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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916614
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
PTSD Stress, Psychological Gunshot Wound Behavioral: Screening Tool for Relief of Trauma (START) Behavioral: standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence:
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: START treatment
Participants randomized into the treatment arm will receive the START intervention as described above alongside usual care from the VPOP staff
Behavioral: 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

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. PTSD evaluation [ Time Frame: baseline ]
    Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C)

  2. Change in PTSD evaluation test scores [ Time Frame: 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.

  3. Change PTSD evaluation test scores [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916614


Contacts
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Contact: Kathleen O'Neill, MD 203-843-4583 kathleen.oneill@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Kathleen O'Neill    410-530-4221    kathleen.oneill@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: James Dodington, MD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03916614    
Other Study ID Numbers: 2000025580
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds, Gunshot
Stress, Psychological
Behavioral Symptoms
Wounds, Penetrating
Wounds and Injuries