An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

Substance Abuse Clinical Trial

Official title:

An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825694
• Other study ID #: 1R34DA031301
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders
• Traumatic Stress

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