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An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

Primary Purpose

Substance Abuse, Traumatic Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-focused Substance Abuse Intervention
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance Abuse, Traumatic Stress

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Behavioral Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Trauma-focused Substance Abuse Intervention

Arm Description

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.

See Intervention Arm description.

Outcomes

Primary Outcome Measures

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.
Urine Toxicology Screen (UTS)
Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports.
Child PTSD Symptom Scale (CPSS)
The CPSS will assess for severity of traumatic stress symptoms.

Secondary Outcome Measures

Child Post-Trauma Attitudes Scale (C-PTAS)
The C-PTAS will be used to assess trauma-related attitudes and beliefs.
Strengths & Difficulties Questionnaire (SDQ)
The SDQ will be used to assess parent-report of behavioral problems.

Full Information

First Posted
July 18, 2012
Last Updated
September 27, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01825694
Brief Title
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
Official Title
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Traumatic Stress
Keywords
Substance Abuse, Traumatic Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Trauma-focused Substance Abuse Intervention
Arm Type
Experimental
Arm Description
See Intervention Arm description.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-focused Substance Abuse Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timeline Follow-back (TFLB) Assessment of Substance Use
Description
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.
Time Frame
Participants will be followed for an expected average of 12 weeks.
Title
Urine Toxicology Screen (UTS)
Description
Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports.
Time Frame
Participants will be followed for an expected average of 12 weeks.
Title
Child PTSD Symptom Scale (CPSS)
Description
The CPSS will assess for severity of traumatic stress symptoms.
Time Frame
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 Measure Information:
Title
Child Post-Trauma Attitudes Scale (C-PTAS)
Description
The C-PTAS will be used to assess trauma-related attitudes and beliefs.
Time Frame
Baseline & 8 weeks & 3 months
Title
Strengths & Difficulties Questionnaire (SDQ)
Description
The SDQ will be used to assess parent-report of behavioral problems.
Time Frame
Baseline & 8 weeks & 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy S Wu, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Health Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States

12. IPD Sharing Statement

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An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

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