- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02774863
How to Collect the Expression of Psychological Suffering of Children Under Two Years? (RESOPSYBB)
Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?
Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.
This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.
The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Nantes, Francia, 44000
- Medical-social Center Dalby Millet
-
Nantes, Francia, 44100
- Medical-Social center Bellevue
-
Nantes, Francia, 44300
- Medical-social center Pilotière
-
Nantes, Francia, 44300
- Medical-Social center Port Boyer
-
Saint-Herblain, Francia, 44800
- Medical-social Saint-Servan
-
St-Etienne de Montluc, Francia, 44360
- Medical-social St-Etienne de Montluc
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Families say vulnerable falling M.Heaman selection criteria associated with two significant items of Q-Sort, agreeing to participate in the research project.
- Patient 24 months or less at the time of the first consultation PMI.
- Parents / legal representatives agreeing to participate in the research project.
Non inclusion Criteria:
- Serious genetic and somatic pathologies resulting deficiency, physical pain,
- Non-French speaking families.
- Families whose baby is monitored as part of the network grow together because of their prematurity.
- Minor or major Parents Trust
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Group "Maternal and Child Protection"
Followed by the doctor and pediatric nurse of the Maternal and Child Protection .
A child psychiatric consultation (usual care) can take place during the monitoring of this patient.
|
|
|
Group "Home passages"
A child psychiatric consultation is scheduled in the month following the inclusion and three home passages between the 2nd and 3rd months of follow up.
|
Three home passages between the 2nd and 3rd months of follow up.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comparison of the sensitivity of the Global Printing-scale gravity relative to the Development Quotient (reference) between the 2 supported (Group A versus Group B).
Periodo de tiempo: up to three months
|
Development Quotient level will be measured by Brunet Lezine R. This questionnaire provides an objective measure of the impact of mental suffering. It will be measured by psychomotor between the 3rd and 4th month follow up. A child with a score of QD lower or equal 85 is considered a child with developmental impairment. - Clinical Global Impression Severity Scale suitable for measuring the assessment of mental suffering of children less than two years is considered an indicator of the intensity of suffering. This will be assessed by a nurse between the 3rd and 4th months of follow up. A child with a CGI-severity score between 1 and 4 inclusive shall be considered a child with developmental impairment. |
up to three months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- RC15_0445
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .