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OpenTrials
Completed

NCT Number: NCT02923492

Translation of an Intervention for Violence Among Adolescents in Emergency Departments

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.

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Key information

Conditions

Violence

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System, Ann Arbor, Michigan, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2016
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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