NCT01934348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 13, 2015

Status Verified

August 1, 2013

Enrollment Period

2.5 years

First QC Date

August 27, 2013

Last Update Submit

April 10, 2015

Conditions

Posttraumatic Stress DisorderDepressionSubstance Use

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (5)

  • 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

  • Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report

    1-, 2-, & 4-months post-baseline

  • Change in the utilization of formal treatment services as measured by the Service Utilization Form

    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

    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

    Up to 9 months following randomization of the advocates to the PFA and usual services conditions

Study Arms (2)

Psychological First Aid

EXPERIMENTAL

Behavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault.

Behavioral: Psychological First Aid

Usual victim advocacy services

ACTIVE COMPARATOR

Standard victim advocacy services delivered to crime victims within 1 month of the assault.

Behavioral: Usual victim advocacy Services

Interventions

Psychological First AidBEHAVIORAL
Psychological First Aid
Usual victim advocacy ServicesBEHAVIORAL
Usual victim advocacy services

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charleston County Sheriff's Office

Charleston, South Carolina, United States

Location

City of Charleston Police Department

Charleston, South Carolina, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionSubstance-Related Disorders

Interventions

Psychological First Aid

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Emergency Services, PsychiatricMental Health ServicesBehavioral Disciplines and Activities

Study Officials

  • Michael R. McCart, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 4, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 13, 2015

Record last verified: 2013-08

Locations

US(2)