- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05784662
Social Workers Addressing Firearm Risk (SAFR)
Evaluating the Social Workers Addressing Firearm Risk (SAFR) Intervention: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Buffalo, New York, United States, 14260
- Online Only
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Practicing social worker
- In New York
- Age 18 or older
- English proficiency
Exclusion Criteria:
- Not meeting above criteria
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
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).
|
Educational intervention for social workers.
Other Names:
|
|
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
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.
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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
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00006636
- UL1TR001412 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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