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

Violence in Adolescence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821205
• Other study ID #: HUM00220789
• Secondary ID: 5-U01-CE-003382-
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Patrick Carter, MD
• Phone: 734-647-6125
• Email: cartpatr[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Violence in Adolescence

Intervention

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.
• Reciprocity
Researchers will track clicking on the gift card as a measure of engagement
• Personalized Feedback
Researchers will track clicking on a link and/or opening to review visual data as a source of engagement.
• Commitment
Providers will receive a commitment message and be asked to reply as a measure of engagement.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Trinity Health Medical Group, Academic Family Medicine - Fruitport	Fruitport	Michigan
United States	Helen DeVos Children's Hospital Emergency Department	Grand Rapids	Michigan
United States	Hackley Community Care Medical Services	Muskegon	Michigan
United States	HealthWest Youth and Family Services	Muskegon	Michigan
United States	Muskegon Pediatrics	Muskegon	Michigan
United States	Trinity Health-Emergency Department	Muskegon	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.