Treatment for teens with substance use disorders and PTSD

Evaluation of Clinical Effectiveness, Cost, and Implementation Factors to Optimize Scalability of Treatment for Co-occurring SUD and PTSD Among Teens

This study is testing a new family therapy approach to help teenagers aged 13-19 who are struggling with both substance use and PTSD to see if it can improve their symptoms together.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 212 (estimated)
• Ages: 13 Years to 19 Years
• Sex: All
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 2 sites (Aurora, Colorado and 1 other locations)
• Trial ID: NCT05384223 on ClinicalTrials.gov

What this trial studies

This study evaluates an integrative treatment approach called Risk Reduction through Family Therapy (RRFT) for adolescents aged 13-19 who are experiencing co-occurring substance use disorders (SUD) and post-traumatic stress disorder (PTSD). The study aims to address the challenges of treating these conditions separately, which can lead to high relapse rates. By utilizing a family therapy model, the intervention seeks to reduce symptoms of both SUD and PTSD simultaneously. The effectiveness of RRFT is being assessed through a randomized controlled trial framework.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 13-19 who have experienced traumatic events and exhibit symptoms of PTSD along with substance use.

Not a fit: Patients who do not have a history of trauma or do not meet the criteria for PTSD or substance use may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for adolescents struggling with both substance use and PTSD.

How similar studies have performed: Previous studies have shown promise in integrated treatment approaches for co-occurring disorders, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Aged 13-19 years;
2. Experienced lifetime DSM-V PTSD Criteria A-defined potentially traumatic event, such as interpersonal violence, with memory of incident(s), such as child sexual abuse (forced or unwanted vaginal or anal penetration by an object, finger, or penis; oral sex; touching of the respondent's breasts or genitalia; or respondents' touching of another person's genitalia); child physical abuse (nonaccidental physical injury to the child or any action that results in a physical impairment of the child), witnessed domestic violence (exposure to conduct by a household member against another household member that involves attempted or completed assault or murder); witnessed community violence; dating violence; as well as disasters, accidents, etc.;
3. Five or more current DSM-V PTSD symptoms as assessed on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)/UCLA PTSD Index;
4. Substance use, defined as alcohol or non-tobacco drug use, in the past 28 days prior to study screening per self-report. If in a restrictive setting for the 28 days prior to study screening, substance use will be anchored to use prior to entering restrictive setting;
5. A current (past year) non-nicotine substance use disorder (SUD) as assessed on the K-SADS;
6. English-speaking.

Exclusion Criteria:

1. Presence of Pervasive Developmental Disability or Moderate/Severe Mental Retardation or other cognitive limitation that would preclude meaningful engagement in RRFT or cognitive-behavioral therapy
2. Actively suicidal/homicidal;
3. Active psychosis.

Where this trial is running

Aurora, Colorado and 1 other locations

• CU Medicine Psychiatry - Outpatient Clinic — Aurora, Colorado, United States (Recruiting)
• ARTS - Synergy Outpatient Services — Denver, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Carla Kmett Danielson, PhD — Medical University of South Carolina
• Study coordinator: Deidre Bellmore, BA

Conditions Substance Use Disorders; PTSD; Treatment; Adolescent Substance Use