- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934348
Psychological First Aid for Victims of Crime
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States
- Charleston County Sheriff's Office
-
Charleston, South Carolina, United States
- City of Charleston Police Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Psychological First Aid
Behavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault.
|
|
|
Active Comparator: Usual victim advocacy services
Standard victim advocacy services delivered to crime victims within 1 month of the assault.
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- Principal Investigator: Michael R. McCart, Ph.D., Medical University of South Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
Fondation FondaMentalGYNOVNot yet recruitingDepression | Depression in Adults | Depression DisorderFrance
Clinical Trials on Psychological First Aid
-
NORCE Norwegian Research Centre ASCompletedPost Traumatic Stress Disorder | Adjustment DisorderNorway
-
Istanbul Medeniyet UniversityCompletedStress | Psychological Resilience | EarthquakeTurkey
-
Cairo UniversityAlexandria University; Damanhour University; Prince Sattam Bin Abdulaziz UniversityCompletedStress | Elderly | First Aid | Psychological Stress | Psychological AdaptationEgypt
-
Pontificia Universidad Catolica de ChileCompleted
-
Nurhayat Kiliç BayageldiCompletedSelf-Efficacy | Nursing Students | Crisis Intervention | Emergency PreparednessTurkey
-
Centre de Recherche de l'Institut Universitaire...UnknownDepressive Disorder | Anxiety Disorders | Stress Disorders, Post-Traumatic | Substance Abuse | Absenteeism | Acute Stress DisorderCanada
-
Abant Izzet Baysal UniversityActive, not recruitingTrauma | Psychological Trauma | Disaster; PersonalityTurkey (Türkiye)
-
Alexandria UniversityActive, not recruiting
-
Universita di VeronaUniversidad Autonoma de Madrid; London School of Economics and Political Science and other collaboratorsRecruiting
-
University of PadovaUniversita di Verona; University of Bari Aldo MoroRecruitingDepression | Anxiety | Psychological Distress | Psychological Well-BeingItaly