RECRUITING

Project Safe Guard-Trauma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized controlled trial is to determine if a counseling intervention, Project Safe Guard-Trauma (PSG-T), increases secure firearm storage practices in adults who screen positive for posttraumatic stress disorder (PTSD). The main questions this study aims to answer are: * Does PSG-T lead to more secure firearm storage practices? * Does PSG-T increase knowledge about the link between firearm storage practices and suicide risk? * Does PSG-T increase intentions to store firearms securely? Researchers will compare PSG-T to a control, Project Safe Guard (PSG), which is a counseling intervention that does not focus on the potential influence of PTSD symptoms on firearm storage practices. This will help to determine if PSG-T works better than PSG to increase secure firearm storage in adults with elevated PTSD symptoms. Participants will: * Complete a baseline survey * Receive the counseling intervention * Complete a survey immediately after the intervention and at 1-, 3-, and 6-months following the intervention

Official Title

Project Safe Guard-Trauma (PSG-T): A Randomized Controlled Trial of Counseling to Promote a Secure Home Environment

Quick Facts

Study Start:2025-05-15
Study Completion:2028-09-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06876740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18+ years
  2. * Firearm owner
  3. * History of one or more victimization traumas per the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (LEC-5), defined as having directly experienced physical assault, sexual assault, combat, and/or captivity
  4. * Positive posttraumatic stress disorder (PTSD) screen on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
  5. * Willing to provide physical location at time of Zoom sessions
  6. * Willing to keep Zoom camera on during study sessions
  7. * Ability to read, write, and speak English
  1. * Currently stores all personal firearms unloaded and locked
  2. * Active psychosis or acute mania necessitating clinical intervention
  3. * Acute thoughts of self- or other-harm necessitating imminent clinical intervention (e.g., hospitalization)
  4. * Unable to provide informed consent

Contacts and Locations

Study Contact

Ian Stanley, PhD
CONTACT
720-848-6777
ian.stanley@cuanschutz.edu
Julia Finn, MPH
CONTACT
(303) 653-6000
emed_stanleylab@cuanschutz.edu

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-15
Study Completion Date2028-09-14

Study Record Updates

Study Start Date2025-05-15
Study Completion Date2028-09-14

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Firearm Injury
  • Suicide Prevention
  • Firearm safety

Additional Relevant MeSH Terms

  • PTSD
  • Firearm Injury
  • Suicide Prevention
  • Firearm Safety