Social Workers Addressing Firearm Risk (SAFR)

February 6, 2025 updated by: Patricia Logan-Greene, State University of New York at Buffalo

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14260
        • Online Only

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Practicing social worker
  • In New York
  • Age 18 or older
  • English proficiency

Exclusion Criteria:

  • Not meeting above criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Social Workers Addressing Firearm Risk
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).
Behavioral: Social Workers Addressing Firearm Risk
Educational intervention for social workers.
Other Names:
  • SAFR
No Intervention: Control
Wait list control. Will receive access to SAFR intervention at conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month later, and 3 months later
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.
Baseline, 1 month later, and 3 months later
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.
Baseline, 1 month later, and 3 months later
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.
Baseline, 1 month later, and 3 months later
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."
Baseline, 1 month later, and 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006636
  • UL1TR001412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings