RRFT (Risk Reduction through Family Therapy) for Substance Use Disorders (SUD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ARTS - Synergy Outpatient Services, Centennial, CO
Substance Use Disorders (SUD)+2 More
RRFT (Risk Reduction through Family Therapy) - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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 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.

Eligible Conditions

  • Substance Use Disorders (SUD)
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Collected at baseline, 3, 6, & 12 months

Month 12
RSQ - Change from baseline in Adolescent/Child's Self-Report Responses to Family Stressors (subscale score items a-l)
Month 12
Difficulties in Emotion Regulation Scale (DERS) - Change from baseline in total score @ 3, 6, & 12 mo f/u
Month 12
Alabama Parenting Questionnaire (APQ) - positive parenting subscale, inconsistent discipline subscale, and supervision/monitoring subscale.
Timeline Follow Back (TFLB) - Change from baseline in # days non-tobacco substance used in past 28 days @ 3,6, and 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).
Timeline Follow Back (TLFB) - Average quantity of specific substance used on days of use/28 days
UCLA PTSD Index DSM V - Change from baseline in UCLA PTSD total score @ 3,6, and 12 months
Urine Drug Screen - Between group comparison -total # negative UDS /total # collected at baseline, 3, 6, & 12 months

Trial Safety

Trial Design

2 Treatment Groups

TAU:Encompass
1 of 2
RRFT (Risk Reduction through Family Therapy)
1 of 2
Active Control
Experimental Treatment

212 Total Participants · 2 Treatment Groups

Primary Treatment: RRFT (Risk Reduction through Family Therapy) · No Placebo Group · N/A

RRFT (Risk Reduction through Family Therapy)
Behavioral
Experimental Group · 1 Intervention: RRFT (Risk Reduction through Family Therapy) · Intervention Types: Behavioral
TAU:Encompass
Behavioral
ActiveComparator Group · 1 Intervention: ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: collected at baseline, 3, 6, & 12 months
Closest Location: ARTS - Synergy Outpatient Services · Centennial, CO
Photo of colorado 1Photo of colorado 2Photo of colorado 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Substance Use Disorders (SUD)
0 CompletedClinical Trials

Who is running the clinical trial?

Indiana University School of MedicineOTHER
181 Previous Clinical Trials
142,713 Total Patients Enrolled
1 Trials studying Substance Use Disorders (SUD)
100 Patients Enrolled for Substance Use Disorders (SUD)
Medical University of South CarolinaLead Sponsor
828 Previous Clinical Trials
5,371,641 Total Patients Enrolled
7 Trials studying Substance Use Disorders (SUD)
406 Patients Enrolled for Substance Use Disorders (SUD)
University of Colorado, DenverOTHER
1,554 Previous Clinical Trials
1,910,316 Total Patients Enrolled
2 Trials studying Substance Use Disorders (SUD)
500 Patients Enrolled for Substance Use Disorders (SUD)
Oregon Social Learning CenterOTHER
31 Previous Clinical Trials
9,979 Total Patients Enrolled
2 Trials studying Substance Use Disorders (SUD)
1,922 Patients Enrolled for Substance Use Disorders (SUD)
Carla Kmett Danielson, PhDPrincipal InvestigatorMedical University of South Carolina
Paula Riggs, PhDPrincipal InvestigatorUniversity of Colorado, Denver

Eligibility Criteria

Age < 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have used alcohol or non-tobacco drugs in the past 90 days.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.