An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

Conditions
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Substance Abuse, Traumatic Stress

Intervention / Treatment
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* Behavioral: Trauma-focused Substance Abuse Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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<br>See Intervention Arm description. | Behavioral: Trauma-focused Substance Abuse Intervention<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance Abuse, Traumatic Stress