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

NCT05384223 | Active Not Recruiting DMC

• 1 other identifier: Pro00113543
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

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

Keywords

Treatment; Adolescent Substance Use; PTSD

Outcome Measures

Primary Outcomes (2)

• Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 12 months.

  The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.

  Collected at baseline, 3, 6, & 12 months

• UCLA PTSD Index DSM V - Change from baseline in UCLA PTSD total score @ 3,6, and 12 months

  The University of California, Los Angeles (UCLA) Post Traumatic Stress Disorder Index Diagnostic and Statistical Manuals 4th ed (DSM-IV; UCLA PTSD Index DSM-IV) is a validated, subjective measure that consists of 23 yes or no questions regarding the occurrence of different traumas or losses that may happen during a child's life. Each question is followed up with details of the trauma that occurred and more extensive questioning for the trauma experienced that is still most bothersome in the present day. These follow-up questions gauge symptoms of PTSD on a five-point Likert scale that ranges from "none" (score of 0, no days has this symptom occurred in the last month) to "most" (score of 4, symptom occurred almost every day in the past month). The most traumatic experience is also followed by several yes/no questions that gauge distress and functional impairment. Higher scores are indicative of higher rates of PTSD symptoms.

  Collected at baseline, 3, 6, & 12 months

Secondary Outcomes (6)

• Urine Drug Screen (UDS) - Between group comparison -total # negative UDS /total # collected at baseline, 3, 6, & 12 months

  Collected at baseline, 3, 6, & 12 months

• Timeline Follow Back (TFLB) - total # of days/28 day of cannabis use, alcohol use, and other non-nicotine substance use (excluding cannabis, alcohol).

  Collected at baseline, 3, 6, & 12 months

• Response to Stress Questionnaire (RSQ) - Change from baseline in Adolescent/Child's Self-Report Responses to Family Stressors (subscale score items a-l)

  Change from baseline @ 3,6, and 12 months

• Alabama Parenting Questionnaire (APQ) - positive parenting subscale, inconsistent discipline subscale, and supervision/monitoring subscale.

  Collected at baseline, 3, 6, & 12 months

• Difficulties in Emotion Regulation Scale (DERS) - Change from baseline in total score @ 3, 6, & 12 mo f/u

  Change from baseline in total score @ 3, 6, & 12 month follow-up

Study Arms (2)

RRFT (Risk Reduction through Family Therapy)

EXPERIMENTAL

Behavioral: RRFT (Risk Reduction through Family Therapy)

Treatment as Usual (TAU): Encompass

ACTIVE COMPARATOR

Behavioral: ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)

Interventions

ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) 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.

Treatment as Usual (TAU): Encompass

RRFT (Risk Reduction through Family Therapy) 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.

RRFT (Risk Reduction through Family Therapy)

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 13-19 years (adolescents);
• 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.;
• Five or more current DSM-V PTSD symptoms as assessed on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)/UCLA PTSD Index;
• 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;
• A current (past year) non-nicotine substance use disorder (SUD) as assessed on the K-SADS;
• English-speaking.

You may not qualify if:

• 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
• Actively suicidal/homicidal;
• Active psychosis.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• University of Colorado, Denver: collaborator
• Indiana University School of Medicine: collaborator
• Oregon Social Learning Center: collaborator

Study Sites (2)

CU Medicine Psychiatry - Outpatient Clinic

Aurora, Colorado, 80045, United States

Location

ARTS - Synergy Outpatient Services

Denver, Colorado, 80236, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Carla Kmett Danielson, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Paula Riggs, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be monitored by the Principal Investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Carla Kmett Danielson, Principal Investigator

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: October 15, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (2)