What side effects are associated with this type of intervention?

Common treatments for PTSD, such as exposure-based cognitive behavioral therapy (CBT) and pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs), have known side effects. Exposure-based CBT can lead to temporary increases in anxiety, distress, or emotional discomfort. SSRIs, like sertraline, may cause nausea, insomnia, sexual dysfunction, and weight gain. Combining these treatments can introduce a broader range of side effects from both modalities.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms by regulating serotonin levels in the brain. Additionally, exposure-based psychotherapies, which involve confronting trauma-related memories and stimuli in a controlled manner, are widely recognized as effective treatments for PTSD. While the FDA has not specifically approved integrative treatments like Risk Reduction through Family Therapy (RRFT), which combines exposure-based therapy with family involvement and targets both substance use problems and PTSD, the components of such therapies are supported by existing evidence and clinical practice guidelines.

What other types of research exist?

Promising novel alternatives to RRFT for PTSD patients include Heart Assisted Therapy (HAT), which has shown significant reductions in distress levels post-treatment, and in vivo exposure group therapy, which has demonstrated a significant decrease in PTSD symptoms. Both therapies offer innovative approaches and have shown promising results in clinical studies.

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RRFT for Substance Use and PTSD in Teens

N/A

Recruiting

Led By Carla Kmett Danielson, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 13-18 years

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at baseline, 3, 6, & 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment called Risk Reduction through Family Therapy (RRFT) for teens aged 13-18 who have both substance use problems and PTSD due to past trauma. RRFT combines different therapy methods to treat both issues at the same time, involving the family in the process. The goal is to see if this approach works better and if it can be effectively used in regular outpatient settings. Risk Reduction through Family Therapy (RRFT) is an integrative and exposure-based treatment approach for adolescents with substance use problems and PTSD, developed to address the gap in effective treatments for this population.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions are psychosocial therapies rather than medications, typical drug side effects aren't expected. However, discussing traumatic events during therapy could potentially cause emotional discomfort or a temporary increase in distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 13 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at baseline, 3, 6, & 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at baseline, 3, 6, & 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at baseline, 3, 6, & 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RRFT (Risk Reduction through Family Therapy)Experimental Treatment1 Intervention

Group II: Treatment as Usual (TAU): EncompassActive Control1 Intervention

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for PTSD, such as integrative, exposure-based therapies, work by helping patients confront and process traumatic memories in a controlled setting. This mechanism reduces the emotional and behavioral impact of these memories, alleviating symptoms like hyperarousal and avoidance. For PTSD patients, this approach is vital as it not only targets the core symptoms of PTSD but also addresses co-occurring issues like substance use problems, leading to a more comprehensive and effective treatment outcome.

Theoretical and empirical issues in the treatment of post-traumatic stress disorder in Vietnam veterans.Treating PTSD in Pregnant and Postpartum Rural Women with Substance Use Disorders.