search
Back to results

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

Primary Purpose

PTSD, Alcohol Use Disorders, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk Reduction through Family Therapy
Treatment as Usual
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) 13-18 years old;
  • 2) Presenting to LCC/HH for evaluation or treatment;
  • 3) Report having experienced IPV in their lifetime, including: CSA, 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; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
  • 4) Have a memory of the 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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Treatment as Usual (TAU)

RRFT

Arm Description

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.

RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model.

Outcomes

Primary Outcome Measures

change in substance use problems (initiation/continuation, quantity, and abuse symptoms)

Secondary Outcome Measures

change in PTSD severity and symptoms
change in risky sexual behaviors

Full Information

First Posted
November 15, 2012
Last Updated
August 2, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01751035
Brief Title
Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD
Acronym
RRFT
Official Title
Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
July 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
See above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Alcohol Use Disorders, Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
RRFT
Arm Type
Experimental
Arm Description
RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model.
Intervention Type
Behavioral
Intervention Name(s)
Risk Reduction through Family Therapy
Other Intervention Name(s)
RRFT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in substance use problems (initiation/continuation, quantity, and abuse symptoms)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
change in PTSD severity and symptoms
Time Frame
18 months
Title
change in risky sexual behaviors
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) 13-18 years old; 2) Presenting to LCC/HH for evaluation or treatment; 3) Report having experienced IPV in their lifetime, including: CSA, 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; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence. 4) Have a memory of the 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla K Danielson, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32022827
Citation
Danielson CK, Adams Z, McCart MR, Chapman JE, Sheidow AJ, Walker J, Smalling A, de Arellano MA. Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):574-586. doi: 10.1001/jamapsychiatry.2019.4803.
Results Reference
derived

Learn more about this trial

Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD

We'll reach out to this number within 24 hrs