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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00527358
Other study ID # CDC-NCIPC-4924
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 6, 2007
Last updated February 8, 2012
Start date September 2006
Est. completion date December 2010

Study information

Verified date February 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This is an evaluation of a primary prevention program to prevent youth violence by improving family cohesion, networking among families, school bonding, and access to services for Latinos in Langley Park, MD.


Description:

To prevent youth involvement in violence, outreach workers will work with families and youth to improve school bonding, family cohesion and awareness and utilization of existing services; and a youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.

Following implementation of the intervention, we will collect detailed process data (regarding implementation), and evaluate impact/outcome using a quasi-experimental design with baseline (prior to intervention) and two followup data collections in both the intervention and a control community (Culmore, Virginia), measuring change in a selected set of aggregate community variables that represent mediating factors and outcomes for youth violence in Langley Park. Data will be collected via a survey and focus groups.


Recruitment information / eligibility

Status Completed
Enrollment 1400
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 24 Years
Eligibility Inclusion Criteria:

- youth 12-24 and their caregiver

Exclusion Criteria:

- residence outside of Langley Park or Culmore

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)
community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices; youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, provide education about avoiding violence; school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals; Youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.

Locations

Country Name City State
United States George Washington University Washington District of Columbia

Sponsors (4)

Lead Sponsor Collaborator
Joanne Klevens George Washington University, Latin American Youth Center, Latino Federation of Greater Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Youth violence within the next 2 years after intervention started No
Secondary family cohesion within the next 2 years after start of intervention No
Secondary school bonding within the next 2 years after start of intervention No
Secondary exposure to antisocial, substance abusing, or violent peers within the next 2 years after start of intervention No
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