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Completed

NCT Number: NCT01825694

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Traumatic Stress

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behavioral Health Services

Los Angeles, California, 90032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Timeline Follow-back (TFLB) Assessment of Substance Use

    Time frame: Participants will be followed for an expected average of 12 weeks.

    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.

  2. Urine Toxicology Screen (UTS)

    Time frame: Participants will be followed for an expected average of 12 weeks.

    Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports.

  3. Child PTSD Symptom Scale (CPSS)

    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.

    The CPSS will assess for severity of traumatic stress symptoms.

Secondary outcomes

  1. Child Post-Trauma Attitudes Scale (C-PTAS)

    Time frame: Baseline & 8 weeks & 3 months

    The C-PTAS will be used to assess trauma-related attitudes and beliefs.

  2. Strengths & Difficulties Questionnaire (SDQ)

    Time frame: Baseline & 8 weeks & 3 months

    The SDQ will be used to assess parent-report of behavioral problems.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2013
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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