Psychological First Aid for Victims of Crime
Primary Purpose
Posttraumatic Stress Disorder, Depression, Substance Use
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Psychological First Aid
Usual victim advocacy Services
Sponsored by
About this trial
This is an interventional prevention trial for Posttraumatic Stress Disorder
Eligibility 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
Sites / Locations
- Charleston County Sheriff's Office
- City of Charleston Police Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Psychological First Aid
Usual victim advocacy services
Arm Description
Behavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault.
Standard victim advocacy services delivered to crime victims within 1 month of the assault.
Outcomes
Primary Outcome Measures
Change in the frequency and severity of posttraumatic stress disorder symptoms as measured by the National Stressful Events PTSD Scale
Change in the frequency and severity of general anxiety, depression, and somatic symptoms as measured by the Brief Symptom Inventory-18
Change in the frequency and severity of substance use as measured by the Addiction Severity Index-Self Report
Secondary Outcome Measures
Change in the frequency of exposure to traumatic events as measured by the Trauma Assessment for Adults-Brief Version
Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report
Change in the utilization of formal treatment services as measured by the Service Utilization Form
Change in the frequency of contact between Victim Advocates and crime victims as measured by the Advocate Contact Form
Change in the level of PFA implementation by Victim Advocates as measured by the PFA Fidelity Form
Full Information
NCT ID
NCT01934348
First Posted
August 27, 2013
Last Updated
April 10, 2015
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01934348
Brief Title
Psychological First Aid for Victims of Crime
Official Title
Psychological First Aid for Victims of Crime
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression, Substance Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychological First Aid
Arm Type
Experimental
Arm Description
Behavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault.
Arm Title
Usual victim advocacy services
Arm Type
Active Comparator
Arm Description
Standard victim advocacy services delivered to crime victims within 1 month of the assault.
Intervention Type
Behavioral
Intervention Name(s)
Psychological First Aid
Intervention Type
Behavioral
Intervention Name(s)
Usual victim advocacy Services
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report
Time Frame
1-, 2-, & 4-months post-baseline
Title
Change in the utilization of formal treatment services as measured by the Service Utilization Form
Time Frame
1-, 2-, & 4-months post-baseline
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. McCart, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charleston County Sheriff's Office
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
City of Charleston Police Department
City
Charleston
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Psychological First Aid for Victims of Crime
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