- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02174224
At-risk Intervention and Mentoring Evaluation (AIM)
Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months.
Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management.
Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Colorado
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Denver, Colorado, Estados Unidos, 80204
- Denver Health Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)
Exclusion Criteria:
- Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: SMC + BI + Case Management
This arm will include all interventions in Standard Medical Care + Brief Intervention Arm.
Case management will also be given to this arm.
General needs based assessments will be conducted by the outreach worker.
These assessments will be done at the hospital or at the youth's home, whichever they prefer.
This assessment tool addresses education, vocational training, employment, housing, medical insurance, follow-up care and pro-social activities.
Although each youth in this arm will receive the same needs-based assessment, individual youth will have variable needs, which will guide each unique and individualized case management plan.
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Goals of the bedside intervention will be to help the patient understand their risky behaviors that resulted in the injury and to assess and deescalate any threat of retaliatory violence by the patient.
The outreach worker will: (1) develop a rapport with the patient by introducing themselves and describing their (outreach worker's) background and reason for the bedside visit; (2) assess the emotional response to the current injury; (3) ensure the patient and/or family understand the nature of the injury and ED course; (4) address any immediate concerns of the patient; and (5) develop a plan for staying safe following discharge.
Case management based on needs-assessment.
Resource connection and mentoring.
This will include physician discretion for medical treatment and potentially a social worker visit as the physician sees fit for the patient.
This will also include a list of resources that are typically needed and used for violently injured youth.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Violence Risk Scale
Prazo: 0, 6, 12, 18 months
|
Violence Risk Scale (VRS) will be measured with each youth at 4 time points.
Change over time will be assessed and compared among study arms.
|
0, 6, 12, 18 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Composite Score
Prazo: 0, 6, 12, 18 months
|
Composite Score measures both risk and protective factors.
This weighted scale uses the interplay between risk and protective factors to determine overall risk for youth to become violently injured.
|
0, 6, 12, 18 months
|
|
School Enrollment
Prazo: 0, 6, 12, 18 months
|
Self-report for school enrollment will be measured and compared among arms.
|
0, 6, 12, 18 months
|
|
Hospital Recidivism
Prazo: 0, 6, 12, 18 months
|
Every six month, patients' medical records will be scanned to determine if there has been violent injury recidivism.
Medical release of Information forms will allow medical record searches from other local hospitals.
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0, 6, 12, 18 months
|
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Justice System Recidivism
Prazo: 0, 6, 12, 18 months
|
Self-report of criminal history.
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0, 6, 12, 18 months
|
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Employment
Prazo: 0, 6, 12, 18 months
|
Self-report of employment status.
|
0, 6, 12, 18 months
|
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Resource Utilization
Prazo: 0, 6, 12, 18 months.
|
Self report of resource utilization for health care and social needs.
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0, 6, 12, 18 months.
|
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Mortality
Prazo: 0, 6, 12, 18 months
|
Mortality will be assessed every 6 months.
|
0, 6, 12, 18 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Katie Bakes, MD, Denver Health Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- OJJDP-2013-3579
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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