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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH091203 (U.S. NIH Grant/Contract)

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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