An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Substance Abuse; Traumatic Stress
• Intervention / Treatment: Behavioral: Trauma-focused Substance Abuse Intervention

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90032
      • Behavioral Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; 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.
Experimental: Trauma-focused Substance Abuse Intervention; See Intervention Arm description.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Strengths & Difficulties Questionnaire (SDQ)	The SDQ will be used to assess parent-report of behavioral problems.	Baseline & 8 weeks & 3 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Nancy S Wu, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimated): April 8, 2013

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Substance Abuse; Traumatic Stress
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1R34DA031301 (U.S. NIH Grant/Contract)