Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD (RRFT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Medical University of South Carolina
Information provided by (Responsible Party):
Medical University of South Carolina Identifier:
First received: November 15, 2012
Last updated: March 28, 2014
Last verified: March 2014

Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use. Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.

Condition Intervention
Alcohol Use Disorders
Substance Use Disorders
Behavioral: Risk Reduction through Family Therapy
Behavioral: Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • change in substance use problems (initiation/continuation, quantity, and abuse symptoms) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change in PTSD severity and symptoms [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • change in risky sexual behaviors [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment as Usual (TAU)
Treatment as Usual (TAU) will be defined as it already exists within the community child advocacy centers. This could include individual and/or group therapy using a variety of treatment models.
Behavioral: Treatment as Usual
Participants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers. In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community. TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse.
Other Name: TAU
Experimental: RRFT
RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model.
Behavioral: Risk Reduction through Family Therapy
RRFT is an integrative, ecologically-based approach to risk reduction and treatment. A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed. This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system. Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors.
Other Name: RRFT

Detailed Description:

See above.


Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1) 13-18 years old;
  • 2) Presenting to LCC/HH for evaluation or treatment;
  • 3) Experienced CSA in their lifetime, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia;
  • 4) Have a memory of the CSA incident(s);
  • 5) Five or more DSM-IV PTSD symptoms;
  • 6) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.

Exclusion Criteria:

  • 1) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
  • 2) Actively suicidal or homicidal;
  • 3) Reports active psychotic disorder;
  • 4) Currently living with the participant's CSA perpetrator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01751035

Contact: Elizabeth McGuan, MSW 8437928361
Contact: Kathryn Soltis, BA 8437927067

United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Principal Investigator: Carla K Danielson, PhD MUSC
  More Information

No publications provided

Responsible Party: Medical University of South Carolina Identifier: NCT01751035     History of Changes
Other Study ID Numbers: Pro00009042, R01DA031285-01
Study First Received: November 15, 2012
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes processed this record on February 25, 2015