- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03671551
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
Status
Terminated
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
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Créteil, France, 94000
- CHI Creteil
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Ile De France
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Créteil, Ile De France, France, 94000
- CHI Creteil
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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 |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developmental Quotient
Time Frame: at day 1
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Developmental Quotient at Brunet Lézine revised
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at day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quotient of development of the posturo-motor skills
Time Frame: 1 day
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Quotient of development of the posturo-motor subcategory with revised Brunet Lézine
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1 day
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Development Quotient for the Brunet Lézine Coordination Subcategory
Time Frame: 1 day
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Development Quotient for the Brunet Lézine Coordination Subcategory
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1 day
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Developmental Quotient for Brunet Lézine Language Subcategory
Time Frame: 1 day
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Developmental Quotient for Brunet Lézine Language Subcategory
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1 day
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Development Quotient for the Brunet Lézine Socialization Subcategory
Time Frame: 1 day
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Development Quotient for the Brunet Lézine Socialization Subcategory
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1 day
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tactile irritability
Time Frame: 1 day
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Rating on the evaluation grid with tactile irritability
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1 day
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irritant irritability
Time Frame: 1 day
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Scorecard score at irritant irritability
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1 day
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Observation of attachment
Time Frame: 1 day
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Score at the grid observation of attachment lines before, during and after the separation of the child
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1 day
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Attachment with grandparent / parent
Time Frame: 1 day
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Terms of Description of Grandparent / Parent and Parent / Child Attachment by Qualitative Analysis to Semi-directed Issues on Attachment
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1 day
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Food difficulty score child eating behavior questionnaire
Time Frame: 1 day
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Food difficulty score child eating behavior questionnaire
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1 day
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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
- Ammaniti M, Lucarelli L, Cimino S, D'Olimpio F, Chatoor I. Feeding disorders of infancy: a longitudinal study to middle childhood. Int J Eat Disord. 2012 Mar;45(2):272-80. doi: 10.1002/eat.20925. Epub 2011 Apr 14.
- Cardona Cano S, Tiemeier H, Van Hoeken D, Tharner A, Jaddoe VW, Hofman A, Verhulst FC, Hoek HW. Trajectories of picky eating during childhood: A general population study. Int J Eat Disord. 2015 Sep;48(6):570-9. doi: 10.1002/eat.22384. Epub 2015 Jan 30.
- Dubedout S, Cascales T, Mas E, Bion A, Vignes M, Raynaud JP, Olives JP. [Feeding disorders in infants and toddlers: At-risk situations and predisposing factors]. Arch Pediatr. 2016 Jun;23(6):570-6. doi: 10.1016/j.arcped.2016.03.015. Epub 2016 Apr 25. French.
- Kerzner B, Milano K, MacLean WC Jr, Berall G, Stuart S, Chatoor I. A practical approach to classifying and managing feeding difficulties. Pediatrics. 2015 Feb;135(2):344-53. doi: 10.1542/peds.2014-1630. Epub 2015 Jan 5.
- Le Heuzey MF. [Child food refusal: when will we call a child psychiatrist?]. Arch Pediatr. 2011 Aug;18(8):917-20. doi: 10.1016/j.arcped.2011.05.014. Epub 2011 Jun 16. French.
- Issanchou S, Nicklaus S. [Early determinants of food behaviour]. Arch Pediatr. 2010 Jun;17(6):713-4. doi: 10.1016/S0929-693X(10)70073-7. No abstract available. French.
- Quah PL, Chan YH, Aris IM, Pang WW, Toh JY, Tint MT, Broekman BF, Saw SM, Kwek K, Godfrey KM, Gluckman PD, Chong YS, Meaney MJ, Yap FK, van Dam RM, Lee YS, Chong MF; GUSTO Study Group. Prospective associations of appetitive traits at 3 and 12 months of age with body mass index and weight gain in the first 2 years of life. BMC Pediatr. 2015 Oct 12;15:153. doi: 10.1186/s12887-015-0467-8.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- TODEVA
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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