Evaluation of ORALQUEST

Feeding and Eating Disorders of Childhood Clinical Trial

— ORALQUEST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04133038
• Other study ID #: APHP190790
• Secondary ID: 2019-A01215-52
• Status: Recruiting
• Start date: March 3, 2020
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Véronique ABADIE, MD, PhD
• Phone: +33 (0)1 44 49 52 11
• Email: veronique.abadie[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding and Eating Disorders of Childhood

Intervention

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

Locations

Country	Name	City	State
France	Department of Pediatry, Necker-Enfants Malades Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Filiere de Sante Maladies Rares TETECOU, URC-CIC Paris Descartes Necker Cochin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of ORALQUEST questionnaire	Metrological qualities including the face validity, the structure validity and, the internal consistency and the interconcept validity of ORALQUEST.	1 month
Secondary	ORALQUEST global score	ORALQUEST global score in each of the 8 cohorts of children	1 day
Secondary	Behaviour during the meal ORALQUEST Sub-score	ORALQUEST sub-score in each of the 8 cohorts of children	1 day
Secondary	Oromotor skills ORALQUEST Sub-score	ORALQUEST sub-score in each of the 8 cohorts of children	1 day
Secondary	Sensory sensitivity ORALQUEST Sub-score	ORALQUEST sub-score in each of the 8 cohorts of children	1 day
Secondary	Familial environment ORALQUEST Sub-score	ORALQUEST sub-score in each of the 8 cohorts of children	1 day