Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-08 @ 12:34 AM
Study NCT ID:
NCT00593034
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Office Intervention for Adolescent Drug Use - Attention Study Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-07', 'studyFirstSubmitDate': '2008-01-03', 'studyFirstSubmitQcDate': '2008-01-03', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on the Connors Continuous Performance Test II (CCPT II)', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Percentage of days abstinent', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alcohol abuse', 'Drug abuse'], 'conditions': ['Substance-related Disorders']}, 'referencesModule': {'references': [{'pmid': '10357299', 'type': 'BACKGROUND', 'citation': 'Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6. doi: 10.1001/archpedi.153.6.591.'}, {'pmid': '12038895', 'type': 'BACKGROUND', 'citation': 'Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.'}], 'seeAlsoLinks': [{'url': 'http://www.ceasar.org', 'label': 'Web site for the Center for Adolescent Substance Abuse Research, parent research group for the project.'}]}, 'descriptionModule': {'briefSummary': 'This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a randomized controlled trial of a brief behavioral treatment for substance abuse.\n\nThis study will describe at baseline levels of attention using a well validated instrument (Connors Continuous Performance Test II) and explore the association between attention levels and substance use. The primary study hypothesis is that lower initial levels of substance use (as measured by percent days abstinent) will be associated with higher attention levels. We envision that this data will inform a better understanding of how attention may modify treatment response.', 'detailedDescription': 'Research among adolescents with substance use problems presents unique challenges to investigators. Issues with recruitment, confidentiality, and follow-up have been cited as common limitations to research in this area. One likely contributor to decreased treatment persistence and follow-up is the limited ability to sustain attention that many adolescents, especially those with substance problems, may manifest. (Taper, 2002) Thus, assessing attention before beginning substance abuse treatment has the potential not only to inform the science of adolescent addiction medicine, but also to guide the development of therapies to specifically address attention deficits among adolescent substance users. Adolescent outpatients being treated for substance problems have not been systematically studied for clinical or subclinical attention levels.\n\nThe primary aims this study are as follows:\n\n1. To test the feasibility of administering the Connors Continuous Performance Test II (CCPT II), a well validated measure of attention, to a sample of 12-21 year old patients receiving treatment for substance abuse.\n2. To obtain baseline descriptive statistics on the CCPT II in a previously understudied group of young patients receiving treatment for substance abuse.\n3. To estimate the magnitude of the association between substance use and levels of attention at baseline before treatment.\n4. To explore the degree to which attention may affect response to substance abuse treatment in general and specifically motivational interviewing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse."', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CRAFFT score of 1 or more\n* Have used cannabis, alcohol or another drug on at least two occasions during the 30 days preceding their visit\n* Can read and understand English\n\nExclusion Criteria:\n\n* Require immediate hospitalization or referral to residential substance abuse treatment\n* Will not be available to complete the study assessments over the next 9 months.'}, 'identificationModule': {'nctId': 'NCT00593034', 'briefTitle': 'Medical Office Intervention for Adolescent Drug Use - Attention Study Supplement', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Medical Office Intervention for Adolescent Drug Use - Research Supplement for Under-represented Minorities', 'orgStudyIdInfo': {'id': 'R01DA014553-03S1', 'link': 'https://reporter.nih.gov/quickSearch/R01DA014553-03S1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Participants in this study will be 12-21 year old patients who have been referred to the Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse."'}]}, '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': {'oldNameTitle': 'John R. Knight, MD', 'oldOrganization': "Children's Hospital Boston"}}}}