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

University of Michigan

Status: Enrolling

Conditions: Violence in Adolescence

Treatments: Behavioral: Commitment; Behavioral: Personalized Feedback; Behavioral: Narrative Persuasion; Behavioral: Reciprocity

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05821205

5-U01-CE-003382-02-00 (Other Grant/Funding Number)

HUM00220789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

240 participants in 6 patient groups

Narrative Persuasion (randomized weekly, 1 of 4 options)

Experimental group

Description:

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.

Treatment:

Behavioral: Narrative Persuasion

Reciprocity (randomized weekly, 1 of 4 options)

Experimental group

Description:

The reciprocity engagement strategy (ES) will be operationalized as an unsolicited $5 gift card with the SafERteens Logo. Randomized weekly.

Treatment:

Behavioral: Reciprocity

Commitment (randomized weekly, 1 of 4 options)

Experimental group

Description:

Commitment will be operationalized as a pledge committing to screening and/or delivering SafERteens (depending on role). Randomized weekly.

Treatment:

Behavioral: Commitment

Engagement Strategy Control (randomized weekly, 1 of 4 options)

No Intervention group

Description:

The control condition will involve no ES for the weekly Engagement Strategies. Randomized weekly.

Personalized feedback control (randomized monthly, 1 of 2 options)

No Intervention group

Description:

The control condition will involve no personalized feedback. Randomized monthly

Personalized feedback (randomized monthly, 1 of 2 options)

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Feedback