Violence, Non-accidentalNCT02393092
Violence Prevention Study for Youth Age 10-15
A study testing Brief Violence Awareness, Brief Violence Prevention and Emerging Leaders: East End curriculum in people with Violence, Non-accidental, run by Virginia Commonwealth University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Violence, Non-accidental
- What is being tested?
- Brief Violence Awareness, Brief Violence Prevention and Emerging Leaders: East End curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to 8 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MLK Middle School Boys and Girls Club
Richmond, Virginia, 23223
VCU Pediatric Emergency Department
Richmond, Virginia, 23298
About this study
Official title: A Youth Violence Prevention Initiative: A VCUHS and Boys and Girls Club of Metro Richmond Initiative
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:
Read more
- 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.
- Brief violence awareness (BVA): a packet of information about violence prevention and local community resources.
- 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.
Specifically, it is hypothesized that:
- Participants will report more positive youth behaviors as compared to their initial assessment.
- Participants will report lower levels of risky youth behaviors compared to their initial assessment.
- Participants will report increased interest in and knowledge of health professions.
- Participants will report reduced levels of delinquency compared to their initial assessment.
- Participants will report a reduction in the number of violence related hospital visits compared to the general 23223 population.
- Hospital data will show a reduction in violence related activities that led to hospital visits, or delinquent behavioral involvement.
Read the detailed description
The study will include children living in the 23223 zip code of the City of Richmond, who attend Martin Luther King Middle School, and who are between the ages 10-15. The study will recruit from two sites. These sites include the Pediatric Emergency Department at VCU Medical Center and the Boys and Girls Club of Metro Richmond, Martin Luther King Middle School site. Upon recruitment, consent, and assessment, the children will receive either 1) a BVP only, 2) a BVA only or 3) a BVP as well as participation in a semester-long positive youth development program called Emerging Leaders: East End. The randomization process among all three groups will be done through sequential selection. Youth will be assigned to one of the three groups on a rotating, sequential basis as they enroll.
The study will assess behaviors, attitudes, family function, violence exposure, mental health, medical needs and service needs. The study will compare within group differences between a group that receives the BVP intervention and attends the Emerging Leaders: East End program, one that only receives the BVP intervention, one that receives a BVA intervention package only and one that receives the BVA or BVP and attends the Boys and Girls club but does not participate in the Emerging Leaders: East End program.
All groups will take an assessment every nine weeks through Grade 12 or until youth end their participation in this study. The assessment tool includes topics such as exposure to violence, family functioning and mental health. Case managers will administer the assessment.
Within the overall goal of reducing subsequent health risk for young victims of intentional injuries and their families, the violence reduction effort will address the following objectives:
- Develop detailed profiles of participants treated at the Pediatric Emergency Department through a detailed behavior and attitude assessment battery given in an interview format. Additionally, this information will be used to increase understanding of the needs of this at-risk population for the purpose of developing preventive services. Data from these assessments will also be used in the preparation of scholarly papers on this patient population and the impact of this program on their recidivism.
- Provide brief violence prevention (BVP) intervention to youth to review conflict-resolution strategies, increase their awareness of youth's risk factors for recidivism, explore coping skills, and develop safety plan services and supports that may be responsive to their needs and reduce the likelihood of future risk of intentional injury.
- Provide brief violence awareness (BVA) intervention to provide basic information on the prevalence, impact of violence and the available community resources.
- Provide comprehensive case management to participants in order to maintain program involvement.
- Provide a curriculum consisting of skill building, educational development, increased exposure to health careers and internship opportunities.
- Conditions
- Violence, Non-accidental
- Being tested
- Brief Violence Awareness, Brief Violence Prevention, Emerging Leaders: East End curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Violence AwarenessBehavioural
The Brief Violence Awareness (BVA) will consist of a packet of information about violence prevention and local community resources.
Brief Violence PreventionBehavioural
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.
Emerging Leaders: East End curriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BVA Only | Experimental | Study participants in this arm will only receive a Brief Violence Awareness (BVA) intervention. Receives: Behavioral: Brief Violence Awareness |
| BVP Only | Experimental | Study participants in this arm will only receive a Brief Violence Prevention (BVP) intervention. Receives: 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. Receives: Behavioral: Brief Violence Prevention; Behavioral: Emerging Leaders: East End curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Annually for the duration of this study, up to seven years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJul 2015
- Primary completion8 Jul 2016
- Study completion8 Jul 2016
Why it stopped: It was determined that internal resources to support this population would be better utilized in other Injury and Violence Prevention Programs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence, Non-accidentalStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Boys and Girls Clubs of Metro Richmond
- Responsible party
- Sponsor
- Investigators
- Michel Aboutanos, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393092
- Sponsor's protocol ID
- HM20002499
- Status last verified
- Nov 2017
- First submitted
- 3 Mar 2015
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Youth Violence Prevention Initiative: A VCUHS and Boys and Girls Club of Metro Richmond Initiative
- ClinicalTrials.gov ID
- NCT02393092
- Acronym / sponsor ID
- HM20002499
- Conditions
- Violence, Non-accidental
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was determined that internal resources to support this population would be better utilized in other Injury and Violence Prevention Programs.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Boys and Girls Clubs of Metro Richmond
- Study start
- Jul 2015
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 8 Jul 2016 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Brief violence awareness (BVA): a packet of information about violence prevention and local community resources.
- 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.
Specifically, it is hypothesized that:
- Participants will report more positive youth behaviors as compared to their initial assessment.
- Participants will report lower levels of risky youth behaviors compared to their initial assessment.
- Participants will report increased interest in and knowledge of health professions.
- Participants will report reduced levels of delinquency compared to their initial assessment.
- Participants will report a reduction in the number of violence related hospital visits compared to the general 23223 population.
- Hospital data will show a reduction in violence related activities that led to hospital visits, or delinquent behavioral involvement.
Detailed description
The study will include children living in the 23223 zip code of the City of Richmond, who attend Martin Luther King Middle School, and who are between the ages 10-15. The study will recruit from two sites. These sites include the Pediatric Emergency Department at VCU Medical Center and the Boys and Girls Club of Metro Richmond, Martin Luther King Middle School site. Upon recruitment, consent, and assessment, the children will receive either 1) a BVP only, 2) a BVA only or 3) a BVP as well as participation in a semester-long positive youth development program called Emerging Leaders: East End. The randomization process among all three groups will be done through sequential selection. Youth will be assigned to one of the three groups on a rotating, sequential basis as they enroll.
The study will assess behaviors, attitudes, family function, violence exposure, mental health, medical needs and service needs. The study will compare within group differences between a group that receives the BVP intervention and attends the Emerging Leaders: East End program, one that only receives the BVP intervention, one that receives a BVA intervention package only and one that receives the BVA or BVP and attends the Boys and Girls club but does not participate in the Emerging Leaders: East End program.
All groups will take an assessment every nine weeks through Grade 12 or until youth end their participation in this study. The assessment tool includes topics such as exposure to violence, family functioning and mental health. Case managers will administer the assessment.
Within the overall goal of reducing subsequent health risk for young victims of intentional injuries and their families, the violence reduction effort will address the following objectives:
- Develop detailed profiles of participants treated at the Pediatric Emergency Department through a detailed behavior and attitude assessment battery given in an interview format. Additionally, this information will be used to increase understanding of the needs of this at-risk population for the purpose of developing preventive services. Data from these assessments will also be used in the preparation of scholarly papers on this patient population and the impact of this program on their recidivism.
- Provide brief violence prevention (BVP) intervention to youth to review conflict-resolution strategies, increase their awareness of youth's risk factors for recidivism, explore coping skills, and develop safety plan services and supports that may be responsive to their needs and reduce the likelihood of future risk of intentional injury.
- Provide brief violence awareness (BVA) intervention to provide basic information on the prevalence, impact of violence and the available community resources.
- Provide comprehensive case management to participants in order to maintain program involvement.
- Provide a curriculum consisting of skill building, educational development, increased exposure to health careers and internship opportunities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BVA Only | Experimental | Behavioral: Brief Violence AwarenessStudy participants in this arm will only receive a Brief Violence Awareness (BVA) intervention. |
| BVP Only | Experimental | Behavioral: Brief Violence PreventionStudy participants in this arm will only receive a Brief Violence Prevention (BVP) intervention. |
| Emerging Leaders plus BVP | Experimental | Behavioral: Brief Violence Prevention, Behavioral: Emerging Leaders: East End curriculumStudy 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Reside in the 23223 zip code of the City of Richmond
- Attend Martin Luther King Middle School
- Be between the ages 10-15.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Violence AwarenessThe Brief Violence Awareness (BVA) will consist of a packet of information about violence prevention and local community resources. | Behavioural | BVA Only |
| Brief Violence PreventionThe 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. | Behavioural | BVP Only, Emerging Leaders plus BVP |
| Emerging Leaders: East End curriculumThe 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. | Behavioural | Emerging Leaders plus BVP |
Primary outcome
Behaviors and attitudes related to violence - assessment consisting of select questions from various tools.
Time frame: 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.
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.
2 secondary outcomes
Reduction in the number of violence related hospital visits
Time frame: 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
Time frame: Annually for the duration of this study, up to seven years.
Results and safety
The study was stopped early (reason given: It was determined that internal resources to support this population would be better utilized in other Injury and Violence Prevention Programs.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Aboutanos principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Violence Awareness, Brief Violence Prevention and Emerging Leaders: East End curriculum in people with Violence, Non-accidental, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was determined that internal resources to support this population would be better utilized in other Injury and Violence Prevention Programs.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviors and attitudes related to violence - assessment consisting of select questions from various tools. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.