Evaluation of RRFT for Co-occurring SUD and PTSD Among Teens

NCT ID: NCT05384223

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2026-06-30

Brief Summary

Psychosocial traumatic events during childhood, serve as strong and consistent predictors of substance use problems (SUP) during adolescence and adulthood.PTSD that extends from such trauma often co-occurs with SUP. Despite this well-established link, standard care for adolescents with co-occurring SUP and PTSD for the last several decades has been to treat these problems separately. This compartmentalized approach to treatment creates a burden on teens and families, raises unique challenges to clinicians in both mental health and addiction domains, and may contribute to high rates of SUP relapse among adolescents with co-occurring PTSD. To address this problem, our team recently completed a rigorous National Institute on Drug Abuse (NIDA)-funded randomized controlled trial (RCT) supporting the efficacy of an integrative, exposure-based treatment we developed, Risk Reduction through Family Therapy (RRFT), in greater long term reductions in SUP, as well as PTSD avoidance and hyperarousal symptoms, in comparison to standard treatment in a large teen sample. The proposed RCT, with an effectiveness-implementation Hybrid Type I design, substantially builds on that prior research by proposing to 1) evaluate whether RRFT's clinical effectiveness for reducing SUP and PTSD can be extended to youth in outpatient substance use treatment settings-where youth are presenting for SUP treatment and where clinicians often have less experience treating PTSD (Aim 1); 2)evaluate the cost-effectiveness of RRFT and to explore inner context variables (e.g., perceived treatment acceptability, attitudes, and satisfaction among the participating adolescents, caregivers, agency leaders, and therapists and barriers to and facilitators of implementation) that might affect RRFT implementation in diverse practice settings(Aim 2). The proposed effectiveness-implementation trial will recruit adolescents (13-18 years) with a history of psychosocial trauma presenting with SUP and PTSD symptoms for outpatient substance use disorder treatment at sites in Denver, Colorado. Participants will be randomized to RRFT or Treatment as Usual. A multi-method, multi-respondent approach will track clinical outcomes(SUP, PTSD, and putative targets of treatment, such as emotional suppression)at 3, 6, and 12 months post-baseline.

Conditions

Substance Use Disorders; PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RRFT (Risk Reduction through Family Therapy)

Group Type: EXPERIMENTAL

RRFT (Risk Reduction through Family Therapy)

Intervention Type: BEHAVIORAL

RRFT is an adaptation and integration of existing empirically-supported interventions with similar theoretical rationales targeting similar populations, particularly Multisystemic Therapy principles (MST)for adolescent SUP and Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) components for PTSD in youth. RRFT consists of seven primary components: Psychoeducation and Engagement, Coping, Family Communication, Substance Use, PTSD, Healthy Dating and Sexual Decision-Making, and Revictimization Risk Reduction.

Treatment as Usual (TAU): Encompass

Group Type: ACTIVE_COMPARATOR

ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)

Intervention Type: BEHAVIORAL

Encompass is currently a research to practice treatment for adolescents with co-occurring substance use disorders and mental health problems and is used as the standard treatment in the target study settings.

Interventions

RRFT (Risk Reduction through Family Therapy)

RRFT is an adaptation and integration of existing empirically-supported interventions with similar theoretical rationales targeting similar populations, particularly Multisystemic Therapy principles (MST)for adolescent SUP and Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) components for PTSD in youth. RRFT consists of seven primary components: Psychoeducation and Engagement, Coping, Family Communication, Substance Use, PTSD, Healthy Dating and Sexual Decision-Making, and Revictimization Risk Reduction.

Intervention Type: BEHAVIORAL

ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)

Encompass is currently a research to practice treatment for adolescents with co-occurring substance use disorders and mental health problems and is used as the standard treatment in the target study settings.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Aged 13-19 years (adolescents);

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

Oregon Social Learning Center

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Carla Kmett Danielson

Dr. Carla Kmett Danielson, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla Kmett Danielson, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Paula Riggs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

CU Medicine Psychiatry - Outpatient Clinic

Aurora, Colorado, United States

Site Status: RECRUITING

ARTS - Synergy Outpatient Services

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deidre Bellmore, BA

Role: CONTACT

startrial@cuanschutz.edu

303.724.6956

Paula Riggs, PhD

Role: CONTACT

paula.riggs@cuanschutz.edu

Facility Contacts

Deidre Bellmore, BA

Role: primary

startrial@cuanschutz.edu

303.724.6956

Deidre Bellmore, BA

Role: primary

startrial@cuanschutz.edu

303.724.6956

Other Identifiers

Pro00113543

Identifier Type: -

Identifier Source: org_study_id