An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

NCT01825694 | Completed

• 1 other identifier: 1R34DA031301
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Abuse; Traumatic Stress

Keywords

Substance Abuse; Traumatic Stress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Child Post-Trauma Attitudes Scale (C-PTAS)

  Baseline & 8 weeks & 3 months

• Strengths & Difficulties Questionnaire (SDQ)

  Baseline & 8 weeks & 3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Trauma-focused Substance Abuse Intervention

EXPERIMENTAL

See Intervention Arm description.

Behavioral: Trauma-focused Substance Abuse Intervention

Interventions

Trauma-focused Substance Abuse Intervention BEHAVIORAL

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.

Trauma-focused Substance Abuse Intervention

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not within the specified age range;
• presence of organic brain damage;
• inability to understand enrollment forms (e.g. Informed Assent/Consent Form)
• Age 18 or above;
• presence of organic brain damage.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Behavioral Health Services

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Nancy S Wu, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: April 8, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

US (1)