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

Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02774863
Acronym
RESOPSYBB
Enrollment
6
Registered
2016-05-17
Start date
2016-11-23
Completion date
2017-07-05
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Neglect

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.

Interventions

OTHERHome passages

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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 24 Months
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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsDevelopment 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026