Violence in AdolescenceNCT05821205
Michigan Youth Violence Prevention Center: Building Evidence for Gun Violence Prevention - SafERteens Implementation
A study testing Narrative Persuasion, Reciprocity and Personalized Feedback in people with Violence in Adolescence, run by University of Michigan at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Violence in Adolescence
- What is being tested?
- Narrative Persuasion, Reciprocity and Personalized Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Feb 2023to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employed at study site
- Participate in screening and/or SafERteens delivery.
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Trinity Health Medical Group, Academic Family Medicine - Fruitport
Fruitport, Michigan, 49415
Muskegon Pediatrics
Muskegon, Michigan, 49440
HealthWest Youth and Family Services
Muskegon, Michigan, 49442
Trinity Health - Community Health And Well-Being
Muskegon, Michigan, 49444
Trinity Health-Emergency Department
Muskegon, Michigan, 49444
About this study
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.
Read the 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.
- Conditions
- Violence in Adolescence
- Being tested
- Narrative Persuasion, Reciprocity, Personalized Feedback, Commitment
- Keywords
- Gun
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative PersuasionBehavioural
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.
ReciprocityBehavioural
Researchers will track clicking on the gift card as a measure of engagement
Personalized FeedbackBehavioural
Researchers will track clicking on a link and/or opening to review visual data as a source of engagement.
CommitmentBehavioural
Providers will receive a commitment message and be asked to reply as a measure of engagement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Personalized Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the start of implementation to 52 weeks or the end of provider's employment if before 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start28 Feb 2023
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Patrick Carter, University of Michigan
- Investigators
- Patrick Carter, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821205
- Sponsor's protocol ID
- HUM00220789
- Other IDs
- 5-U01-CE-003382-02-00, 5U01CE003382-02
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Youth Violence Prevention Center: Building Evidence for Gun Violence Prevention - SafERteens Implementation
- ClinicalTrials.gov ID
- NCT05821205
- Acronym / sponsor ID
- HUM00220789
- Conditions
- Violence in Adolescence
- Keywords
- Gun
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Narrative Persuasion (randomized weekly, 1 of 4 options) | Experimental | Behavioral: Narrative PersuasionNarrative persuasion will be youth or provider testimonial about violence in their community and/or how SafERteens helped their development and reduced violence. Randomized weekly. |
| Reciprocity (randomized weekly, 1 of 4 options) | Experimental | Behavioral: ReciprocityThe reciprocity engagement strategy (ES) will be operationalized as an unsolicited $5 gift card with the SafERteens Logo. Randomized weekly. |
| Commitment (randomized weekly, 1 of 4 options) | Experimental | Behavioral: CommitmentCommitment will be operationalized as a pledge committing to screening and/or delivering SafERteens (depending on role). Randomized weekly. |
| 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 | Behavioral: Personalized FeedbackThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employed at study site
- Participate in screening and/or SafERteens delivery.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative PersuasionNarratives 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. | Behavioural | Narrative Persuasion (randomized weekly, 1 of 4 options) |
| ReciprocityResearchers will track clicking on the gift card as a measure of engagement | Behavioural | Reciprocity (randomized weekly, 1 of 4 options) |
| Personalized FeedbackResearchers will track clicking on a link and/or opening to review visual data as a source of engagement. | Behavioural | Personalized feedback (randomized monthly, 1 of 2 options) |
| CommitmentProviders will receive a commitment message and be asked to reply as a measure of engagement. | Behavioural | Commitment (randomized weekly, 1 of 4 options) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Carter, MD principal investigator
University of Michigan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Persuasion, Reciprocity and Personalized Feedback in people with Violence in Adolescence, run by University of Michigan at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.