- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Nantes, Frankrike, 44000
- Medical-social Center Dalby Millet
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Nantes, Frankrike, 44100
- Medical-Social center Bellevue
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Nantes, Frankrike, 44300
- Medical-social center Pilotière
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Nantes, Frankrike, 44300
- Medical-Social center Port Boyer
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Saint-Herblain, Frankrike, 44800
- Medical-social Saint-Servan
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St-Etienne de Montluc, Frankrike, 44360
- Medical-social St-Etienne de Montluc
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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).
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- RC15_0445
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Kliniska prövningar på Emotional Neglect
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NYU Langone HealthAvslutadUnilateral Spatial Neglect (USN)Förenta staterna
Kliniska prövningar på Home passages
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National University, SingaporeNational University Hospital, SingaporeAvslutad
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Kasr El Aini HospitalOkändUrologiska kirurgiska ingreppEgypten