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

NCT ID: NCT03916614

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-01-01

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.

Conditions

PTSD; Stress, Psychological; Gunshot Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

START treatment

Participants randomized into the treatment arm will receive the START intervention as described above alongside usual care from the VPOP staff

Group Type: EXPERIMENTAL

Screening Tool for Relief of Trauma (START)

Intervention Type: BEHAVIORAL

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. The full START intervention requires 30-45 minutes of structured conversation at the end of which the participant leaves with a better understanding of trauma symptoms as well as on-the-spot instruction on a set of techniques designed to alleviate the symptoms of PTSD. Based on the results of their screening, the participant will be offered up to four techniques to alleviate their symptoms

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.

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: BEHAVIORAL

Screening for PTSD and referral for outpatient services if warranted as well as usual care from Violence Prevention and Outreach Program (VPOP) staff.

Interventions

Screening Tool for Relief of Trauma (START)

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. The full START intervention requires 30-45 minutes of structured conversation at the end of which the participant leaves with a better understanding of trauma symptoms as well as on-the-spot instruction on a set of techniques designed to alleviate the symptoms of PTSD. Based on the results of their screening, the participant will be offered up to four techniques to alleviate their symptoms

Intervention Type: BEHAVIORAL

standard of care

Screening for PTSD and referral for outpatient services if warranted as well as usual care from Violence Prevention and Outreach Program (VPOP) staff.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Dodington, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

References

O'Neill KM, Schenck C, Vega P, Gawel M, Dodington J. A pilot clinical trial of the Screening and Tool for Awareness and Relief of Trauma for survivors of gun violence. J Trauma Acute Care Surg. 2024 Apr 1;96(4):641-649. doi: 10.1097/TA.0000000000004121. Epub 2023 Aug 21.

Reference Type: DERIVED

PMID: 37602906 (View on PubMed)

Other Identifiers

2000025580

Identifier Type: -

Identifier Source: org_study_id