- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04133038
Evaluation of ORALQUEST (ORALQUEST)
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
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Véronique ABADIE, MD, PhD
- Phone Number: +33 (0)1 44 49 52 11
- Email: veronique.abadie@aphp.fr
Study Locations
-
-
-
Paris, France, 75015
- Recruiting
- Department of Pediatry, Necker-Enfants Malades Hospital
-
Contact:
- Véronique ABADIE, MD, PhD
- Phone Number: +33 (0)1 44 49 52 11
- Email: veronique.abadie@aphp.fr
-
Sub-Investigator:
- Béatrice THOUVENIN, psychologist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Véronique ABADIE, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Feeding and Eating Disorders of Childhood
-
Children's Mercy Hospital Kansas CityThe Gerber FoundationEnrolling by invitationFeeding and Eating Disorders of Childhood | Gastrostomy | Feeding Disorder of Infancy and ChildhoodUnited States
-
Meyer Children's Hospital IRCCSActive, not recruitingFeeding and Eating Disorders of ChildhoodItaly
-
Benny Kerzner, MDAbbott NutritionWithdrawnFeeding and Eating Disorders of Childhood | Feeding DifficultiesUnited States
-
Kelly TannerCompleted
-
Emory UniversityCompletedFeeding and Eating Disorders of ChildhoodUnited States
-
Universidad Francisco de VitoriaDavid Varillas Delgado; María Cristina Martincrespo-Blanco; Saray Blanco-Abril; María Gema Cid-Expósito and other collaboratorsCompleted
-
Federal University of Health Science of Porto AlegreMinistry of Health, Brazil; Fundação de Amparo à Pesquisa do Estado do Rio...CompletedFeeding and Eating Disorders of ChildhoodBrazil
-
Emory UniversityCompletedFeeding and Eating Disorders of ChildhoodUnited States
-
University of BristolMedical Research Council; Wellcome Trust; NestléCompletedFeeding and Eating Disorders of Childhood | Parent-Child Relations | Parenting | Child Behavior | Eating Behavior | Child Rearing
-
BeerYaakov Mental Health CenterUnknownFeeding and Eating Disorders of Childhood | Developmental DisabilitiesIsrael
Clinical Trials on Questionnaire
-
H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaCompletedAnxiety | Psychological StressUnited States
-
Centre Hospitalier Universitaire de NiceCompletedGeneral Population | TDAH | Children Aged 5 to 18 YearsFrance
-
Imperial College LondonRoyal Marsden NHS Foundation Trust; University College London Hospitals; The... and other collaboratorsCompleted
-
Minneapolis Veterans Affairs Medical CenterUnited States Department of DefenseCompletedLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury)United States
-
Stanford UniversityRecruitingAstigmatism | Nearsightedness | FarsightednessUnited States
-
NSABP Foundation IncNational Cancer Institute (NCI)Completed
-
University of LiegeCompletedCritical Illness | Covid19 | Psychological Stress | FamilyBelgium
-
Rabin Medical CenterCompleted
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
National Taiwan University HospitalNational Taiwan UniversityUnknownComputerized Physician Order EntryTaiwan