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Psychological First Aid for Victims of Crime

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01934348
First received: August 27, 2013
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Depression
Substance Use
Behavioral: Psychological First Aid
Behavioral: Usual victim advocacy Services
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Psychological First Aid for Victims of Crime

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report [ Time Frame: 1-, 2-, & 4-months post-baseline ] [ Designated as safety issue: No ]
  • Change in the utilization of formal treatment services as measured by the Service Utilization Form [ Time Frame: 1-, 2-, & 4-months post-baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 237
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological First Aid
Behavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault.
Behavioral: Psychological First Aid
Active Comparator: Usual victim advocacy services
Standard victim advocacy services delivered to crime victims within 1 month of the assault.
Behavioral: Usual victim advocacy Services

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934348

Contacts
Contact: Michael R. McCart, Ph.D. 843-876-1800 mccartm@musc.edu
Contact: Kristyn Zajac, Ph.D. 843-876-1800 zajac@musc.edu

Locations
United States, South Carolina
Charleston County Sheriff's Office Recruiting
Charleston, South Carolina, United States
City of Charleston Police Department Recruiting
Charleston, South Carolina, United States
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Michael R. McCart, Ph.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01934348     History of Changes
Other Study ID Numbers: R34MH091203
Study First Received: August 27, 2013
Last Updated: August 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on November 24, 2014