An interventional study of Implementation package (training and facilitation) in Suicide, sponsored by Northwestern University. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Northwestern University · Not applicable, Interventional, and Health services research
Among 386 studies in Suicide with a site in United States — 99 open to participants now, 113 under way, 2 of them phase 3. Suicide · United States.
Among the 386 studies in Suicide with a site in United States, this one is the 35th largest by planned enrollment of the 348 interventional ones, is one of 32 that started in 2026, is one of 288 with no phase, reaches primary completion later than 90 of the 112 other live ones, and was the 348th registered.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's planned enrollment of 1,086 is above the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →99 of the 386 studies in Suicide with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 114 Suicide studies recruiting now, 54 (47%) set no upper age limit and 57 (50%) stop at 75 or younger; 52 take children under 18; 24 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →386 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 32 started in 2026.
Median enrollment 91 across the 348 interventional studies, 172 across the 36 observational. Of the 251 that completed or were terminated, 103 (41%) have results posted.
15 of 386 have an industry lead sponsor. The 10 most frequent:
Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Northwestern University has 3 studies filed under Suicide — fewer than ten, so there is no comparison to draw.
43 of the studies in Suicide with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05696691Phase 3The University of Texas Health Science Center at San AntonioKetamine & Crisis Response Plan for Suicidal Ideation in the ED | 2026-12-31 |
| NCT05558332University of California, IrvineYouth Nominated Support Team | 2026-11 |
| NCT06470867VA Office of Research and DevelopmentRandomized Controlled Effectiveness Trial of VA S.A.V.E. | 2026-11-27 |
| NCT05897164Evidence-Based Practice Institute, Seattle, WAMobile Technology to Reduce Teen Substance Misuse | 2026-11-30 |
| NCT06460220Jennifer HughesSAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth | 2026-12 |
Among the 386 studies in Suicide with a site in United States, from their registry updates:
This randomized controlled trial will take place in up to 15 community health centers across the state of Illinois. Researchers will be studying S.A.F.E. Firearm, a program that aims to increase secure storage of firearms in homes with children. Specifically, S.A.F.E. Firearm includes a brief conversation between pediatric clinicians and parents/guardians about secure firearm storage and an offer of a free cable firearm lock within the well-child visit. Researchers will also study a package of strategies to help pediatric clinics incorporate this new practice. The strategies include training for clinic personnel and facilitation, or tailored problem-solving support.
The questions the study aims to answer are:
Some parents will be invited to complete a brief survey after their visit about their experiences receiving S.A.F.E. Firearm. Some community health center personnel will also be invited to complete an interview about their experiences with S.A.F.E. Firearm and the package of strategies.
While some large health systems have successfully implemented secure firearm storage programs such as S.A.F.E. Firearm into routine practice, there is limited research on the implementation of secure firearm storage programs in community settings, such as community health centers, which serve large populations of Americans. These settings often face challenges such as financial pressures and high staff turnover, which were made worse by the COVID-19 pandemic. Therefore, before deploying a secure firearm storage program in this new setting, adaptation is needed. As part of Aim 1 of the grant funding this project, the research team is working with local community-based organizations, firearm safety experts, community health center personnel, and parents, guardians, and caregivers (hereafter, "parents") to understand the changes that need to be made to the S.A.F.E. Firearm program and the package of implementation strategies that have been successfully used in previous studies to help pediatric clinics implement this new practice (training, facilitation). The research team will incorporate needed changes before the present trial will begin.
In the present study, the research team will conduct a hybrid type III effectiveness-implementation trial to test the effect of the adapted S.A.F.E. Firearm program and associated strategies. The trial will be conducted across pediatric well-visits in community health centers across the state of Illinois using a stepped wedge design. Clinics will be randomized into clusters of clinics and the implementation approach (staff training, facilitation) will be activated upon the start of each step.
Aims for the study include:
Aim 2. We will conduct a pragmatic hybrid type III stepped wedge effectiveness-implementation randomized controlled trial with community health centers across Illinois to test the effectiveness of our adapted implementation approach on parent-reported receipt of S.A.F.E. Firearm (i.e., reach; co-primary implementation outcome) and distribution of cable locks by the clinics (co-primary implementation outcome). We will also assess secondary implementation outcomes (stage of implementation, cost, acceptability) and effectiveness outcomes (parent firearm storage behavior).
Aim 3. We will use mixed methods to identify mechanisms.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parent participants
Health care personnel
Exclusion Criteria:
During the control data collection phase, no individuals will be exposed to S.A.F.E. Firearm. No training or facilitation will be received. The length of the baseline data collection phase will differ between each "wedge" (i.e., group of clinics) depending on when the group is randomly assigned to cross over into the active implementation phase. All sites will be in the control data collection phase for at least three months before having the interventions activated.
Once a group of clinics crosses over from the control data collection phase, the implementation approaches (e.g., training, facilitation) and the S.A.F.E. Firearm program will be enacted. S.A.F.E. Firearm involves pediatric clinicians having a secure firearm storage discussion with a parent during their child's well-visit and offering them a free cable firearm lock. This active implementation phase will last for 12 months.
Behavioral: Implementation package (training and facilitation)
Following the conclusion of the 12 months in which the implementation approaches (training and facilitation) are used at a clinic, outcomes will be assessed for the duration of the study during a "sustainment" window. No additional training or facilitation will be received during the sustainment period following the experimental period. However, clinics will still continue to deliver S.A.F.E. Firearm.
Training includes an initial presentation on S.A.F.E. Firearm, S.A.F.E. Firearm informational guides and other resources to support delivery, and recommendations for additional, optional self-guided learning resources. Facilitation will last twelve months at each site. It may involve 1) a pre-implementation readiness assessment for each clinic to identify potential implementation barriers and develop relationships with constituents; 2) kick-off meetings, at which clinic staff will confirm how and where S.A.F.E. Firearm will be implemented within the clinic; 3) goal-setting; 4) trouble-shooting to address barriers identified during the pre-implementation readiness assessment and emergent challenges; and 5) designing a sustainment plan to maintain S.A.F.E. Firearm for future years.
Reach
The proportion of eligible parents who report receiving both S.A.F.E. Firearm intervention components (counseling and lock). The two questions comprising reach ask the parent to report whether the following occurred during their child's recent visit: a member of the health center staff (1) spoke to them about firearm storage and (2) offered them a free firearm lock(s), even if they didn't take one. Response options to each of these questions include: yes, no, don't remember, and prefer not to answer.
Time frame: 2.5 years (duration of the study - control through sustainment)
Locks distributed
The distribution of locks taken during the control phase, active implementation phase, and sustainment phase. Locks for distribution during the active implementation and sustainment phases will be ordered through the study team only. The study team will reach out to each clinic approximately 1 week prior to start of active implementation to ask how many locks were distributed during the control period. The study team will then track how many locks are ordered from each clinic and obtain an estimate from clinics 1 week prior to the end of active implementation of how many locks were distributed during the active implementation phase, and do the same for sustainment.
Time frame: 2.5 years (duration of the study - control through sustainment)
Firearm storage behavior
Firearm storage behavior will be ascertained via parental self-report. These parents will be asked whether, since their child's visit, they've taken any actions to ensure their child cannot access firearm(s) without permission. Parents will be able to select one or multiple response options: unloaded, locked, locked ammunition separate from firearm(s), talked to someone else about ensuring the child cannot access firearm(s), other, no action, or prefer not to answer. Parents will also be provided with definitions and graphics that depict locked, unloaded, and locking ammunition separately.
Time frame: 2.5 years (duration of the study - control through sustainment)
Acceptability
Acceptability will be measured using the brief questions used in our prior "ASPIRE" trial (R01MH123491), which ask whether the parent found it acceptable to have the secure firearm storage conversation; and whether they found it acceptable to have free firearm lock(s) offered to them during the visit. Response options for both: yes, no, prefer not to answer. Participants who report not receiving S.A.F.E. Firearm will be asked if they would have found these components acceptable.
Time frame: 2.5 years (duration of the study - control through sustainment)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2029, 29 months after the start.
Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 29 months is close to that.
Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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