Substance Abuse Clinical Trial
Official title:
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
NCT number | NCT01825694 |
Other study ID # | 1R34DA031301 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | May 2015 |
Verified date | September 2023 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. The investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.
Status | Completed |
Enrollment | 117 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 19 Years |
Eligibility | Inclusion Criteria: Youth - Between ages of 13 & 19; - meeting DSM IV criteria for substance abuse/dependence and PTSD; - previously enrolled at recruitment site for at least 2 weeks; - parent/guardian provides permission for minors to participate. Exclusion Criteria: Youth - Not within the specified age range; - presence of organic brain damage; - inability to understand enrollment forms (e.g. Informed Assent/Consent Form) Inclusion Criteria: Parents/Guardians - Age 18 or above; - parents/guardians of youth who meets inclusion criteria. Exclusion Criteria: Parents/Guardians - presence of organic brain damage. |
Country | Name | City | State |
---|---|---|---|
United States | Behavioral Health Services | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Timeline Follow-back (TFLB) Assessment of Substance Use | 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. | Participants will be followed for an expected average of 12 weeks. | |
Primary | Urine Toxicology Screen (UTS) | Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports. | Participants will be followed for an expected average of 12 weeks. | |
Primary | Child PTSD Symptom Scale (CPSS) | The CPSS will assess for severity of traumatic stress symptoms. | Change from Baseline in Child PTSD Symptom Scale at 8 weeks and change from Baseline in Child PTSD Symptom Scale at 12 weeks. | |
Secondary | Child Post-Trauma Attitudes Scale (C-PTAS) | The C-PTAS will be used to assess trauma-related attitudes and beliefs. | Baseline & 8 weeks & 3 months | |
Secondary | Strengths & Difficulties Questionnaire (SDQ) | The SDQ will be used to assess parent-report of behavioral problems. | Baseline & 8 weeks & 3 months |
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