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Firearm Safety Support Program for Suicide Prevention (ASPIRE Trial)
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cost data will be collected from pre-implementation through sustainment (30 months total)
Awards & highlights
ASPIRE Trial Summary
This trial is testing whether adding a year of support to help clinics implement a firearm safety program will result in more well-visits having S.A.F.E. Firearm delivery documented in the electronic health record.
Who is the study for?
This trial is for parents with children aged 5-17 attending a well visit at participating pediatric clinics. Parents must be over 18 and present during the visit. It also includes clinicians and health system leaders within these clinics, but excludes certain family medicine clinicians and non-English speaking or non-US resident parents at Henry Ford Health System.Check my eligibility
What is being tested?
The study compares two methods of implementing S.A.F.E. Firearm, a suicide prevention program in pediatric care: 'Nudge', an electronic record prompt for firearm safety discussion and lock offer; and 'Nudge+', which adds one year of support to clinics. The goal is to see if these lead to better program delivery and reduced unauthorized firearm access by youth.See study design
What are the potential side effects?
Since this trial involves implementation strategies rather than medical treatments, traditional side effects are not applicable. However, there may be indirect effects on clinic workflow or patient-clinician interactions that will be monitored.
ASPIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cost data will be collected from pre-implementation through sustainment (30 months total)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cost data will be collected from pre-implementation through sustainment (30 months total)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reach
Secondary outcome measures
Clinician-reported acceptability
Cost
Distribution of cable locks
+2 moreASPIRE Trial Design
2Treatment groups
Experimental Treatment
Group I: Nudge+Experimental Treatment1 Intervention
This arm consists of Nudge as described above, as well as facilitation. Facilitation (i.e., external support delivered by health system employees not employed within the clinic site) will be offered for 12 months to each clinic, in keeping with other implementation trials. The investigators will use a train-the-trainer model to train facilitators at both health systems to ensure they achieve facilitator core competencies with an eye toward implementation of S.A.F.E. Firearm. The role of the facilitator is to engage with study clinics, to assist each clinic in setting change and performance goals around the implementation of S.A.F.E. Firearm, and to troubleshoot implementation barriers.
Group II: NudgeExperimental Treatment1 Intervention
Clinics randomized to the Nudge condition will receive the EHR prompt only. The investigators will add default language to the standard Well Child Visit workflow to serve as a reminder and allow for tracking of S.A.F.E. Firearm implementation. The clinician will be asked to denote whether the program was delivered (e.g., whether conversation around firearm storage was conducted, whether cable firearm lock was offered) to the parent during the visit. This EHR prompt will remain turned "on" from active implementation through the sustainment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nudge
2022
N/A
~8850
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,640,632 Total Patients Enrolled
112 Trials studying Suicide
1,108,344 Patients Enrolled for Suicide
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
868,756 Total Patients Enrolled
3 Trials studying Suicide
18,057 Patients Enrolled for Suicide
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,831,613 Total Patients Enrolled
16 Trials studying Suicide
9,038 Patients Enrolled for Suicide
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a parent over 18 with a child aged 5-17 going for a check-up.
Research Study Groups:
This trial has the following groups:- Group 1: Nudge+
- Group 2: Nudge
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants enrolling in this experiment currently?
"Clinicaltrials.gov states that this clinical trial is no longer actively searching for participants, having first been posted on March 14th 2022 and last updated the following week. Nevertheless there are 168 alternative studies enrolling patients at present."
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