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Avoidant and Restrictive Food Intake Disorders (ARFID) in Adolescence: Early Oral Development, Psychopathological Profile and Sensory Integration

Study Purpose

The purpose of this study is to assess if adolescents affected with Avoidant and Restrictive Food Intake Disorders (ARFID) had more frequent precocious pediatric feeding disorders before 4 years old compared to healthy adolescents.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 12 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

For all patients:
  • - Adolescent aged 12 to 18 (minors = 17 years 11 months) - No opposition from parents and adolescent.
For ARFID patients:
  • - Consulting at MDA or Necker for an ARFID diagnosed using DSM V criteria.
  • - Whose first consultation for this disorder was less than 2 years ago.
For non-ARFID patients:
  • - Consulting or hospitalized in orthopaedic surgery at Necker Hospital or Robert Debré Hospital for an acute traumatic reason.
  • - Not diagnosed with a chronic illness.

Exclusion Criteria:

For all patients:
  • - Parents and adolescents who do not speak French well enough to understand the questions on the scales and questionnaires.
For ARFID patients:
  • - Diagnosis of autism spectrum disorder already made at the time of the consultation.
For non-ARFID patients: - Presence of a chronic organic or psychological illness, to limit the risk of including non ARFID patients at high risk of eating disorders

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06665802
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Avoidant and Restrictive Food Intake Disorders
Study Website: View Trial Website
Additional Details

This research focuses on retrospective analysis of early pediatric feeding disorders seen for ARFID in adolescence in two departments of the DMU MEFADO. This assessment will be implemented during a hospital visit by a questionnaire completed by the patient's parents covering the first years of the child's life in medical, behavioural and dietary terms. This questionnaire was created for this study and, therefore, is not validated for general population. The parents will also complete the Montreal Children Feeding scale based on their memories. The Montreal Children Feeding scale is a validated parental self-questionnaire, allowing the screening of feeding and eating disorders in children under 6 years old. Since the study specific questionnaire is not validated, 60 non-ARFID controls will be included in the study for questionnaires completion. The research also focuses on the psychopathological profile of these adolescents with ARFID regarding their degree of anxiety, their degree of depression, their possible autistic traits and their sensory sensitivity. These aspects will be studied by validated self- and hetero-questionnaires standardized for these fields. The emotional expression of the parents will be assessed during a brief qualitative interview type "Five-Minute Speech Sample".

Arms & Interventions

Arms

: ARFID adolescents

Children between 12 and 17 years old diagnosed with ARFID less than 2 years prior

: Non ARFID adolescents

Children between 12 and 17 years old with no organic or psychological illness diagnosed

Interventions

Behavioral: - Questionnaire

Questionnaire completion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hôpital Cochin, Paris, France

Status

Address

Hôpital Cochin

Paris, , 75014

Site Contact

Corinne BLANCHET, MD

[email protected]

01 58 41 24 26

Hôpital Necker - Enfants malades, Paris, France

Status

Address

Hôpital Necker - Enfants malades

Paris, , 75015

Site Contact

Véronique ABADIE, MD, PhD

[email protected]

01 58 41 24 26

Hôpital Robert Debré, Paris, France

Status

Address

Hôpital Robert Debré

Paris, , 75019

Site Contact

Anne-Laure SIMON, MD

[email protected]

01 58 41 24 26

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