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.

Study Overview

• Status: Terminated
• Conditions: Emotional Neglect
• Intervention / Treatment: Other: Home passages

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Medical-social Center Dalby Millet
  • Nantes, France, 44100
    • Medical-Social center Bellevue
  • Nantes, France, 44300
    • Medical-social center Pilotière
  • Nantes, France, 44300
    • Medical-Social center Port Boyer
  • Saint-Herblain, France, 44800
    • Medical-social Saint-Servan
  • St-Etienne de Montluc, France, 44360
    • Medical-social St-Etienne de Montluc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2016
• Primary Completion (Actual): July 5, 2017
• Study Completion (Actual): July 5, 2017

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RC15_0445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No