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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02586766
Other study ID # 5U01CE001957-05
Secondary ID
Status Completed
Phase N/A
First received October 9, 2015
Last updated October 22, 2015
Start date October 2011
Est. completion date June 2015

Study information

Verified date October 2015
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 409
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 20 Years
Eligibility Inclusion Criteria:

1. adolescents (ages 14-20) presenting to the Hurley Medical Center for a medical injury or illness (except exclusions noted below);

2. adolescents will the ability to provide informed assent/consent depending on age;

3. 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);

4. currently residing in the intervention or control area;

Exclusion Criteria:

1. adolescents who do not understand English;

2. prisoners;

3. adolescents with abnormal vital signs;

4. adolescents deemed unable to provide informed consent by Emergency Department or research staff (e.g., intoxication, mental incompetence);

5. 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Project Sync
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Centers for Disease Control and Prevention

Outcome

Type Measure Description Time frame Safety issue
Primary 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 past 2 months No
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