Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT01454206
Status:
WITHDRAWN
Last Update Posted:
2016-10-07
First Post:
2011-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The project was not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2011-10-05', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provider attitude toward iSBIRT', 'timeFrame': '12 months post baseline', 'description': "We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices."}], 'secondaryOutcomes': [{'measure': 'Youth connectedness to provider', 'timeFrame': 'Baseline', 'description': "We will measure adolescents' attitudes toward their providers' advice regarding the health effects of substance use given during the visit"}, {'measure': 'iSBIRT sustainability', 'timeFrame': '12 months post', 'description': 'We will measure rates of continued use of iSBIRT by practices 12 months after iSBIRT recruitment and implementation ends'}, {'measure': 'Change in rates of adolescent substance use', 'timeFrame': '3 months post baseline', 'description': 'We will measure the change in rates of adolescent substance use from baseline to 3 months post study visit.'}, {'measure': 'Change in rates of adolescent substance use', 'timeFrame': '6 months post baseline', 'description': 'We will measure the change in rates of adolescent substance use from baseline to 6 months post study visit.'}, {'measure': 'Change in rates of adolescent substance use', 'timeFrame': '12 months post baseline', 'description': 'We will measure the change in rates of adolescent substance use from baseline to 12 months post study visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cannabis abuse', 'alcohol abuse', 'substance abuse'], 'conditions': ['Substance Use']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ceasar.org', 'label': "Center for Adolescent Substance Abuse Research at Children's Hospital Boston"}]}, 'descriptionModule': {'briefSummary': "The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12-18 year olds\n* Coming for non-emergent care\n* Access to a private computer\n* Have email address\n\nExclusion Criteria:\n\n* Not available for follow-up questionnaires\n* Unable to read or understand English at a 6th grade reading level\n* Medically or emotionally unstable on the day of the visit'}, 'identificationModule': {'nctId': 'NCT01454206', 'briefTitle': 'Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Integration of Internet-facilitated Screening, Brief Intervention, Referral to Treatment (iSBIRT) for Teen Drug Use Into a Pediatric Network', 'orgStudyIdInfo': {'id': 'CeASAR app RFADA12008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual'}, {'type': 'EXPERIMENTAL', 'label': 'iSBIRT', 'description': 'Participants will receive the internet-facilitated screening, brief intervention and referral to treatment (iSBIRT intervention)', 'interventionNames': ['Behavioral: iSBIRT']}], 'interventions': [{'name': 'iSBIRT', 'type': 'BEHAVIORAL', 'description': 'Participants will be screened for substance use, view information about the health effects of substance use on the computer, and receive advice from the primary care provider regarding the health effects of substance use. Those found to be at "high risk" will complete an internet-based program encouraging them to change their substance use.', 'armGroupLabels': ['iSBIRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'John R Knight, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital", 'investigatorFullName': 'John R Knight, MD', 'investigatorAffiliation': "Boston Children's Hospital"}}}}