Gun Violence PreventionSAFRNCT05784662
Social Workers Addressing Firearm Risk
A study testing Social Workers Addressing Firearm Risk in people with Gun Violence Prevention, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Aim 2: Evaluate the preliminary efficacy of the SAFR intervention using a randomized controlled trial. An additional 100 practicing social workers (excluding participants from Aim 1) will be recruited, with n = 50 allocated to each arm of the study utilizing block randomization. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gun Violence Prevention
- What is being tested?
- Social Workers Addressing Firearm Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practicing social worker
- In New York
- Age 18 or older
- English proficiency
Who cannot join
- Not meeting above criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Social Workers Addressing Firearm Risk (SAFR) Intervention: A Pilot Study
Aim 2: Evaluate the preliminary efficacy of the SAFR intervention using a randomized controlled trial. An additional 100 practicing social workers (excluding participants from Aim 1) will be recruited, with n = 50 allocated to each arm of the study utilizing block randomization. Participants in the control arm will receive invitations to all surveys but not to the SAFR intervention itself. We will utilize the validated measures from Aim 1 to assess changes on study variables. Results will be analyzed using either mixed linear models or generalized estimating equations as appropriate. Analyses will be performed with a focus on estimation of parameters for use in the planning of a subsequent comparative trial designed to fully assess intervention efficacy with a national sample. Supportive analyses that adjust for participant covariates will also be considered. We will also ask participants for feedback on the intervention and will track indicators of feasibility and acceptability (recruitment rates, completion of intervention and measurement tools).
Read the detailed description
Specific Aim 2: Evaluate the efficacy of the SAFR intervention. Once measurement tools have been validated, we will begin to recruit for the pilot test of the SAFR intervention. Recruitment methods will be similar to those in Aim 1; individuals who participate in Aim 1 will not be eligible to participate in the trial of SAFR. Participants will be randomized equally to the control and intervention groups. Participants will be invited to enroll in the study by clicking on links in advertisement materials. The link will take them to a brief webpage with information about the study and questions screening for eligibility. Once screened, they will complete the informed consent document and await randomization. Participants in the intervention group will receive an email with instructions on how to access the pre-test measurements and the course. Because the course is online and self-paced, they will be given six weeks to complete the course, with reminders coming once a week to encourage completion. The UB SSW Continuing Education website allows us to track information about participants, including time to completion for all users; this information will be utilized to assess the acceptability of the course. The pre-test survey will include the scales assessing knowledge, attitudes, and behaviors towards assessing for risks of firearm violence among clients, in addition to a demographic survey and the Gun Control Attitudes and Gun Behaviors and Beliefs Scales. The post-test, which will be sent out one month after the pre-test, assuming that the course was successfully completed, will contain the measures regarding knowledge, attitudes, and behaviors. We will also be assessing for acceptability of the intervention by including questions that ask participants for their thoughts on the course. Finally, the follow-up will be sent three months after the completion of the post-test and will assess knowledge, attitudes, and behaviors a final time. The control group will receive the three surveys (without course feedback items) on the same timeline. At the conclusion of the study, they will be invited to receive the SAFR intervention at no cost.
Data analysis plan. To describe the observed variability in the data and test for differences between randomized groups, linear or generalized linear models will be utilized depending on the nature of the outcome. Once a given model is fit, a linear contrast based on the estimated model parameters will be constructed and used to test for the overall effect of random assignment. Point estimates and corresponding confidence intervals to quantify treatment differences will be provided. Since the comparability of randomized groups may be questioned due to chance imbalances in confounding variables, subject-level covariates known to be predictive of outcome and their interactions with randomized assignment will be added to the models as a series of supportive analyses. All analyses will be performed based on the intent-to-treat principle. The amount and nature of missing data for collected study variables will be characterized and no method of imputation will be used for missing data for primary analyses. All tests will be two-sided and tested at a 0.05 nominal significance level. Standard diagnostic plots will be used to assess model fit and transformations of variables may be considered in order to meet statistical assumptions. With the proposed sample size, mean differences of 0.6 standard deviations are detectable at 80% power. Group-specific means and proportions will be estimated with an associated confidence interval width of 0.55 standard deviations and 28 percentage points, respectively.
Hypotheses:
Aim 2: The SAFR intervention will improve social workers' knowledge of gun violence, attitudes about social workers' need to intervene with all clients, and behaviors regarding discussing guns and gun violence risks with clients compared to pre-test and the control group. We also hypothesize that the SAFR intervention will be feasible and acceptable.
- Conditions
- Gun Violence Prevention
- Being tested
- Social Workers Addressing Firearm Risk
- Keywords
- firearms, guns, social work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Workers Addressing Firearm RiskBehavioural
Also called SAFR
Educational intervention for social workers.
| Study group | Role | What they receive |
|---|---|---|
| Social Workers Addressing Firearm Risk | Experimental | The Social workers Addressing Firearm Risk (SAFR) intervention is fully-online intervention that contains four modules. Each module includes interviews with experts, didactic content, handouts, and brief quizzes to check learning (required by New York State for continuing education credit). Receives: Behavioral: Social Workers Addressing Firearm Risk |
| Control | No intervention | Wait list control. Will receive access to SAFR intervention at conclusion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge About Gun Violence
Assessed with the Knowledge about gun violence measure (novel). Theoretical minimum/maximum = 0.0/5.0. High scores indicate more knowledge about firearm safety.
Measured: Baseline, 1 month later, and 3 months later
Change in Attitudes About Firearms Safety Counseling
Assessed with the Attitudes about firearms safety counseling (novel). Theoretical minimum/maximum = 0/5.00. High scores indicate greater inclination towards discussing firearm safety with clients.
Measured: Baseline, 1 month later, and 3 months later
Change in Confidence About Firearms Safety Counseling
Assessed with the Confidence about firearms safety counseling (novel). Theoretical minimum/maximum = 0/5.00. High scores indicate greater confidence about discussing firearm safety with clients.
Measured: Baseline, 1 month later, and 3 months later
Change in Behaviors With Clients
Assessed with the Behaviors with Clients measure (novel). Theoretical minimum/maximum = 0/5.00. High scores indicate more interventions about firearm safety with clients. This scale asked questions like, "I talk to my clients about firearm access," with answers ranging from Strongly disagree to strongly agree.
Measured: Baseline, 1 month later, and 3 months later
Change in Behaviors With Clients in Last Month
Assessed with the Behaviors with Clients in last month measure (novel). Theoretical minimum/maximum = 0/2.00. Higher scores indicate more interventions about firearm safety with clients. This scale asked questions like, "In the last month, I have provided clients with information about firearm safety..." with answers specified as "none of the time," "some of the time," and "all of the time."
Measured: Baseline, 1 month later, and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start21 Aug 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gun Violence PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Patricia Logan-Greene, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784662
- Sponsor's protocol ID
- STUDY00006636
- Other IDs
- UL1TR001412
- Acronym
- SAFR
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2023
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Social Workers Addressing Firearm Risk (SAFR) Intervention: A Pilot Study
- ClinicalTrials.gov ID
- NCT05784662
- Acronym / sponsor ID
- SAFR / STUDY00006636
- Conditions
- Gun Violence Prevention
- Keywords
- firearms, guns, social work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 2: Evaluate the preliminary efficacy of the SAFR intervention using a randomized controlled trial. An additional 100 practicing social workers (excluding participants from Aim 1) will be recruited, with n = 50 allocated to each arm of the study utilizing block randomization. Participants in the control arm will receive invitations to all surveys but not to the SAFR intervention itself. We will utilize the validated measures from Aim 1 to assess changes on study variables. Results will be analyzed using either mixed linear models or generalized estimating equations as appropriate. Analyses will be performed with a focus on estimation of parameters for use in the planning of a subsequent comparative trial designed to fully assess intervention efficacy with a national sample. Supportive analyses that adjust for participant covariates will also be considered. We will also ask participants for feedback on the intervention and will track indicators of feasibility and acceptability (recruitment rates, completion of intervention and measurement tools).
Detailed description
Specific Aim 2: Evaluate the efficacy of the SAFR intervention. Once measurement tools have been validated, we will begin to recruit for the pilot test of the SAFR intervention. Recruitment methods will be similar to those in Aim 1; individuals who participate in Aim 1 will not be eligible to participate in the trial of SAFR. Participants will be randomized equally to the control and intervention groups. Participants will be invited to enroll in the study by clicking on links in advertisement materials. The link will take them to a brief webpage with information about the study and questions screening for eligibility. Once screened, they will complete the informed consent document and await randomization. Participants in the intervention group will receive an email with instructions on how to access the pre-test measurements and the course. Because the course is online and self-paced, they will be given six weeks to complete the course, with reminders coming once a week to encourage completion. The UB SSW Continuing Education website allows us to track information about participants, including time to completion for all users; this information will be utilized to assess the acceptability of the course. The pre-test survey will include the scales assessing knowledge, attitudes, and behaviors towards assessing for risks of firearm violence among clients, in addition to a demographic survey and the Gun Control Attitudes and Gun Behaviors and Beliefs Scales. The post-test, which will be sent out one month after the pre-test, assuming that the course was successfully completed, will contain the measures regarding knowledge, attitudes, and behaviors. We will also be assessing for acceptability of the intervention by including questions that ask participants for their thoughts on the course. Finally, the follow-up will be sent three months after the completion of the post-test and will assess knowledge, attitudes, and behaviors a final time. The control group will receive the three surveys (without course feedback items) on the same timeline. At the conclusion of the study, they will be invited to receive the SAFR intervention at no cost.
Data analysis plan. To describe the observed variability in the data and test for differences between randomized groups, linear or generalized linear models will be utilized depending on the nature of the outcome. Once a given model is fit, a linear contrast based on the estimated model parameters will be constructed and used to test for the overall effect of random assignment. Point estimates and corresponding confidence intervals to quantify treatment differences will be provided. Since the comparability of randomized groups may be questioned due to chance imbalances in confounding variables, subject-level covariates known to be predictive of outcome and their interactions with randomized assignment will be added to the models as a series of supportive analyses. All analyses will be performed based on the intent-to-treat principle. The amount and nature of missing data for collected study variables will be characterized and no method of imputation will be used for missing data for primary analyses. All tests will be two-sided and tested at a 0.05 nominal significance level. Standard diagnostic plots will be used to assess model fit and transformations of variables may be considered in order to meet statistical assumptions. With the proposed sample size, mean differences of 0.6 standard deviations are detectable at 80% power. Group-specific means and proportions will be estimated with an associated confidence interval width of 0.55 standard deviations and 28 percentage points, respectively.
Hypotheses:
Aim 2: The SAFR intervention will improve social workers' knowledge of gun violence, attitudes about social workers' need to intervene with all clients, and behaviors regarding discussing guns and gun violence risks with clients compared to pre-test and the control group. We also hypothesize that the SAFR intervention will be feasible and acceptable.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Social Workers Addressing Firearm Risk | Experimental | Behavioral: Social Workers Addressing Firearm RiskThe Social workers Addressing Firearm Risk (SAFR) intervention is fully-online intervention that contains four modules. Each module includes interviews with experts, didactic content, handouts, and brief quizzes to check learning (required by New York State for continuing education credit). |
| Control | No intervention | –Wait list control. Will receive access to SAFR intervention at conclusion of the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Practicing social worker
- In New York
- Age 18 or older
- English proficiency
Key exclusion criteria (1 listed)
- Not meeting above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Workers Addressing Firearm RiskAlso: SAFREducational intervention for social workers. | Behavioural | Social Workers Addressing Firearm Risk |
Primary outcome
Change in Knowledge About Gun Violence
Time frame: Baseline, 1 month later, and 3 months later
Assessed with the Knowledge about gun violence measure (novel). Theoretical minimum/maximum = 0.0/5.0. High scores indicate more knowledge about firearm safety.
Change in Attitudes About Firearms Safety Counseling
Time frame: Baseline, 1 month later, and 3 months later
Assessed with the Attitudes about firearms safety counseling (novel). Theoretical minimum/maximum = 0/5.00. High scores indicate greater inclination towards discussing firearm safety with clients.
Change in Confidence About Firearms Safety Counseling
Time frame: Baseline, 1 month later, and 3 months later
Assessed with the Confidence about firearms safety counseling (novel). Theoretical minimum/maximum = 0/5.00. High scores indicate greater confidence about discussing firearm safety with clients.
Change in Behaviors With Clients
Time frame: Baseline, 1 month later, and 3 months later
Assessed with the Behaviors with Clients measure (novel). Theoretical minimum/maximum = 0/5.00. High scores indicate more interventions about firearm safety with clients. This scale asked questions like, "I talk to my clients about firearm access," with answers ranging from Strongly disagree to strongly agree.
Change in Behaviors With Clients in Last Month
Time frame: Baseline, 1 month later, and 3 months later
Assessed with the Behaviors with Clients in last month measure (novel). Theoretical minimum/maximum = 0/2.00. Higher scores indicate more interventions about firearm safety with clients. This scale asked questions like, "In the last month, I have provided clients with information about firearm safety..." with answers specified as "none of the time," "some of the time," and "all of the time."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Workers Addressing Firearm Risk in people with Gun Violence Prevention, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge About Gun Violence (time frame: Baseline, 1 month later, and 3 months later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.