NCT00998153

Brief Summary

The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, \& Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2012

Completed
Last Updated

June 18, 2018

Status Verified

May 1, 2018

Enrollment Period

5 years

First QC Date

October 19, 2009

Last Update Submit

June 15, 2018

Conditions

Keywords

substance usePTSDrisky behaviorsrevictimization

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow Back and urine screen

    Pre and post-treatment, 3 and 6 month follow-ups

Secondary Outcomes (3)

  • YRBS

    Pre and post-treatment, 3 and 6 month follow-ups

  • FES

    Pre and post-treatment, 3 and 6 month follow-ups

  • UCLA PTSD Reaction Index

    Pre, post, and 3 and 6 month follow-up

Study Arms (2)

1

EXPERIMENTAL

RRFT

Behavioral: Risk Reduction through Family Therapy

2

ACTIVE COMPARATOR

Usual care

Behavioral: Risk Reduction through Family Therapy

Interventions

Component based intervention based on existing empirically supported treatments

Also known as: RRFT
12

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • memorable sexual assault

You may not qualify if:

  • active psychosis
  • active suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Crime Victims Research and Treatment Center

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Danielson CK, McCart MR, Walsh K, de Arellano MA, White D, Resnick HS. Reducing substance use risk and mental health problems among sexually assaulted adolescents: a pilot randomized controlled trial. J Fam Psychol. 2012 Aug;26(4):628-35. doi: 10.1037/a0028862. Epub 2012 Jun 11.

MeSH Terms

Conditions

Substance-Related DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

July 1, 2006

Primary Completion

June 30, 2011

Study Completion

June 30, 2012

Last Updated

June 18, 2018

Record last verified: 2018-05

Locations