Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT01667159
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2012-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Based Integrated Treatment for Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004327', 'term': 'Drinking Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-21', 'studyFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Measured at 18 months from baseline'}], 'secondaryOutcomes': [{'measure': 'Alcohol/Substance Use', 'timeFrame': 'Measured at 18 months from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'Alcohol Use', 'Outpatient Therapy'], 'conditions': ['Depression', 'Alcohol Use']}, 'referencesModule': {'references': [{'pmid': '34238628', 'type': 'DERIVED', 'citation': 'Spirito A, Nestor B, Massing-Schaffer M, Esposito-Smythers C, Stout R, Frazier E, Gomez J, Graves H, Yen S, Hunt J, Wolff J. Predictors and moderators of marijuana and heavy alcohol use outcomes in adolescents treated for co-occurring substance use and psychiatric disorders in a randomized controlled trial. J Subst Abuse Treat. 2021 Dec;131:108536. doi: 10.1016/j.jsat.2021.108536. Epub 2021 Jun 15.'}, {'pmid': '33607509', 'type': 'DERIVED', 'citation': 'MacPherson HA, Wolff J, Nestor B, Frazier E, Massing-Schaffer M, Graves H, Esposito-Smythers C, Spirito A. Parental Monitoring Predicts Depressive Symptom and Suicidal Ideation Outcomes in Adolescents Being Treated for Co-Occurring Substance Use and Psychiatric Disorders. J Affect Disord. 2021 Apr 1;284:190-198. doi: 10.1016/j.jad.2021.02.021. Epub 2021 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community.', 'detailedDescription': "Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders are related in adolescence. For example, in a community sample, teens who reported a history of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD) than teens with no history of AUD. The scientific community has only recently begun to examine how to treat adolescents with both AUD and MDD. Reviews have concluded that depression negatively affects treatment for substance abuse. At the same time, substance use issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that protocols are needed to specifically address substance abusing, depressed adolescents. This study is designed to determine if an integrated (CBT-I) protocol designed to treat both substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and CBT-SC conditions will be delivered by licensed mental health workers at a community mental health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4 years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by reporting both depressed mood and substance abuse, these eligible families will complete a thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The baseline battery will be repeated at the end of treatment, and 6 and 12 months after treatment completion to determine how families in the study do over time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking adolescent and parent\n* Current substance use disorder\n* Co-occurring psychiatric symptomatology\n\nExclusion Criteria:\n\n* IQ \\< 80\n* Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa\n* Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days'}, 'identificationModule': {'nctId': 'NCT01667159', 'briefTitle': 'Community-Based Integrated Treatment for Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Adolescents With Major Depression and AUD: Community-Based Integrated Treatment', 'orgStudyIdInfo': {'id': '1R01AA020705-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA020705-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01AA020705-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA020705-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated Cognitive Behavioral Therapy', 'description': 'Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.', 'interventionNames': ['Behavioral: Integrated Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.', 'interventionNames': ['Behavioral: Standard Care']}], 'interventions': [{'name': 'Integrated Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT for adolescents and parents'], 'description': 'Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.', 'armGroupLabels': ['Integrated Cognitive Behavioral Therapy']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'otherNames': ['Intensive Outpatient Therapy', 'Treatment As Usual (TAU)'], 'description': 'Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Anthony Spirito, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anthony Spirito', 'investigatorAffiliation': 'Brown University'}}}}