- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01294475
Preventing Child Maltreatment Through A Cellular-Phone Technology-Based Parenting Program
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The current project will employ a 3-group experimental design with random assignment of parents to one of three groups: Planned Activities Training as usual (PAT); Cellular Phone Enhanced PAT (CPAT), or a no-intervention control group. Two cohorts of high-risk mother-child dyads (low education or mother adolescent at time of birth) will be recruited. In years 1 and 2, the first cohort of participants will be recruited in Kansas City, MO and South Bend, IN from an ongoing longitudinal descriptive study of child neglect, which has tracked risk and protective factors since the child's birth (n=180). During years 3 and 4, a second cohort of matched high risk mothers (operationally defined the same as for cohort 1) will be recruited from Head Start programs within the same two communities (n=180). Families in both cohorts will be enrolled when the first family child is between the ages of 4 and 6 years.
Participants assigned to the intervention groups will receive intervention services in the home setting and will be assessed prior to the intervention, as well as at 1-, 6-, and 12- month post-intervention time points. The control group participants will complete assessments at similar time points to the intervention groups. Several outcomes will be examined in order to measure intervention effects, including child maltreatment risk and occurrences, parent behaviors, and child behaviors. These outcomes will be collected utilizing a multi-method approach that will involve parent interview, parent-report and self-report measures, mother-child observation, and review of local CPS system records. For those parents participating in an intervention group, data will also be collected on maternal engagement, retention, fidelity, and dosage with regard to the intervention. Lastly, program and participant costs will be examined to determine the cost-effectiveness of including a technological component with this existing parenting program. It is expected that the knowledge generated through this study will aid in the improvement of parenting interventions targeting the prevention of child maltreatment.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Kansas
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Lawrence, Kansas, Estados Unidos, 66045
- University of Kansas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion:
- Women between the ages of 15-18 at the time of their first child's birth OR between the ages of 22-35 years at the time of their first child's birth, with no formal education beyond high school or GED
- Mothers' oldest biological child should be between 4 and 6 years
- Families anticipate living in the 50 mile vicinity of Kansas City or South Bend for the next 18 months
- Primary caregiver should be functionally literate.
- Must speak English or Spanish fluently.
Exclusion:
- Mother has a major medical illness that could interfere with her ability to participate in a 2-year project
- Mother currently lives in a treatment program or rehab center
- Mother has a serious mental illness
- Mother lives in a group home or correctional program.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Cell Phone Enhanced Parent Training
Cell phones will be provided to mothers participating in Planned Activities Training.
|
Mothers will be provided a parenting intervention, Planned Activities Training (PAT).
Some of the mothers will receive the PAT intervention enhanced with a cell phone.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Maltrato infantil
Prazo: 12 meses
|
12 meses
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Judy Carta, Ph.D., University of Kansas
Publicações e links úteis
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 (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
- CDC-NCIPC-5054
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .