Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-12 @ 1:49 AM
Study NCT ID:
NCT01825694
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2012-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2012-07-18', 'studyFirstSubmitQcDate': '2013-04-01', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timeline Follow-back (TFLB) Assessment of Substance Use', 'timeFrame': 'Participants will be followed for an expected average of 12 weeks.', 'description': 'The TLFB uses a blank calendar form and a series of questions to cue recall of alcohol and drug (AOD) use. The investigators will use the TLFB interview technique to assess AOD use weekly.'}, {'measure': 'Urine Toxicology Screen (UTS)', 'timeFrame': 'Participants will be followed for an expected average of 12 weeks.', 'description': 'Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports.'}, {'measure': 'Child PTSD Symptom Scale (CPSS)', 'timeFrame': 'Change from Baseline in Child PTSD Symptom Scale at 8 weeks and change from Baseline in Child PTSD Symptom Scale at 12 weeks.', 'description': 'The CPSS will assess for severity of traumatic stress symptoms.'}], 'secondaryOutcomes': [{'measure': 'Child Post-Trauma Attitudes Scale (C-PTAS)', 'timeFrame': 'Baseline & 8 weeks & 3 months', 'description': 'The C-PTAS will be used to assess trauma-related attitudes and beliefs.'}, {'measure': 'Strengths & Difficulties Questionnaire (SDQ)', 'timeFrame': 'Baseline & 8 weeks & 3 months', 'description': 'The SDQ will be used to assess parent-report of behavioral problems.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Substance Abuse', 'Traumatic Stress'], 'conditions': ['Substance Abuse', 'Traumatic Stress']}, 'descriptionModule': {'briefSummary': 'This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care.\n\nThe investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Youth\n\n* Between ages of 13 \\& 19;\n* meeting DSM IV criteria for substance abuse/dependence and PTSD;\n* previously enrolled at recruitment site for at least 2 weeks;\n* parent/guardian provides permission for minors to participate.\n\nExclusion Criteria: Youth\n\n* Not within the specified age range;\n* presence of organic brain damage;\n* inability to understand enrollment forms (e.g. Informed Assent/Consent Form)\n\nInclusion Criteria: Parents/Guardians\n\n* Age 18 or above;\n* parents/guardians of youth who meets inclusion criteria.\n\nExclusion Criteria: Parents/Guardians\n\n* presence of organic brain damage.'}, 'identificationModule': {'nctId': 'NCT01825694', 'briefTitle': 'An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents', 'orgStudyIdInfo': {'id': '1R34DA031301', 'link': 'https://reporter.nih.gov/quickSearch/1R34DA031301', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'The Standard of Care condition includes: 1) an individual session with the counselor, once per week; 2) a treatment group with the counselor, twice per week; and 3) parents of youth are invited to attend parent-only educational sessions weekly.'}, {'type': 'EXPERIMENTAL', 'label': 'Trauma-focused Substance Abuse Intervention', 'description': 'See Intervention Arm description.', 'interventionNames': ['Behavioral: Trauma-focused Substance Abuse Intervention']}], 'interventions': [{'name': 'Trauma-focused Substance Abuse Intervention', 'type': 'BEHAVIORAL', 'description': 'An integrated treatment approach to reduce substance use and PTSD symptoms. The intervention program includes: 1) 1-2 individual sessions during which youth talk about the trauma, during the course of the intervention program; 2) 16 group sessions for youth; 3) 2 conjoint sessions with parents to improve communication and problem-solving skills; and 4) 2 parent-education group sessions.', 'armGroupLabels': ['Trauma-focused Substance Abuse Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90032', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Behavioral Health Services', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Nancy S Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}