- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00056940
Prevention of Violent Behavior Among Children
Randomized Controlled Trial to Prevent Child Violence
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
More children die violence-related deaths each year than from all natural causes combined. In 2002, the World Health Organization (WHO) reported that 1.6 million people worldwide died from violence in the year 2000; half of these deaths were due to suicides, one-third were due to homicides, and only one-fifth were war related. The United States continues to have the highest number of violence-related deaths of all developed countries.
The WHO has reviewed the effectiveness of worldwide intervention strategies and made recommendations to promote violence prevention throughout the world. Some of the common themes across all countries included: 1) because families play a fundamental role in influencing the propensity for violent behavior, efforts to provide parents with information and strategies for raising nonviolent children are needed; and 2) early interventions to reduce childhood exposure to violence are essential.
In this study, Wake Forest University Health Sciences (WFUHS) and the American Academy of Pediatrics (AAP) will collaborate to evaluate the effectiveness of a pediatric clinician's intervention that has been extensively pilot tested. Pediatric Research in Office Settings (PROS), a program of the AAP, is a national network of practice-based clinicians experienced in research participation. PROS membership consists of more than 697 practices and 1674 clinicians across the country (in 60 AAP Chapters).
This study is being conducted in primary care pediatric clinics across the country that participate in the PROS network.
PROS practices were randomly assigned to either Group 1 (violence prevention intervention) or Group 2 (literacy promotion effort). The study included a total of 137 clinics across the country, 242 practitioners, and 4,890 patients ages 2 to 11 years old. Group 1 providers received a community violence prevention resource worksheet to help them identify community specific assets. Patient families (parent/legal guardian) received tools to help them adhere to provider recommendations. Providers were trained to apply brief techniques of motivational interviewing to help ascertain patient-centered motivation to change violence-related behaviors. Patient families' knowledge, attitudes, and self-reported behaviors were examined prior to the well child exam and at 1 and 6 months after the well child exam. Baseline data were collected in the waiting room; the data forms took 10 minutes to complete. Follow-up telephone interviews were conducted at 1 and 6 months and took 10 minutes to complete.
Tipo de estudo
Inscrição
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt Universitiy School of Medicine
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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
- Parent or legal guardian seen in pediatrician's office for well child exam for their 2 to 11 year old children
- Parent/guardian is with the child the majority of time when the child is at home
- English or Spanish speaking
- Anticipate being at the same phone number for 6 to 12 months
Exclusion Criteria
- Sick child visit
- One child in family already enrolled
- No telephone contact information
- Language other than English or Spanish spoken
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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media use time
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discipline techniques used
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firearm storage patterns
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Medidas de resultados secundários
Medida de resultado |
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knowledge about appropriate media exposure for children
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knowledge about appropriate discipline techniques for children
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knowledge about appropriate safe firearm storage
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shari Barkin, MD, MSHS, Vanderbilt University School of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 1R01HD42260-1
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