Evaluation of ORALQUEST (ORALQUEST)

October 10, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Paris, France, 75015
        • Recruiting
        • Department of Pediatry, Necker-Enfants Malades Hospital
        • Contact:
        • Sub-Investigator:
          • Béatrice THOUVENIN, psychologist

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

5 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged 9 months to 6 years with or without a congenital disease with a phobic and selective eating behaviour.

Description

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

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
Intervention / Treatment
Children consulting
Children consulting in the expert center for food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Pierre Robin sequence
Children with Pierre Robin sequence following for food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Cardiac malformations
Children with cardiac malformations followed for food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Oesophageal atresia
Children with oesophageal atresia followed for food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Cleft lip and palate
Children with cleft lip and palate followed for food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Autism spectrum disorders
Children followed for congenital pathology that cause food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Ex-prematurity < 32 AG
Children born premature followed for food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
Chromosomal anomalies
Children with chromosomal anomalies followed for food difficulties.
Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of ORALQUEST questionnaire
Time Frame: 1 month
Metrological qualities including the face validity, the structure validity and, the internal consistency and the interconcept validity of ORALQUEST.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORALQUEST global score
Time Frame: 1 day
ORALQUEST global score in each of the 8 cohorts of children
1 day
Behaviour during the meal ORALQUEST Sub-score
Time Frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
1 day
Oromotor skills ORALQUEST Sub-score
Time Frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
1 day
Sensory sensitivity ORALQUEST Sub-score
Time Frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
1 day
Familial environment ORALQUEST Sub-score
Time Frame: 1 day
ORALQUEST sub-score in each of the 8 cohorts of children
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Véronique ABADIE, MD, PhD, Assistance Publique - Hôpitaux de Paris

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)

March 3, 2020

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • APHP190790
  • 2019-A01215-52 (Registry Identifier: ID-RCB)

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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