Psychological First Aid for Victims of Crime

Depression Clinical Trial

Official title:

Psychological First Aid for Victims of Crime

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934348
• Other study ID #: R34MH091203
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 27, 2013
• Last updated: April 10, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use

Intervention

Behavioral:
• Psychological First Aid

• Usual victim advocacy Services

Locations

Country	Name	City	State
United States	Charleston County Sheriff's Office	Charleston	South Carolina
United States	City of Charleston Police Department	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the frequency and severity of posttraumatic stress disorder symptoms as measured by the National Stressful Events PTSD Scale		Baseline, 1-, 2-, & 4-months post-baseline	Yes
Primary	Change in the frequency and severity of general anxiety, depression, and somatic symptoms as measured by the Brief Symptom Inventory-18		Baseline, 1-, 2-, & 4-months post-baseline	Yes
Primary	Change in the frequency and severity of substance use as measured by the Addiction Severity Index-Self Report		Baseline, 1-, 2-, & 4-months post-baseline	No
Secondary	Change in the frequency of exposure to traumatic events as measured by the Trauma Assessment for Adults-Brief Version		Baseline, 1-, 2-, & 4-months post-baseline	No
Secondary	Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report		1-, 2-, & 4-months post-baseline	No
Secondary	Change in the utilization of formal treatment services as measured by the Service Utilization Form		1-, 2-, & 4-months post-baseline	No
Secondary	Change in the frequency of contact between Victim Advocates and crime victims as measured by the Advocate Contact Form		Up to 9 months following randomization of the advocates to the PFA and usual services conditions	No
Secondary	Change in the level of PFA implementation by Victim Advocates as measured by the PFA Fidelity Form		Up to 9 months following randomization of the advocates to the PFA and usual services conditions	No