Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder (TODEVA)

November 26, 2019 updated by: Camille JUNG
Dietary difficulties and eating disorders of the child are a common reason for consulting infants and young children. There is currently little data on the psychomotor development of these children and their association with parent-child attachment. The objective of this study is to evaluate, at the same time, the three physiological, psychomotor and attachment dimensions of children with eating disorders.

Study Overview

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Créteil, France, 94000
        • CHI Creteil
    • Ile De France
      • Créteil, Ile De France, France, 94000
        • CHI Creteil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children aged from 6 to 30 months with eating disorder and adressed by the pediatrician or general practitionner

Description

Inclusion Criteria:

  • Age: 6 to 30 months
  • Oral disorder defined by a MCH score ≥ 61

Exclusion Criteria:

  • Children in enteral nutrition asked for an indication other than oral disorders
  • Children followed for serious chronic organic pathology causing disorders of the oral (DNTC, swallowing disorders, etc.)
  • Child already assessed by the psychomotrician who participated in the study
  • Placement of the child in a medical institution or in a foster family.
  • Parents' refusal to participate in the study
  • Establishment of a psychomotor follow-up between the time of the medical consultation and the psychomotor evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Psychomotor/psychological evaluation
Children in the study aged 6 to 30 months followed or referred to CHIC for oral disorders will have a psychomotor assessment and a psychological interview. Questionnaires on eating behavior will also be proposed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental Quotient
Time Frame: at day 1
Developmental Quotient at Brunet Lézine revised
at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quotient of development of the posturo-motor skills
Time Frame: 1 day
Quotient of development of the posturo-motor subcategory with revised Brunet Lézine
1 day
Development Quotient for the Brunet Lézine Coordination Subcategory
Time Frame: 1 day
Development Quotient for the Brunet Lézine Coordination Subcategory
1 day
Developmental Quotient for Brunet Lézine Language Subcategory
Time Frame: 1 day
Developmental Quotient for Brunet Lézine Language Subcategory
1 day
Development Quotient for the Brunet Lézine Socialization Subcategory
Time Frame: 1 day
Development Quotient for the Brunet Lézine Socialization Subcategory
1 day
tactile irritability
Time Frame: 1 day
Rating on the evaluation grid with tactile irritability
1 day
irritant irritability
Time Frame: 1 day
Scorecard score at irritant irritability
1 day
Observation of attachment
Time Frame: 1 day
Score at the grid observation of attachment lines before, during and after the separation of the child
1 day
Attachment with grandparent / parent
Time Frame: 1 day
Terms of Description of Grandparent / Parent and Parent / Child Attachment by Qualitative Analysis to Semi-directed Issues on Attachment
1 day
Food difficulty score child eating behavior questionnaire
Time Frame: 1 day
Food difficulty score child eating behavior questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Camille JUNG, MD, CHI Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2018

Primary Completion (Actual)

November 20, 2019

Study Completion (Actual)

November 20, 2019

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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