Clinical trial NCT05821205: Michigan Youth Violence Prevention Center: Building Evidence for Gun Violence Prevention - SafERteens Implementation
Official title: Michigan Youth Violence Prevention Center: Building Evidence for Gun Violence Prevention - SafERteens Implementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Violence in Adolescence
Keywords: Gun
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2023-04-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preliminary Efficacy: weekly reach by providers
timeFrame: From the start of implementation to 52 weeks or the end of provider's employment if before 52 weeks.
measure: Preliminary Efficacy: monthly reach by providers
timeFrame: From the start of implementation to 52 weeks or the end of provider's employment if before 52 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Fruitport
country: United States
facility: Trinity Health Medical Group, Academic Family Medicine - Fruitport
state: Michigan
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital Emergency Department
state: Michigan
city: Muskegon
country: United States
facility: Muskegon Pediatrics
state: Michigan
city: Muskegon
country: United States
facility: HealthWest Youth and Family Services
state: Michigan
city: Muskegon
country: United States
facility: Hackley Community Care Medical Services
state: Michigan
city: Muskegon
country: United States
facility: Trinity Health - Community Health And Well-Being
state: Michigan
city: Muskegon
country: United States
facility: Trinity Health-Emergency Department
state: Michigan
Study officials:
affiliation: University of Michigan
name: Patrick Carter, MD
role: PRINCIPAL_INVESTIGATOR
References: