- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00438594
Age 9 Follow-up of Preventive Intervention (Denver) (DenverY09)
Age 9 Follow-up of Preventive Intervention
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This project supports a 9-year follow-up of 650 children and their families who were enrolled in a randomized trial of prenatal and infancy home visiting by paraprofessionals and by nurses; participating families were assigned to control, paraprofessional-, or nurse-visited conditions. Earlier phases of assessment found significant benefits for nurse- and paraprofessional-visited families and children, although the nurse effects tended to be larger. The current phase of follow-up is designed to determine whether the effects of the nurse and paraprofessional programs endure and grow through the child age 9.5.
The project is organized around seven questions:
- Do the programs of nurse and paraprofessional home-visiting produce enduring effects on: a) mothers' life-course; b) qualities of care parents provide to their children; c) children's early-onset behavior problems; d) children's incoherence and aggression/destruction in response to story stems; e) children's executive, language, and intellectual functioning and school achievement?
- To what extent are the beneficial effects of the programs on parental care-giving and children's development concentrated on those born to mothers with few psychological resources?
- To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?
- To what extent are the effects of the programs on antisocial behavior concentrated on boys? 5. To what extent are program effects moderated by school and neighborhood contexts?
6. To what extent are the effects of the programs on children's development explained by impacts of the programs on women's prenatal smoking, maternal life-course, qualities of parental caregiving, and children's earlier language development, executive functioning, and emotional regulation? 7. To what extent are the initial costs of the programs recovered in reduced expenditures for other government services during the first nine years of the first child's life?
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Women from 21 antepartum clinics serving low-income women in Denver recruited if they had no previous live births and either qualified for Medicaid or had no private insurance.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Grupo de controle
|
|
Experimental: Paraprofessional home visits
home visitation by Paraprofessional
|
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
|
Experimental: Nurse home visits
home visitation by Nurse
|
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
fewer subsequent pregnancies
Prazo: When first child is 9
|
When first child is 9
|
increased interval between the birth of the first and second child
Prazo: When first child is 9
|
When first child is 9
|
reduced use of welfare
Prazo: When first child is 9
|
When first child is 9
|
increased participation in the work force
Prazo: When first child is 9
|
When first child is 9
|
reduced behavioral problems due to use of alcohol and drugs
Prazo: When first child is 9
|
When first child is 9
|
fewer arrests
Prazo: When first child is 9
|
When first child is 9
|
increased qualities of care parents provide to their children as reflected in fewer verified reports of child abuse and neglect and observations of coercive mother-child interaction.
Prazo: When first child is 9
|
When first child is 9
|
children's early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers.
Prazo: At child age 9
|
At child age 9
|
children's aggressive and destructive themes and narrative coherence in their responses to story stems.
Prazo: At child age 9
|
At child age 9
|
executive functions and school achievement.
Prazo: At child age 9
|
At child age 9
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, Isacks K, Sheff K, Henderson CR Jr. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1560-8. doi: 10.1542/peds.2004-0961.
- Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR Jr, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486-96. doi: 10.1542/peds.110.3.486.
- Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years. JAMA Pediatr. 2014 Feb;168(2):114-21. doi: 10.1001/jamapediatrics.2013.3817.
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
Palavras-chave
Outros números de identificação do estudo
- 03-0776
- R01MH069891 (Concessão/Contrato do NIH dos EUA)
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