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Completed

NCT Number: NCT05821205

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative Persuasion

Behavioral

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.

Reciprocity

Behavioral

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

Personalized Feedback

Behavioral

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

Commitment

Behavioral

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

Primary outcomes

  1. Preliminary Efficacy: weekly reach by providers

    Time frame: From 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.

  2. Preliminary Efficacy: monthly reach by providers

    Time frame: From 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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