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Eating Disorders in ChildrenTODEVANCT03671551

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

An observational study of Eating Disorders in Children and Psychomotor Development Impaired, run by Camille JUNG at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 30 months
Type of treatment
Pill or oral medicine
How many people
1 participants
Where
2 sitesFrance
Study dates
19 Nov 2018to 20 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 30 months
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHI Creteil

    Créteil, 94000

  • CHI Créteil

    Créteil, Île-de-France Region, 94000

Other trials in France

About this study

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.

Keywords
Eating Disorders in Children, Psychomotor Development Impaired

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03671551
Study groupRoleWhat they receive
Psychomotor/psychological evaluationChildren 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Developmental Quotient

    Developmental Quotient at Brunet Lézine revised

    Measured: at day 1

Secondary outcomes (9)

  1. Quotient of development of the posturo-motor skills

    Quotient of development of the posturo-motor subcategory with revised Brunet Lézine

    Measured: 1 day

  2. Development Quotient for the Brunet Lézine Coordination Subcategory

    Development Quotient for the Brunet Lézine Coordination Subcategory

    Measured: 1 day

  3. Developmental Quotient for Brunet Lézine Language Subcategory

    Developmental Quotient for Brunet Lézine Language Subcategory

    Measured: 1 day

  4. Development Quotient for the Brunet Lézine Socialization Subcategory

    Development Quotient for the Brunet Lézine Socialization Subcategory

    Measured: 1 day

  5. tactile irritability

    Rating on the evaluation grid with tactile irritability

    Measured: 1 day

  6. irritant irritability

    Scorecard score at irritant irritability

    Measured: 1 day

  7. Observation of attachment

    Score at the grid observation of attachment lines before, during and after the separation of the child

    Measured: 1 day

  8. Attachment with grandparent / parent

    Terms of Description of Grandparent / Parent and Parent / Child Attachment by Qualitative Analysis to Semi-directed Issues on Attachment

    Measured: 1 day

  9. Food difficulty score child eating behavior questionnaire

    Food difficulty score child eating behavior questionnaire

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start19 Nov 2018
  3. Primary completion20 Nov 2019
  4. Study completion20 Nov 2019

Why it stopped: Recruitment too low

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671551
Sponsor's protocol ID
TODEVA
Acronym
TODEVA
Status last verified
Nov 2019
First submitted
8 Aug 2018
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21495054

  • 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.

    PubMed 25644130

  • 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.

    PubMed 27133367

  • 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.

    PubMed 25560449

  • 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.

    PubMed 21683562

  • 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.

    PubMed 20654855

  • 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.

    PubMed 26459321

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Disorders in Children and Psychomotor Development Impaired, run by Camille JUNG at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment too low). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Developmental Quotient (time frame: at day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671551, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.

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