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

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ClinicalTrials.gov Identifier: NCT03671551
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Camille JUNG, Centre Hospitalier Intercommunal Creteil

Brief Summary:
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.

Condition or disease
Eating Disorders in Children Psychomotor Development Impaired

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Developmental Quotient [ Time Frame: at day 1 ]
    Developmental Quotient at Brunet Lézine revised


Secondary Outcome Measures :
  1. Quotient of development of the posturo-motor skills [ Time Frame: 1 day ]
    Quotient of development of the posturo-motor subcategory with revised Brunet Lézine

  2. Development Quotient for the Brunet Lézine Coordination Subcategory [ Time Frame: 1 day ]
    Development Quotient for the Brunet Lézine Coordination Subcategory

  3. Developmental Quotient for Brunet Lézine Language Subcategory [ Time Frame: 1 day ]
    Developmental Quotient for Brunet Lézine Language Subcategory

  4. Development Quotient for the Brunet Lézine Socialization Subcategory [ Time Frame: 1 day ]
    Development Quotient for the Brunet Lézine Socialization Subcategory

  5. tactile irritability [ Time Frame: 1 day ]
    Rating on the evaluation grid with tactile irritability

  6. irritant irritability [ Time Frame: 1 day ]
    Scorecard score at irritant irritability

  7. Observation of attachment [ Time Frame: 1 day ]
    Score at the grid observation of attachment lines before, during and after the separation of the child

  8. 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

  9. Food difficulty score child eating behavior questionnaire [ Time Frame: 1 day ]
    Food difficulty score child eating behavior questionnaire



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Ages Eligible for Study:   6 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671551


Contacts
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Contact: Elise NOUVIAN +33145175000 elise.nouvian@chicreteil.fr

Locations
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France
CHI Créteil Not yet recruiting
Créteil, Ile De France, France, 94000
Contact: Elise Nouvian       elise.nouvian@chicreteil.fr   
Contact: Maxime Brussieux       m.brussieux.chic@gmail.com   
Principal Investigator: Elise Nouvian         
CHI Creteil Recruiting
Créteil, France, 94000
Contact: Maxime Brussieux       m.brussieux.chic@gmail.com   
Principal Investigator: Camille Jung, MD         
Sponsors and Collaborators
Camille JUNG
Investigators
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Principal Investigator: Camille JUNG, MD CHI Créteil

Publications:

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Responsible Party: Camille JUNG, Head of the clinical research department, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03671551     History of Changes
Other Study ID Numbers: TODEVA
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Camille JUNG, Centre Hospitalier Intercommunal Creteil:
Eating Disorders in Children
Psychomotor Development Impaired

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Mouth Diseases
Pathologic Processes
Mental Disorders
Stomatognathic Diseases