Psychological First Aid for Victims of Crime

April 10, 2015 updated by: Medical University of South Carolina
This study aims to implement and refine research protocols required for a full-scale randomized controlled trial of Psychological First Aid (PFA) for adult victims of crime. PFA is a promising acute intervention designed to reduce the severity and duration of trauma-related distress. Law Enforcement Victim Advocates are being trained to implement PFA with adult crime victims. A pilot trial is comparing PFA to usual victim advocacy services on key psychiatric outcomes from baseline through 4 months post-baseline.

Study Overview

Detailed Description

Criminal victimization represents a major public health problem in the United States. As many as one-third of adults have been the victim of a violent crime (rape/sexual assault, physical assault, or armed robbery) during their lifetime, and individuals exposed to violence are at risk for developing chronic psychiatric problems, including posttraumatic stress disorder (PTSD), depression, and substance abuse.

The high prevalence of psychopathology among crime victims underscores the importance of effective interventions for this population. As such, considerable work has validated formal treatments for victims who have already developed chronic trauma-related difficulties. Very little effort, however, has been devoted to testing acute interventions that can be implemented soon after a crime event (i.e., within 4 weeks) with the ultimate aim of preventing longer-term psychiatric problems.

Despite the limited research on acute interventions for crime victims, researchers recently developed an acute intervention called Psychological First Aid (PFA) for individuals exposed to natural disasters or other catastrophic events. Important for present purposes, however, researchers have argued that the primary PFA components (Contact and Engagement, Stabilization, Information Gathering, Safety Planning, Practical Assistance, Connection with Social Supports, Information on Coping, and Linkage with Collaborative Services) also have direct relevance for victims of crime. Thus, we propose that PFA could represent an ideal approach for responding to the acute needs of crime victims, with the goal of reducing their risk for development of chronic psychiatric problems. Importantly, although PFA has been strongly advocated by trauma experts, there have been no empirical tests of the model, highlighting the importance of the proposed research.

Thus, this R34 project aims to implement and refine research protocols required for a full-scale randomized controlled trial of PFA for crime victims. Specifically, this project will examine the feasibility of a protocol for recruiting, assessing, and retaining acute crime victims in the study (Aim 1). Additional preliminary work that is essential for treatment research also will be completed, including the development and evaluation of a PFA fidelity instrument (Aim 2) and the refinement and testing of protocols for training paraprofessionals (i.e., Victim Advocates) to deliver PFA with a high level of fidelity (Aim 3). Finally, a controlled pilot study will examine the effects of PFA on the key psychiatric outcomes (Aim 4).

Study Type

Interventional

Enrollment (Actual)

200

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

    • South Carolina
      • Charleston, South Carolina, United States
        • Charleston County Sheriff's Office
      • Charleston, South Carolina, United States
        • City of Charleston Police Department

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Victim of a rape/sexual assault, physical assault, or armed robbery
  • Experience of a physical injury or perceived life threat during the assault

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychological First Aid
Behavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault.
Active Comparator: Usual victim advocacy services
Standard victim advocacy services delivered to crime victims within 1 month of the assault.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the frequency and severity of posttraumatic stress disorder symptoms as measured by the National Stressful Events PTSD Scale
Time Frame: Baseline, 1-, 2-, & 4-months post-baseline
Baseline, 1-, 2-, & 4-months post-baseline
Change in the frequency and severity of general anxiety, depression, and somatic symptoms as measured by the Brief Symptom Inventory-18
Time Frame: Baseline, 1-, 2-, & 4-months post-baseline
Baseline, 1-, 2-, & 4-months post-baseline
Change in the frequency and severity of substance use as measured by the Addiction Severity Index-Self Report
Time Frame: Baseline, 1-, 2-, & 4-months post-baseline
Baseline, 1-, 2-, & 4-months post-baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the frequency of exposure to traumatic events as measured by the Trauma Assessment for Adults-Brief Version
Time Frame: Baseline, 1-, 2-, & 4-months post-baseline
Baseline, 1-, 2-, & 4-months post-baseline
Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report
Time Frame: 1-, 2-, & 4-months post-baseline
1-, 2-, & 4-months post-baseline
Change in the utilization of formal treatment services as measured by the Service Utilization Form
Time Frame: 1-, 2-, & 4-months post-baseline
1-, 2-, & 4-months post-baseline
Change in the frequency of contact between Victim Advocates and crime victims as measured by the Advocate Contact Form
Time Frame: Up to 9 months following randomization of the advocates to the PFA and usual services conditions
Up to 9 months following randomization of the advocates to the PFA and usual services conditions
Change in the level of PFA implementation by Victim Advocates as measured by the PFA Fidelity Form
Time Frame: Up to 9 months following randomization of the advocates to the PFA and usual services conditions
Up to 9 months following randomization of the advocates to the PFA and usual services conditions

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Michael R. McCart, Ph.D., Medical University of South Carolina

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

June 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

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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