NCT02393092

Brief Summary

This study will evaluate the effectiveness of a hospital-community based violence prevention pilot study designed to increase protective factors and reduce negative risk factors associated with violence of children aged 10-15. Behaviors and attitudes that relate to violence and behavior change will be assessed through a series of questionnaires administered in an interview format. Assessments will occur every nine weeks. Additionally, objective long term measures for violence related hospital visits, delinquency, and educational development will be obtained. The study will include the following interventions:

  1. 1.Brief violence prevention (BVP): a case manager administered psycho-educational intervention that will include an interactive discussion with youth regarding resources for remaining safe and preventing violence. The intervention will address the concerns and questions of youth and youth will be given information on how to access community based resources if needed.
  2. 2.Brief violence awareness (BVA): a packet of information about violence prevention and local community resources.
  3. 3.Emerging Leaders: East End: a semester (17 weeks) long curriculum based positive youth development education program held at the Boys and Girls Club of Metro Richmond, Martin Luther King Middle School site that includes case management to ensure continued engagement and participation.
  4. 4.Participants will report more positive youth behaviors as compared to their initial assessment.
  5. 5.Participants will report lower levels of risky youth behaviors compared to their initial assessment.
  6. 6.Participants will report increased interest in and knowledge of health professions.
  7. 7.Participants will report reduced levels of delinquency compared to their initial assessment.
  8. 8.Participants will report a reduction in the number of violence related hospital visits compared to the general 23223 population.
  9. 9.Hospital data will show a reduction in violence related activities that led to hospital visits, or delinquent behavioral involvement.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2016

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

March 3, 2015

Last Update Submit

November 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Behaviors and attitudes related to violence - assessment consisting of select questions from various tools.

    The assessment contains select questions from the following: Future Aspirations - Peer Leader Survey, Rochester Youth Development Study, Individual Protective Factor Index, Center for Epidemiological Studies Depression Scale for Children, Attitude Toward Interpersonal Peer Violence Scale, Children's Exposure to Community Violence Scale, Self-Reported Delinquency Problem Behavior Frequency Scale, and CDC Youth Risk Behavior Surveillance System.

    Every nine weeks up to seven years, from study enrollment through graduation from high school or participants' voluntary withdrawal from the study, whichever comes first.

Secondary Outcomes (2)

  • Reduction in the number of violence related hospital visits

    Annually for the duration of this study, up to seven years.

  • Reduction in violence related activities that led to hospital visits or delinquent behavioral involvement

    Annually for the duration of this study, up to seven years.

Study Arms (3)

BVA Only

EXPERIMENTAL

Study participants in this arm will only receive a Brief Violence Awareness (BVA) intervention.

Behavioral: Brief Violence Awareness

BVP Only

EXPERIMENTAL

Study participants in this arm will only receive a Brief Violence Prevention (BVP) intervention.

Behavioral: Brief Violence Prevention

Emerging Leaders plus BVP

EXPERIMENTAL

Study participants in this arm will participate in the Emerging Leaders: East End curriculum at the Boys and Girls Club of Metro Richmond, Martin Luther King Jr. Middle School site. They will also receive a Brief Violence Prevention (BVP) intervention.

Behavioral: Brief Violence PreventionBehavioral: Emerging Leaders: East End curriculum

Interventions

The Brief Violence Awareness (BVA) will consist of a packet of information about violence prevention and local community resources.

BVA Only

The Brief Violence Prevention (BVP) will be a psycho-educational intervention administered by a case manager that will include an interactive discussion with youth regarding resources for remaining safe and preventing violence. The intervention will address the concerns and questions of youth and youth will be given information on how to access community based resources if needed.

BVP OnlyEmerging Leaders plus BVP

The Emerging Leaders: East End curriculum focuses on positive youth development and education, which includes an emphasis on health careers. The curriculum will be administered at the Boys and Girls Club of Metro Richmond, Martin Luther King Middle School site.

Emerging Leaders plus BVP

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants must:
  • Reside in the 23223 zip code of the City of Richmond
  • Attend Martin Luther King Middle School
  • Be between the ages 10-15.

You may not qualify if:

  • Not being fluent in English
  • Developmental and cognitive delays or any other type of physical or mental problems that would prevent them from answering interview questions or participating
  • Experiencing child abuse
  • Being identified or documented as experiencing suicidal or homicidal ideation, predatory sexual behavior or perpetration of violent behavior
  • Violent behavior towards staff and/or other patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MLK Middle School Boys and Girls Club

Richmond, Virginia, 23223, United States

Location

VCU Pediatric Emergency Department

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Michel Aboutanos

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 19, 2015

Study Start

July 1, 2015

Primary Completion

July 8, 2016

Study Completion

July 8, 2016

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations