- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586766
University of Michigan Youth Violence Prevention Emergency Department Brief Intervention (Project Sync)
October 22, 2015 updated by: Rebecca Cunningham, University of Michigan
University of Michigan Youth Violence Prevention Emergency Department Brief Intervention
The purpose of this study is to determine whether a brief motivational interviewing intervention given during emergency department care to 14-20 year olds seeking treatment, could reduce youth violence.
Study Overview
Detailed Description
This Emergency Department (ED) based study will test the effectiveness of a tailored therapist delivered motivational interviewing intervention, and an informational pamphlet control condition (IC) on reducing violence in 14-20 year olds who present to the Hurley Medical Center (HMC).
Eligible adolescents at the Hurley Medical Center (HMC) emergency department (ED) (based on eligibility criteria) will complete a computerized online survey.
The goal of the intervention was to examine ways 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.
At 2-months following their ED visit, eligible adolescents (both from the intervention group and control group) will meet with a research assistant and self-administer an online computerized follow-up survey.
An online survey tool will be used for baseline, follow up and post-test surveys.
Participants will self-administer the survey at the time of follow up, post-test and baseline.
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adolescents (ages 14-20) presenting to the Hurley Medical Center for a medical injury or illness (except exclusions noted below);
- adolescents will the ability to provide informed assent/consent depending on age;
- access to a parent or guardian in person or by telephone for parental consent for adolescents ages 14-17 (over 90% of adolescents had a parent/guardian present based on our prior work);
- currently residing in the intervention or control area;
Exclusion Criteria:
- adolescents who do not understand English;
- prisoners;
- adolescents with abnormal vital signs;
- adolescents deemed unable to provide informed consent by Emergency Department or research staff (e.g., intoxication, mental incompetence);
- adolescents treated in the Emergency Department for suicide attempts or sexual assault (because they present in high psychological distress requiring intensive attention and intervention by Emergency Department staff).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral: Project Sync
Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care
|
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 did not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
violence behaviors as assessed with the combined modified Conflict Tactic Scale and the Conflict in Adolescent Dating Relationships Inventory to measure both peer and partner violence
Time Frame: past 2 months
|
past 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
October 9, 2015
First Submitted That Met QC Criteria
October 22, 2015
First Posted (Estimate)
October 26, 2015
Study Record Updates
Last Update Posted (Estimate)
October 26, 2015
Last Update Submitted That Met QC Criteria
October 22, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5U01CE001957-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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