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Evaluation of ORALQUEST

Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04133038
Acronym
ORALQUEST
Enrollment
338
Registered
2019-10-21
Start date
2020-03-03
Completion date
2023-07-28
Last updated
2026-08-25

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

Conditions

Feeding and Eating Disorders of Childhood

Keywords

Feeding disorders, Eating disorders, Evaluation

Brief summary

Feeding and eating disorders are frequent in children of the general population. They are much more frequent in children with congenital chronic diseases. The analysis of feeding and eating disorders in children is difficult since their causes are complex and multiple. In addition to the clinical examination and the instrumental investigation, a parental questionnaire is very useful in assessing these disorders. The questionnaire (testing the right period of age, evaluating the 4 aspects involved in the disorders, translated in French) does not exist. Consequently, the Necker team of the reference center, has built a hetero-questionnaire named ORALQUEST, which analyses 4 dimensions of the feeding and eating disorders of young children from 9 months to 6 years: behaviour, oral motor skills, sensory sensitivity and familial environment. The objective of the study is to test the metrological qualities of Oralquest in children with congenital chronic diseases including feeding and eating disorders. The questionnaire will be proposed to 7 cohorts of children who are followed in Necker for : * oesophageal atresia, * cardiac malformations, * Pierre Robin sequence, * cleft lip and palate, * autism spectrum disorders, * ex-prematurity \< 32 AG, * chromosomal anomalies, and proposed to children consulting in the expert center for phobic and selective eating behaviour. The analysis of the metrological qualities of the questionnaire include several calculation and specialized methods: inter-rate concordance; test-retest; intrinsic validity, concurrent validity, sensitivity/specificity.

Detailed description

Objectives of the study To analyse the properties of a new scale that evaluates feeding and eating disorders of young children. This scale is a hetero-questionnaire that was build by an expert team. It includes 46 questions scored with a Likert scale. These questions identify 4 fields: behaviour during the meal, oromotor skills, sensory sensitivity and familial environment. Each field gives a sub-score, their addition gives a global score Methods To evaluate the metrological qualities of this questionnaire, the investigators are going to investigate 300 children followed-up in Necker for either Aversive/restrictive food intake disorders (ARFID) or for chronic congenital disease very often complicated with feeding and eating disorders: * oesophageal atresia, * cardiac malformations, * Pierre Robin sequence, * cleft lip and palate, * autism spectrum disorders, * ex-prematurity \< 32 AG, * chromosomal anomalies, They want to test the statistical significance of the score. For that, they will test: * the face validity, * the structure validity * and, the internal consistence of Oralquest. The interconcept validity will be analysed by comparing the Oralquest results to the best gold standard tests that are found for each field tested by Oralquest. For the global score : The screening test : self-questionnaire, the Montreal Children Feeding Scale. For the behavior score : the symptom check list (items regarding eating). For the oromotor skills : (Schedule for Oral-Motor Assessment) for the children aged 9-24 months and the Oral-Motor Assessment Scale for the children aged 2-6 years). For the familial environment : The STAI (State Trait Anxiety Inventory). The reproductibility will be tested by : * Test-retest * Inter examiner reproductibility * sensibility * specificity

Interventions

OTHERQuestionnaire

Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Filiere de Sante Maladies Rares TETECOU
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Months to 6 Years
Healthy volunteers
No

Inclusion criteria

\- child of 9 months to 6 years old: * Consulting for food difficulties in the expert center for phobic and selective eating behaviour of Necker-Enfants malades hospital or * Followed to Necker-Enfants Malades hospital for one of 7 chronic congenital pathologies: oesophageal atresia, cardiac malformations, Pierre Robin sequence, cleft lip and palate, autism spectrum disorders, ex-prematurity \< 32 AG, chromosomal anomalies

Exclusion criteria

\- parent (s) with a low level of French to understand the questions

Design outcomes

Primary

MeasureTime frameDescription
Validity of ORALQUEST questionnaire1 monthMetrological qualities including the face validity, the structure validity and, the internal consistency and the interconcept validity of ORALQUEST.

Secondary

MeasureTime frameDescription
ORALQUEST global score1 dayORALQUEST global score in each of the 8 cohorts of children
Behaviour during the meal ORALQUEST Sub-score1 dayORALQUEST sub-score in each of the 8 cohorts of children
Oromotor skills ORALQUEST Sub-score1 dayORALQUEST sub-score in each of the 8 cohorts of children
Sensory sensitivity ORALQUEST Sub-score1 dayORALQUEST sub-score in each of the 8 cohorts of children
Familial environment ORALQUEST Sub-score1 dayORALQUEST sub-score in each of the 8 cohorts of children

Countries

France

Contacts

PRINCIPAL_INVESTIGATORVéronique ABADIE, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026