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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

Study Summary

This trial will test whether a new integrative treatment is more effective than standard care in reducing substance use and PTSD symptoms in adolescents presenting for outpatient substance use disorder treatment.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverOTHER
1,738 Previous Clinical Trials
2,149,314 Total Patients Enrolled
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
142,581 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,423 Total Patients Enrolled

Media Library

RRFT (Risk Reduction through Family Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05384223 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Treatment as Usual (TAU): Encompass, RRFT (Risk Reduction through Family Therapy)
Post-Traumatic Stress Disorder Clinical Trial 2023: RRFT (Risk Reduction through Family Therapy) Highlights & Side Effects. Trial Name: NCT05384223 — N/A
RRFT (Risk Reduction through Family Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384223 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for enrolment in this research initiative?

"Affirmative. Per the information posted on clinicaltrials.gov, this research project is still recruiting patients who meet its criteria as of August 2nd 2022 and was first published on 1st August 2022. 212 participants are needed from 3 different medical centres in total."

Answered by AI

Are individuals who are over the age of 35 able to join this trial?

"According to the requirements of this clinical trial, potential participants must be aged between 13 and 18 years old. There are currently 108 trials that involve minors while 485 address elderly patients."

Answered by AI

What goals does this medical trial aim to accomplish?

"This clinical trial has a primary objective of assessing the efficacy of this medication by looking at UCLA PTSD Index DSM V - Change from baseline in UCLA PTSD total score @ 3,6, and 12 months. Secondary outcomes include Urine Drug Screen - Between group comparison -total # negative UDS /total # 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); as well as Timeline Follow Back (TLFB) - Average quantity of specific substance used on days"

Answered by AI

Who is qualified to partake in this clinical trial?

"This clinical trial seeks to recruit 212 adolescents aged between 13 and 18 who have experienced a traumatic event as defined by DSM-V PTSD Criteria A, including but not limited to child sexual abuse, physical abuse, domestic violence, or community violence. In addition they must exhibit 5+ current DSM-V symptoms of PTSD and also demonstrate substance use in the past 90 days prior to their screening session. All participants are required to speak English fluently."

Answered by AI

Is the enrollment of participants currently ongoing for this research?

"Clinicaltrials.gov confirms that this medical exploration, which was initially listed on August 1st 2022, is looking for participants. The most recent changes were made the following day (August 2nd)."

Answered by AI

Who else is applying?

What site did they apply to?
CU Medicine Psychiatry - Outpatient Clinic
ARTS - Synergy Outpatient Services
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Because it weighs on my mental abilities.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. CU Medicine Psychiatry - Outpatient Clinic: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Evaluation of RRFT for Co-occurring SUD and PTSD Among Teens
Carla Kmett Danielson 2022. "Evaluation of RRFT for Co-occurring SUD and PTSD Among Teens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05384223.
~123 spots leftby Jun 2026
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