NCT01622855

Brief Summary

The purpose of this study was to evaluate whether a brief intervention in video format delivered in the post assault medical exam setting and including education about assault reactions and instruction in and modeling of successful coping strategies would reduce post assault drug use or abuse and PTSD symptoms as compared to standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
442

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 1997

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

8.5 years

First QC Date

June 15, 2012

Last Update Submit

April 21, 2015

Conditions

Drug UseDrug AbusePosttraumatic Stress Disorder

Keywords

RapeSecondary preventionIntervention

Outcome Measures

Primary Outcomes (1)

  • Frequency of specific drug use

    Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups

    14 days

Secondary Outcomes (2)

  • Specific Drug Abuse

    1.5, 3, 6 months

  • PSS-SR

    2 weeks

Study Arms (2)

PPRS video

EXPERIMENTAL

Prevention of post sexual assault stress

Behavioral: PPRS

Standard care

NO INTERVENTION

Receipt of standard services

Interventions

PPRSBEHAVIORAL

Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.

PPRS video

Eligibility Criteria

Age14 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Seeking medical care after recent sexual assault

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heidi Resnick, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

March 1, 1997

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

US(1)