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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2023
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
Trauma-focused Substance Abuse Intervention
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.

Locations

Country Name City State
United States Behavioral Health Services Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

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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