Department of Pediatry, Necker-Enfants Malades Hospital
Paris, 75015, France
NCT Number: NCT04133038
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.
Looking for future studies?
Notify Me9 month–6 year
All sexes
Observational
Paris, 75015, France
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:
They want to test the statistical significance of the score. For that, they will test:
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Time frame: 1 month
Metrological qualities including the face validity, the structure validity and, the internal consistency and the interconcept validity of ORALQUEST.
Time frame: 1 day
ORALQUEST global score in each of the 8 cohorts of children
Time frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
Time frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
Time frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
Time frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
Assistance Publique - Hôpitaux de Paris
Other
Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST
Acronym: ORALQUEST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07153549
Anorexia, Appetite Disorders
Haiphong, Hai Phong, Vietnam
View Trial DetailsNCT04850794
Feeding and Eating Disorders, Feeding and Eating Disorders of Childhood
Chapel Hill, North Carolina, United States
View Trial DetailsNCT04301180
Feeding and Eating Disorders, Feeding and Eating Disorders of Childhood
Pozuelo de Alarcón, Madrid, Spain
View Trial DetailsNCT00635453
Behavior, Breast Feeding
Porto Alegre, Rio Grande do Sul, Brazil
View Trial Details