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

NCT02774863 | Terminated

• 1 other identifier: RC15_0445
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 6

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.

Conditions

Emotional Neglect

Outcome Measures

Primary Outcomes (1)

• 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).

  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

Study Arms (2)

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.

Other: Home passages

Interventions

Home passages OTHER

Three home passages between the 2nd and 3rd months of follow up.

Group "Home passages"

Eligibility Criteria

• Age: 1 Year - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Fifty children and their families (parents / guardians) will be included in the research in the department of Loire-Atlantique, coming visit to the Mother and Child Protection within the first two years of their child.

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

Medical-social Center Dalby Millet

Nantes, 44000, France

Location

Medical-Social center Bellevue

Nantes, 44100, France

Location

Medical-social center Pilotière

Nantes, 44300, France

Location

Medical-Social center Port Boyer

Nantes, 44300, France

Location

Medical-social St-Etienne de Montluc

Saint-Étienne-de-Montluc, 44360, France

Location

Medical-social Saint-Servan

Saint-Herblain, 44800, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 17, 2016
• Study Start: November 23, 2016
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)