Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT01544218
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2012-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validating NIAAA Screen Guide in YCMC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 521}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eGuide diagnosis of alcohol use disorder', 'timeFrame': 'Baseline', 'description': 'We will evaluate the sensitivity and specificity of the eGuide to correctly identify the group of YCMC who have problem use/abuse or dependence, using the CIDI-SAM as the criterion standard.'}], 'secondaryOutcomes': [{'measure': 'Correlation of HgbA1c level with level of alcohol use', 'timeFrame': 'Baseline'}, {'measure': 'Correlation between score on the Asthma Control Test (ACT)and level of alcohol use', 'timeFrame': 'Baseline'}, {'measure': 'Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use', 'timeFrame': 'baseline'}, {'measure': 'Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol related disorders'], 'conditions': ['Alcohol Related Disorders']}, 'descriptionModule': {'briefSummary': 'Alcohol use is a serious health threat to the 26% youth in the US with chronic medical conditions. While alcohol use can significantly impact an underlying illness and its safe/effective management, medical specialists rarely screen their adolescent patients for alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18 year old youth with chronic medical conditions. Comprehensive assessment information will be collected and analyzed to describe relationships between youth alcohol use, other substance use, and chronic disease outcomes and findings integrated into the validated screen as actionable clinician guidance and health advice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 9-18 years of age\n* duration of chronic illness of at least one year\n* ability to speak/read English and use a computer keyboard and/or complete an interviewer-assisted questionnaire\n\nExclusion Criteria:\n\n* medically or emotionally unstable\n* unable to assent/consent'}, 'identificationModule': {'nctId': 'NCT01544218', 'briefTitle': 'Validating NIAAA Screen Guide in YCMC', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': "Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions", 'orgStudyIdInfo': {'id': 'SL_NIAAARFA_0212'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'YCMC', 'description': 'Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions'}]}, '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': 'Sharon Levy, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Elissa Weitzman, ScD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics, Harvard Medical School', 'investigatorFullName': 'Sharon Levy', 'investigatorAffiliation': "Boston Children's Hospital"}}}}