RRFT for Substance Use and PTSD in Teens

(STAR Trial)

Recruiting at 2 trial locations

Overseen By Deidre Bellmore, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Pervasive developmental disability, active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

212 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Risk Reduction through Family Therapy (RRFT) for teens facing both substance use problems and PTSD, a condition triggered by traumatic events. The goal is to determine if RRFT can more effectively reduce these issues compared to usual treatments. Teens who have experienced trauma, show PTSD symptoms, and have recently used substances like alcohol or drugs might be suitable candidates. Participants will be randomly assigned to receive either the new therapy or the standard treatment, with their progress tracked over a year. As an unphased trial, this study offers teens a unique opportunity to access innovative therapy that could significantly improve their well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Risk Reduction through Family Therapy (RRFT) is generally well-tolerated by teens with substance use problems and PTSD (post-traumatic stress disorder). In earlier studies, teens who completed RRFT showed significant improvements in both substance use and PTSD symptoms. These studies reported no major safety concerns or negative effects from the treatment. The therapy reduces risky behaviors through family support, effectively managing symptoms. This suggests that RRFT is a safe option for teens facing these challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for teens with substance use and PTSD, which often involve medication or traditional therapy, RRFT (Risk Reduction through Family Therapy) focuses on engaging the entire family to reduce risk factors. This method is unique because it aims to strengthen family dynamics and support systems, which can lead to more sustainable recovery outcomes. Researchers are excited about RRFT because it offers a holistic approach that targets the root of substance use and PTSD issues by fostering a supportive home environment, potentially leading to better long-term success compared to individual-focused therapies.

What evidence suggests that RRFT might be an effective treatment for substance use and PTSD in teens?

Research shows that Risk Reduction through Family Therapy (RRFT), one of the treatments in this trial, can help reduce substance use and PTSD symptoms in teens. Studies have found that RRFT leads to fewer days of substance use and less severe PTSD symptoms compared to standard treatments. For example, one study reported significant decreases in both substance use and PTSD symptoms over a year. Additionally, RRFT aids in managing emotions, potentially improving treatment outcomes. These findings suggest RRFT could be a promising option for teens dealing with both substance use and PTSD. Another treatment arm in this trial is Treatment as Usual (TAU) using the Encompass program, which serves as an active comparator. ^{1 3 4 5 6}

Who Is on the Research Team?

Carla Kmett Danielson, PhD

Principal Investigator

Medical University of South Carolina

Paula Riggs, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Teens aged 13-18 with both substance use issues and PTSD, who have experienced trauma like violence or accidents, can join this trial. They must speak English and have used substances recently. Those with severe mental disabilities, active suicidal/homicidal thoughts, or psychosis cannot participate.

Inclusion Criteria

You have at least five symptoms of PTSD according to the DSM-V guidelines.

You have experienced a traumatic event in your life, such as violence, abuse, witnessing domestic violence, or being involved in accidents or disasters.

You have used alcohol or non-tobacco drugs within the last 90 days before the study screening.

Exclusion Criteria

You have a condition that affects your ability to understand and participate in certain therapies or treatments.

You are currently having thoughts of hurting yourself or others.

You are currently experiencing severe mental health problems, such as hallucinations or delusions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either RRFT or Treatment as Usual for co-occurring SUD and PTSD

12 months

Regular visits at baseline, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up assessments at 3, 6, and 12 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)
• RRFT (Risk Reduction through Family Therapy)

Trial Overview

The study tests RRFT (Risk Reduction through Family Therapy) against usual treatments for teens with co-occurring substance use and PTSD. It aims to see if RRFT is effective in outpatient settings and to assess its cost-effectiveness and implementation factors.

How Is the Trial Designed?

Group I: RRFT (Risk Reduction through Family Therapy) Experimental Treatment 1 Intervention

Group II: Treatment as Usual (TAU): Encompass Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Indiana University School of Medicine

Collaborator

Trials

194

Recruited

181,000+

Oregon Social Learning Center

Collaborator

Trials

36

Recruited

8,900+

Published Research Related to This Trial

Multidimensional Family Therapy (MDFT) was found to be more effective than individual therapy (IP) in reducing externalising symptoms among adolescents with cannabis use disorder, based on a study involving 450 participants followed for 12 months.

Both MDFT and IP improved mental health and family functioning, but MDFT specifically showed greater success in decreasing externalising symptoms, suggesting it may be a more effective treatment option for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional family therapy decreases the rate of externalising behavioural disorder symptoms in cannabis abusing adolescents: outcomes of the INCANT trial. Schaub, MP., Henderson, CE., Pelc, I., et al.[2022]

The Risk Reduction through Family Therapy (RRFT) program was evaluated in a pilot study with 10 female adolescents aged 13-17 who had experienced sexual assault, showing promising initial efficacy in reducing substance use and trauma-related symptoms.

Participants demonstrated significant reductions in PTSD, depression symptoms, and substance use risk factors, with these improvements maintained at 3 and 6 months post-treatment, indicating the potential long-term benefits of RRFT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk reduction for substance use and trauma-related psychopathology in adolescent sexual assault victims: findings from an open trial. Kmett Danielson, C., McCart, MR., de Arellano, MA., et al.[2021]

The TARGET model is a new approach designed to treat both posttraumatic stress disorder (PTSD) and substance use disorders simultaneously, focusing on trauma and emotion self-regulation.

The model is based on extensive research and clinical literature, providing a structured skill set for therapists to use in both individual and group therapy settings, which is illustrated through real-life case examples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused, present-centered, emotional self-regulation approach to integrated treatment for posttraumatic stress and addiction: trauma adaptive recovery group education and therapy (TARGET). Ford, JD., Russo, E.[2018]

Multidimensional Family Therapy (MDFT) has been shown to be more effective than other treatments like group therapy and cognitive-behavioral therapy for adolescents with severe drug use and psychiatric issues, particularly in addressing cannabis abuse.

MDFT integrates various therapeutic techniques and focuses on the family system, which helps improve emotional expression and parental involvement, leading to better outcomes in adolescent development and substance abuse treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multidimensional family therapy: which influences, which specificities?]. Bonnaire, C., Bastard, N., Couteron, JP., et al.[2014]

Adolescents with a history of trauma are at a higher risk for developing substance use disorders (SUDs), and integrated treatment approaches are necessary to address both trauma and SUDs effectively.

A systematic review of 33 studies, including 13 randomized controlled trials, found that cognitive-behavioral therapy and other therapeutic approaches show promise in treating SUDs in traumatized youth, with exposure-based interventions yielding particularly strong results and minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for prevention and treatment of substance use in youth with traumatic childhood experiences: a systematic review and synthesis of the literature. Becker, TD., Castañeda Ramirez, S., Bruges Boude, A., et al.[2023]

In a study involving 343 women with co-occurring PTSD and substance use disorders, the integrated treatment Seeking Safety plus treatment as usual (TAU) did not show superior efficacy in reducing PTSD severity compared to TAU alone, but it did improve outcomes related to depression and emotion regulation.

Relapse Prevention Training (RPT) plus TAU was more effective than TAU alone in increasing the number of substance-free days and reducing alcohol severity, indicating that while neither integrated treatment was superior for PTSD, they both offered benefits in other areas of mental health and substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled trial of Seeking Safety vs. Relapse Prevention Training for women with co-occurring posttraumatic stress disorder and substance use disorders. Schäfer, I., Lotzin, A., Hiller, P., et al.[2020]

The pilot study involving 30 adolescents aged 13-17 showed that Risk Reduction through Family Therapy (RRFT) led to significantly greater reductions in substance use and trauma-related mental health issues, such as PTSD and depression, compared to standard treatment.

Despite the promising results for RRFT, caution is advised due to baseline differences in family functioning between the groups, highlighting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing substance use risk and mental health problems among sexually assaulted adolescents: a pilot randomized controlled trial. Danielson, CK., McCart, MR., Walsh, K., et al.[2022]

A large randomized controlled trial was conducted to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT) for adolescents who have experienced interpersonal violence, aiming to reduce substance use problems (SUP) and PTSD symptoms over an 18-month period.

The study addresses a significant gap in treatment options for adolescents facing the negative outcomes of childhood trauma, providing a structured approach to therapy that integrates exposure-based techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder symptoms in adolescents who have experienced interpersonal violence and other traumatic events. Hahn, AM., Adams, ZW., Chapman, J., et al.[2021]

Multidimensional Family Therapy (MDFT) is an evidence-based approach designed to treat adolescent substance abuse by improving functioning in four key areas: the adolescent, parents, family interactions, and external relationships.

MDFT aims to shift adolescents towards healthier developmental paths, thereby reducing the risk of substance abuse, and the review highlights the need for further research to explore its effectiveness and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping adolescents just say no to drugs: a multidimensional family therapeutic approach. Danzer, G.[2019]

Citations

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Risk Reduction through Family Therapy (RRFT)

Second, RRFT is feasibility administrated with promising outcomes for both substance use and PTSD among treatment completers –and emotional suppression may ...

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Risk Reduction through Family Therapy (RRFT) for Adolescents

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Risk reduction through family therapy (RRFT)

RRFT is an exposure-based, family intervention developed to treat PTSD and co-occurring substance use disorder (SUD) in adolescents exposed to interpersonal ...

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For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event ...

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Safety and Efficacy of Exposure-Based Risk ... - PubMed

In this study, RRFT and TAU demonstrated within-group improvements in SUP and PTSD symptoms, with greater improvement for substance use and PTSD avoidance and ...