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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05821205
Enrollment
240
Registered
2023-04-20
Start date
2023-02-28
Completion date
2027-12-31
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Violence in Adolescence

Keywords

Gun

Brief summary

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.

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.

Interventions

BEHAVIORALNarrative 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.

BEHAVIORALReciprocity

Researchers will track clicking on the gift card as a measure of engagement

Researchers will track clicking on a link and/or opening to review visual data as a source of engagement.

BEHAVIORALCommitment

Providers will receive a commitment message and be asked to reply as a measure of engagement.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Providers or staff (n=240) participating in screening (e.g., nurses) and/or intervention delivery (e.g., social workers, child life, community health workers) will be consented/enrolled in the MRT, each person randomized weekly with equal probability to one of three ES or control and also randomized monthly to receive personalized feedback or no personalized feedback.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Preliminary Efficacy: weekly reach by providersFrom the start of implementation to 52 weeks or the end of provider's employment if before 52 weeks.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.
Preliminary Efficacy: monthly reach by providersFrom the start of implementation to 52 weeks or the end of provider's employment if before 52 weeks.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.

Countries

United States

Contacts

Primary ContactPatrick Carter, MD
cartpatr@med.umich.edu734-647-6125
Backup ContactKaty Clark
katymc@med.umich.edu734-615-8706

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026