Prevention of Post Sexual Assault Stress

March 14, 2016 updated by: Medical University of South Carolina

Prevention of Postrape Drug Abuse: Replication Study

The purpose of this study is to evaluate whether a brief intervention in video format, that includes education about reactions to assault and modeling of adaptive coping strategies, designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of sexual assault at the time of receipt of post assault medical care is associated with better post-assault outcomes as compared to a comparable length video that includes pleasant imagery and relaxation instruction or standard care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Post assault outcomes include coping behaviors and PTSD symptoms.

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55422
        • North Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Seeking medical care after recent sexual assault

Exclusion Criteria:

  • Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PPRS video
Prevention of post sexual assault stress
Behavioral: PPRS
Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
Active Comparator: PIRI video
Pleasant imagery and relaxation instruction
Behavioral: PIRI
Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
No Intervention: Standard care
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Abuse Screening Test (DAST-10)
Time Frame: 6 months
total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
6 months
Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: 6 months
Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months
6 months
Cigarettes (Estimated Number)
Time Frame: 14 days preceding 6 week, 3 month and 6 month follow-up
quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
14 days preceding 6 week, 3 month and 6 month follow-up
Amount of Alcohol Use
Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up
estimated number of drinks during the 14 days prior to each follow-up assessment
14 days prior to 6 week, 3 month, 6 month follow-up
Marijuana Use Frequency
Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up
Number of days of use within the 14 days prior to follow-up assessment
14 days prior to 6 week, 3 month, 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any Other Illicit Drug Use
Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up
Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up
14 days prior to 6 week, 3 month, 6 month follow-up
Non-medical Use of Prescription Drugs Frequency
Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up
Number of days of use within the 14 days prior to follow-up assessment
14 days prior to 6 week, 3 month, 6 month follow-up
PTSD Symptom Scale Self-Report (PSS-SR)
Time Frame: 2 weeks prior to 6 week, 3 month, 6 month followup
Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.
2 weeks prior to 6 week, 3 month, 6 month followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Heidi Resnick, Ph.D., Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA023099 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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