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

Sponsor
Nantes University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02774863
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Home passages

Study Design

Study Type:
Observational
Actual Enrollment :
6 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?
Actual Study Start Date :
Nov 23, 2016
Actual Primary Completion Date :
Jul 5, 2017
Actual Study Completion Date :
Jul 5, 2017

Arms and Interventions

Arm Intervention/Treatment
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
Three home passages between the 2nd and 3rd months of follow up.

Outcome Measures

Primary Outcome Measures

  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). [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical-social Center Dalby Millet Nantes France 44000
2 Medical-Social center Bellevue Nantes France 44100
3 Medical-social center Pilotière Nantes France 44300
4 Medical-Social center Port Boyer Nantes France 44300
5 Medical-social Saint-Servan Saint-Herblain France 44800
6 Medical-social St-Etienne de Montluc St-Etienne de Montluc France 44360

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02774863
Other Study ID Numbers:
  • RC15_0445
First Posted:
May 17, 2016
Last Update Posted:
Aug 9, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Aug 9, 2017