bu.edu', 'phone': '617-638-4600'}], 'overallOfficials': [{'name': 'Edward Bernstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University School of Public Health - Youth Alcohol Prevention Center'}, {'name': 'Judith Bernstein, RNC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University School of Public Health - Youth Alcohol Prevention Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Edward Bernstein, MD/Judith Bernstein, RNC, PhD', 'oldOrganization': 'Boston University School of Public Health - Youth Alcohol Prevention Center'}}}}