Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (ODYSSED)

Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (Orality Dysensoriality and Eating Disorder)

This study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group.

Study Overview

Detailed Description

Eating disorders are a frequent reason for consultation in pediatrics at all ages.

When they are small, children may have an orality disorder. There are multiple potential causes for this disorder: psychogenic, oropraxic but also sensory. The treatment is then adapted to the patient, with, among other things, an orientation towards professionals trained in sensory disorders.

As they grow up, adolescents are particularly at risk of developing eating disorders, which are pathologies that correspond to a biopsychosocial model of understanding that includes psychogenetic, neuroendocrine and immune factors.

Despite major advances in the understanding of this disease, the sensory dimension for these patients is still little studied and is not taken into account in the treatment proposed to adolescents suffering from eating disorders.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

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

Study Locations

    • IDF
      • Paris, IDF, France, 75014
        • Maison de Solenn Maison des Adolescents, Cochin Hospital

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

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants were all recruited at the Maison de Solenn, Cochin - Paris, a service specialized in the treatment of eating disorders for adolescents. The participants in the control group are patients followed in this center for another reason than an eating disorder. The participants were recruited in consultation, in day hospital or in complete hospitalization.

Description

Inclusion Criteria:

  • Adolescent between 12 to 18 years old.
  • Non-opposition of the adolescent and his or her legal guardians collected before the start of the study.
  • Patient group: Diagnosis of restrictive eating disorders (Anorexia Nervosa typical or atypical, ARFID) meeting DSM-5 criteria.
  • Control group: absence of eating disorders.

Exclusion Criteria:

  • Eating disorders secondary to another psychiatric pathology.
  • Precarious health status with somatic and/or psychiatric instability that does not allow to answer the questionnaire.
  • Language barrier.
  • Opposition of the adolescent and/or his/her legal representatives obtained before the start of the study
  • Patient under " AME " (medical state help)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Restrictive eating disorder group
Adolescents between 12 and 18 y.o. Restrictive eating disorders diagnosis (Anorexia Nervosa or ARFID) answering DSM-5 criteria
The Sensory Processing Scale Inventory (SPSI) is the main questionnaire. It allows to define over and under sensitive profiles. It's a self-administrated questionnaire

The ASSQ allows to detect autism spectrum disorders (ASD). This quotient is proposed to the group because the investigators know that ASD are often correlated with sensory integration disorders.

It's answered by the participant's parents.

The GAD7 questionnaire allows to detect anxiety disorder. This questionnaire is proposed to the group because the investigators know that anxiety disorders are often correlated with sensory integration disorders.

It's a self-administrated questionnaire.

The Conners abridged questionnaire allows to detect attention-deficit hyperactivity disorder (ADHD). This questionnaire is proposed to the group because the investigators know that ADHD are often correlated with sensory integration disorders.

The questionnaire is answered by the participant's parents.

The EAT 26 questionnaire allows to detect anorexia nervosa. It is proposed to the patient with an eating disorder to establish the level of severity of their disease.

It's a self-administrated questionnaire.

Control group
Adolescents between 12 and 18 y.o. No eating disorders
The Sensory Processing Scale Inventory (SPSI) is the main questionnaire. It allows to define over and under sensitive profiles. It's a self-administrated questionnaire

The ASSQ allows to detect autism spectrum disorders (ASD). This quotient is proposed to the group because the investigators know that ASD are often correlated with sensory integration disorders.

It's answered by the participant's parents.

The GAD7 questionnaire allows to detect anxiety disorder. This questionnaire is proposed to the group because the investigators know that anxiety disorders are often correlated with sensory integration disorders.

It's a self-administrated questionnaire.

The Conners abridged questionnaire allows to detect attention-deficit hyperactivity disorder (ADHD). This questionnaire is proposed to the group because the investigators know that ADHD are often correlated with sensory integration disorders.

The questionnaire is answered by the participant's parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Sensory Processing Scale Inventory (SPSI) scores between the two groups
Time Frame: Inclusion

Comparison of average Sensory Processing Scale Inventory (SPSI) scores between the two groups This questionnaire focuses on sensoriality. It allows the definition of over or under-reactive sensory profiles. It is made of two lists (list #1 : 73 items ; list #2 : 29 items).

The SPSI questionnaire is in English. For this reason, a group of experts from La Maison de Solenn met to translate it into French being as faithful as possible to the original questionnaire. Each checklist has its own score, the result is the sum of the points obtained (one point for YES, zero points for NO) (6).

Two groups will be formed: a group with eating disorders and a control group. The questionnaire will be answered only once and will be proposed to the participant at the end of a consultation at the Maison de Solenn for his usual follow-up or during a hospitalization (full time hospitalization or in day hospital).

Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening for pathologies known to be associated with a sensory disorder
Time Frame: Inclusion
Screening questionnaires for Autism Spectrum Disorder (ASD) will be distributed in order to identify disorders associated with a particular sensory profile. This will allow statistical results to be refined by performing multivariate analyses.
Inclusion
Screening for pathologies known to be associated with a sensory disorder
Time Frame: Inclusion
Screening questionnaires for Attention Deficit Hyperactivity Disorder (ADHD) will be distributed in order to identify disorders associated with a particular sensory profile. This will allow statistical results to be refined by performing multivariate analyses.
Inclusion
Screening for pathologies known to be associated with a sensory disorder
Time Frame: Inclusion
Screening questionnaires for Generalized Anxiety Disorder (GAD) will be distributed in order to identify disorders associated with a particular sensory profile. This will allow statistical results to be refined by performing multivariate analyses.
Inclusion
Search for a link between the eating disorders severity and sensory disorders
Time Frame: Inclusion

The EAT 26 questionnaire is used to measure the severity of an eating disorder. It will be proposed only to the participants of the eating disorder group.

This measure of severity will assess whether there is a relationship between the severity of the ED and the severity of the sensory disorders.

Inclusion

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Corinne BLANCHET, APHP - Cochin hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

November 30, 2021

Primary Completion (ACTUAL)

March 24, 2022

Study Completion (ACTUAL)

March 24, 2022

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (ACTUAL)

October 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

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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