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- Klinische proef 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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Nantes, Frankrijk, 44000
- Medical-social Center Dalby Millet
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Nantes, Frankrijk, 44100
- Medical-Social center Bellevue
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Nantes, Frankrijk, 44300
- Medical-social center Pilotière
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Nantes, Frankrijk, 44300
- Medical-Social center Port Boyer
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Saint-Herblain, Frankrijk, 44800
- Medical-social Saint-Servan
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St-Etienne de Montluc, Frankrijk, 44360
- Medical-social St-Etienne de Montluc
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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.
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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.
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Three home passages between the 2nd and 3rd months of follow up.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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).
Tijdsspanne: up to three months
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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
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- RC15_0445
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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