Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence

Not Applicable

Completed

• Conditions: Stress, Psychological; PTSD; Gunshot Wound
• Interventions: Behavioral: standard of care; Behavioral: Screening Tool for Relief of Trauma (START)

• Registration Number: NCT03916614
• Lead Sponsor: Yale University

Brief Summary

To test the hypothesis that adult individuals who are victims of gun violence will have decreased symptoms of post-traumatic stress after an individual-level intervention with the Screening and Tool for Awareness and Relief of Trauma (START).

Detailed Description

In response to the lack of targeted mental health intervention for gunshot wound survivors, the Screening and Tool for Awareness and Relief of Trauma (START) was developed for patients that come from communities with sustained and persistent trauma. It consists of six screening questions adapted from the validated Primary Care PTSD Screen,\[30\] with input from focus groups, surveys and in-depth interviews with victims of violence and in particular, boys and young men of color. START has been shown to be effective at decreasing symptoms of PTSD in a one-month follow-up, but it has not been piloted on recently injured victims of gun violence specifically nor has it been tested in a randomized control trial design. A better understanding of the utility of this tool and others like it in victims of violent crime for relief of symptoms of post-traumatic stress and prevention of PTSD would contribute to the larger body of literature on PTSD prevention for victims of gun violence while simultaneously addressing a major need in this community.

Study Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2020-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Survivors of gunshot wound presenting to the Emergency room and/or admitted as inpatient that are eligible for the Violence Prevention and Outreach Program (VPOP).

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Exclusion Criteria

• Patients with severe traumatic brain injury
• Children under the age of 18
• Patients otherwise unable to give consent
• Non-English speaking patients
• Victims of sexual assault
• Patients with history of a severe mental illness and/or those already undergoing treatment for a mental illness by a licensed professional.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard of care	standard of care	Those randomized to the control arm will receive the usual screening for PTSD and referral for outpatient services if warranted as well as usual care from VPOP staff.
START treatment	Screening Tool for Relief of Trauma (START)	Participants randomized into the treatment arm will receive the START intervention as described above alongside usual care from the VPOP staff

Primary Outcome Measures

Name	Time	Method
PTSD evaluation	baseline	Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C)
Change in PTSD evaluation test scores	12 weeks	Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) A decrease in PCL-C score greater than or equal to 5 points relative to controls.
Change PTSD evaluation test scores	6 months	Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) A decrease in PCL-C score greater than or equal to 5 points relative to controls.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States