Back to resultsTranslation of an Intervention for Violence Among Adolescents in Emergency Departments
Primary Purpose
Violence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SafERteens
Sponsored by
About this trial
This is an interventional treatment trial for Violence
Eligibility Criteria
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
Sites / Locations
- University of Michigan Health System
- Hurley Medical Center Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
In-person Therapy by ED Staff
Remote Therapy by Research Staff
Comparison Group
Arm Description
Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person.
Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered remotely (over video) by research staff.
This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).
Outcomes
Primary Outcome Measures
Peer violence behaviors
as assessed with the modified Conflict Tactic Scale
Violence Consequences
as assessment with a scale developed in the original SafERteens study
Secondary Outcome Measures
Self-Efficacy for non-violence
As assessed with the Teen Conflict Survey
Attitude towards viiolence
as assessed with the Attitudes Towards Violence Scale
Full Information
NCT ID
NCT02923492
First Posted
October 3, 2016
Last Updated
August 24, 2018
Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02923492
Brief Title
Translation of an Intervention for Violence Among Adolescents in Emergency Departments
Official Title
Translation of an Intervention for Violence Among Adolescents in Emergency Departments
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Violence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-person Therapy by ED Staff
Arm Type
Experimental
Arm Description
Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person.
Arm Title
Remote Therapy by Research Staff
Arm Type
Experimental
Arm Description
Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered remotely (over video) by research staff.
Arm Title
Comparison Group
Arm Type
No Intervention
Arm Description
This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).
Intervention Type
Behavioral
Intervention Name(s)
SafERteens
Intervention Description
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
Primary Outcome Measure Information:
Title
Peer violence behaviors
Description
as assessed with the modified Conflict Tactic Scale
Time Frame
Change from baseline to 3 months
Title
Violence Consequences
Description
as assessment with a scale developed in the original SafERteens study
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Self-Efficacy for non-violence
Description
As assessed with the Teen Conflict Survey
Time Frame
Change from baseline to 3 months
Title
Attitude towards viiolence
Description
as assessed with the Attitudes Towards Violence Scale
Time Frame
Change from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Hurley Medical Center Emergency Department
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Translation of an Intervention for Violence Among Adolescents in Emergency Departments
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