Translation of an Intervention for Violence Among Adolescents in Emergency Departments

Violence Clinical Trial

Official title:

Translation of an Intervention for Violence Among Adolescents in Emergency Departments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923492
• Other study ID #: R49CE002099
• Status: Completed
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: August 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. During the Effectiveness phase, we will determine the effectiveness of the interventions [on-site therapist delivered BI + text messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the BI groups. During the Implementation phase, components of the RE-AIM model will be assessed over a 4-month period.

Description:

Participants who screen positive for the study during the effectiveness phase, will be randomized to either the therapy or control at a rate of 2:1. Whether the participant receives the on-site therapist or the remote therapist will depend on day of week or shift. Over the course of the study, the proportion of shifts covered by on-site verses remote therapists will be balanced for seasonality and time of day (evening vs. day time).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• youth (ages 14-18) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);

• access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).

• Positive past 3 month violence screen criteria: Youth will be eligible for the study if they endorse on self-report computer survey past three month violence perpetration

Exclusion Criteria:

• youth who do not understand English

• youth deemed unable to provide informed assent/consent by ED or research staff

• prisoners at time of ED presentation.

• youth who present to the ED as victims of sexual abuse or child abuse

Related Conditions & MeSH terms

• Emergencies
• Violence

Intervention

Behavioral:
• SafERteens
A 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Hurley Medical Center Emergency Department	Flint	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	Peer violence behaviors	as assessed with the modified Conflict Tactic Scale	Change from baseline to 3 months
Primary	Violence Consequences	as assessment with a scale developed in the original SafERteens study	Change from baseline to 3 months
Secondary	Self-Efficacy for non-violence	As assessed with the Teen Conflict Survey	Change from baseline to 3 months
Secondary	Attitude towards viiolence	as assessed with the Attitudes Towards Violence Scale	Change from baseline to 3 months