How to Collect the Expression of Psychological Suffering of Children Under Two Years?

Terminated

• Conditions: Emotional Neglect

• Registration Number: NCT02774863
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Study Start: 2016-11-23
• Primary Completion: 2017-07-05
• Study Completion: 2017-07-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (6)

Medical-social Center Dalby Millet; 🇫🇷 Nantes, France

Medical-Social center Bellevue; 🇫🇷 Nantes, France

Medical-social center Pilotière; 🇫🇷 Nantes, France

Medical-Social center Port Boyer; 🇫🇷 Nantes, France

Medical-social Saint-Servan; 🇫🇷 Saint-Herblain, France

Medical-social St-Etienne de Montluc; 🇫🇷 St-Etienne de Montluc, France