Michigan Youth Violence Prevention Center: Building Evidence for Gun Violence Prevention - SafERteens Implementation

The purpose of this study is to determine the preliminary efficacy (via a micro-randomized trial [MRT] design) of augmenting Enhanced-Replicating Effective Program (E-REP) with engagement strategies to increase and sustain reach by healthcare providers (e.g., nurses, social workers) during implementation of the SafERteens program across multiple healthcare settings.

Study Overview

• Status: Completed
• Conditions: Violence in Adolescence
• Intervention / Treatment: Behavioral: Narrative Persuasion; Behavioral: Reciprocity; Behavioral: Commitment; Behavioral: Personalized Feedback

Detailed Description

This proposal examines whether augmenting the Enhanced-Replicating Effective Program (E-REP) implementation strategy with theory-based engagement strategies (ES) for healthcare providers (i.e., nurses; social workers) improves reach during the implementation of SafERteens across multiple healthcare settings.

SafERteens is a single-session behavioral intervention combining motivational interviewing (MI) and cognitive-behavioral skills training (CBT) shown to reduce multiple violence outcomes, including non-partner (i.e., peer) aggression, non-partner and partner victimization, and violence consequences (e.g., truancy) among emergency department (ED) youth with recent fighting and drinking.

No prior studies have examined the effect of adding individual engagement strategies to an E-REP package or examined the effect of repeatedly applying such strategies over time to enhance implementation of an evidence-based intervention.

In this study, the researchers will test four ES: Narrative Persuasion Strategies, Reciprocity Strategies, Personalized Feedback Strategies, and Commitment Strategies.

The researchers will employ a micro-randomized trial (MRT) design - - a novel experimental design for constructing time-varying m-health interventions. In MRTs, individuals are randomly assigned to intervention options, repeatedly-- at multiple time points over the course of the trial. The data can be used to examine the causal effects of specific ES on a proximal outcome (i.e., reach), changes in these effects over time, and the individual or contextual factors that moderate ES.

In this hybrid type 3 trial, the researchers will embed an MRT testing randomized, weekly delivery of three ES strategies outlined above (and a control option -- no ES) and monthly delivery of Personalized Feedback (and a control option -- No feedback) and will examine preliminary efficacy of those engagement strategies at increasing reach of the implemented SafERteens program. The researchers will also explore potential signals for individual (e.g., age, clinical role), within-individual (e.g., prior engagement), and organizational (e.g., implementation climate) moderators of preliminary ES efficacy, as well as examine comparisons between different ES and trends in their efficacy over time.

This is a portion of a larger study. Although the first consent was signed on February 2023 the clinical trial portion of the study did not start until April 2023. U-M IRBMED initially deemed the study as Exempt from its oversight until September 2023 when U-M IRBMED approved it as a standard study HUM00220789.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Fruitport, Michigan, United States, 49415
      • Trinity Health Medical Group, Academic Family Medicine - Fruitport
    • Muskegon, Michigan, United States, 49440
      • Muskegon Pediatrics
    • Muskegon, Michigan, United States, 49442
      • HealthWest Youth and Family Services
    • Muskegon, Michigan, United States, 49444
      • Trinity Health - Community Health And Well-Being
    • Muskegon, Michigan, United States, 49444
      • Trinity Health-Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Employed at study site
• Participate in screening and/or SafERteens delivery.

Exclusion Criteria:

• Would not be expected to complete screening and/or intervention delivery
• Would not begin screening and/or delivering SafERteens within the first 9 months of cohort implementation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Narrative Persuasion (randomized weekly, 1 of 4 options); Narrative persuasion will be youth or provider testimonial about violence in their community and/or how SafERteens helped their development and reduced violence. Randomized weekly.	Behavioral: Narrative Persuasion; Narratives will use anonymous testimonials from our prior work combined with open-source pictures. The researchers will ask participants to rate the testimonial message as a measure of engagement.
Experimental: Reciprocity (randomized weekly, 1 of 4 options); The reciprocity engagement strategy (ES) will be operationalized as an unsolicited $5 gift card with the SafERteens Logo. Randomized weekly.	Behavioral: Reciprocity; Researchers will track clicking on the gift card as a measure of engagement
Experimental: Commitment (randomized weekly, 1 of 4 options); Commitment will be operationalized as a pledge committing to screening and/or delivering SafERteens (depending on role). Randomized weekly.	Behavioral: Commitment; Providers will receive a commitment message and be asked to reply as a measure of engagement.
No Intervention: Engagement Strategy Control (randomized weekly, 1 of 4 options); The control condition will involve no ES for the weekly Engagement Strategies. Randomized weekly.
No Intervention: Personalized feedback control (randomized monthly, 1 of 2 options); The control condition will involve no personalized feedback. Randomized monthly
Experimental: Personalized feedback (randomized monthly, 1 of 2 options); The feedback ES will be operationalized as a visual graphic of their personal performance screening and/or delivering SafERteens in relation to the mean of the provider group and/or towards a pre-set standard (i.e., screening 75% of adolescents; delivery rate of 75% of eligible youth). Personalized feedback or none will be randomized on a monthly basis.	Behavioral: Personalized Feedback; Researchers will track clicking on a link and/or opening to review visual data as a source of engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary Efficacy: weekly reach by providers	Reach is defined as the number of participants screened or the number of participants to whom the intervention was delivered. The researchers hypothesize that during weeks where providers receive an engagement strategy (ES), reach will be higher than weeks where no ES is received.	From the start of implementation to 52 weeks or the end of provider's employment if before 52 weeks.
Preliminary Efficacy: monthly reach by providers	Reach is defined as the number of participants screened or the number of participants to whom the intervention was delivered. The researchers hypothesize that during months where providers receive personalized feedback, reach will be higher than months where no ES is received.	From the start of implementation to 52 weeks or the end of provider's employment if before 52 weeks.

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Patrick Carter, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): April 13, 2026
• Study Completion (Actual): April 13, 2026

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gun
• Other Study ID Numbers: HUM00220789; 5-U01-CE-003382-02-00 (Other Grant/Funding Number: Centers for Disease Control and Prevention); 5U01CE003382-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No