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Translation of an Intervention for Violence Among Adolescents in Emergency Departments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923492
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Maureen A Walton, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Violence Behavioral: SafERteens Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Translation of an Intervention for Violence Among Adolescents in Emergency Departments
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : February 15, 2018

Arm Intervention/treatment
Experimental: In-person Therapy by ED Staff
Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person.
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

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

No Intervention: Comparison Group
This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).



Primary Outcome Measures :
  1. Peer violence behaviors [ Time Frame: Change from baseline to 3 months ]
    as assessed with the modified Conflict Tactic Scale

  2. Violence Consequences [ Time Frame: Change from baseline to 3 months ]
    as assessment with a scale developed in the original SafERteens study


Secondary Outcome Measures :
  1. Self-Efficacy for non-violence [ Time Frame: Change from baseline to 3 months ]
    As assessed with the Teen Conflict Survey

  2. Attitude towards viiolence [ Time Frame: Change from baseline to 3 months ]
    as assessed with the Attitudes Towards Violence Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923492


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Hurley Medical Center Emergency Department
Flint, Michigan, United States, 48503
Sponsors and Collaborators
University of Michigan
Centers for Disease Control and Prevention

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Responsible Party: Maureen A Walton, Associate Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT02923492    
Other Study ID Numbers: R49CE002099 ( U.S. NIH Grant/Contract )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes