Clinical trial NCT02923492: 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
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2016-10-04
Enrollment: 185
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Peer violence behaviors
timeFrame: Change from baseline to 3 months
measure: Violence Consequences
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Self-Efficacy for non-violence
timeFrame: Change from baseline to 3 months
measure: Attitude towards viiolence
timeFrame: Change from baseline to 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center Emergency Department
state: Michigan
Study officials:
References: