NCT05821205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

April 6, 2023

Last Update Submit

April 23, 2026

Conditions

Keywords

Gun

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (6)

Narrative Persuasion (randomized weekly, 1 of 4 options)

EXPERIMENTAL

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.

Behavioral: Narrative Persuasion

Reciprocity (randomized weekly, 1 of 4 options)

EXPERIMENTAL

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

Behavioral: Reciprocity

Commitment (randomized weekly, 1 of 4 options)

EXPERIMENTAL

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

Behavioral: Commitment

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

NO INTERVENTION

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

The control condition will involve no personalized feedback. Randomized monthly

Personalized feedback (randomized monthly, 1 of 2 options)

EXPERIMENTAL

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.

Behavioral: Personalized Feedback

Interventions

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.

Narrative Persuasion (randomized weekly, 1 of 4 options)
ReciprocityBEHAVIORAL

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

Reciprocity (randomized weekly, 1 of 4 options)

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

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

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

Commitment (randomized weekly, 1 of 4 options)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employed at study site
  • Participate in screening and/or SafERteens delivery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Trinity Health Medical Group, Academic Family Medicine - Fruitport

Fruitport, Michigan, 49415, United States

Location

Muskegon Pediatrics

Muskegon, Michigan, 49440, United States

Location

HealthWest Youth and Family Services

Muskegon, Michigan, 49442, United States

Location

Trinity Health - Community Health And Well-Being

Muskegon, Michigan, 49444, United States

Location

Trinity Health-Emergency Department

Muskegon, Michigan, 49444, United States

Location

Study Officials

  • Patrick Carter, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, University of Michigan Institute for Firearm Injury Prevention Associate Professor, Department of Emergency Medicine

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 20, 2023

Study Start

February 28, 2023

Primary Completion

April 13, 2026

Study Completion

April 13, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations