Translation of an Intervention for Violence Among Adolescents in Emergency Departments

NCT02923492 | Completed

• 1 other identifier: R49CE002099
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Violence

Outcome Measures

Primary Outcomes (2)

• Peer violence behaviors

  as assessed with the modified Conflict Tactic Scale

  Change from baseline to 3 months

• Violence Consequences

  as assessment with a scale developed in the original SafERteens study

  Change from baseline to 3 months

Secondary Outcomes (2)

• Self-Efficacy for non-violence

  Change from baseline to 3 months

• Attitude towards viiolence

  Change from baseline to 3 months

Study Arms (3)

In-person Therapy by ED Staff

EXPERIMENTAL

Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person.

Behavioral: SafERteens

Remote Therapy by Research Staff

EXPERIMENTAL

Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered remotely (over video) by research staff.

Behavioral: SafERteens

Comparison Group

NO INTERVENTION

This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).

Interventions

SafERteens BEHAVIORAL

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

In-person Therapy by ED Staff; Remote Therapy by Research Staff

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Hurley Medical Center Emergency Department

Flint, Michigan, 48503, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 4, 2016
• Study Start: February 22, 2017
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (2)