Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality

Eating Disorders in Adolescence Clinical Trial

— ODYSSED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091983
• Other study ID #: APHP211140
• Secondary ID: 2021-A01755-36
• Status: Completed
• Start date: November 30, 2021
• Est. completion date: March 24, 2022

Study information

• Verified date: June 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Eating Disorders in Adolescence
• Feeding and Eating Disorders

Intervention

Other:
• Sensory Processing Scale Inventory (SPSI)
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
• Autism Spectrum Screening Quotient (ASSQ)
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.
• GAD 7
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.
• Conners abridged
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.
• EAT 26
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.

Locations

Country	Name	City	State
France	Maison de Solenn Maison des Adolescents, Cochin Hospital	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. — View Citation

Gorwood P, Blanchet-Collet C, Chartrel N, Duclos J, Dechelotte P, Hanachi M, Fetissov S, Godart N, Melchior JC, Ramoz N, Rovere-Jovene C, Tolle V, Viltart O, Epelbaum J. New Insights in Anorexia Nervosa. Front Neurosci. 2016 Jun 29;10:256. doi: 10.3389/fnins.2016.00256. eCollection 2016. Review. — View Citation

Schoen SA, Miller LJ, Green KE. Pilot study of the Sensory Over-Responsivity Scales: assessment and inventory. Am J Occup Ther. 2008 Jul-Aug;62(4):393-406. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Sensory Processing Scale Inventory (SPSI) scores between the two groups	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	Screening for pathologies known to be associated with a sensory disorder	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
Secondary	Screening for pathologies known to be associated with a sensory disorder	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
Secondary	Screening for pathologies known to be associated with a sensory disorder	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
Secondary	Search for a link between the eating disorders severity and sensory disorders	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

External Links

•   LEBLANC V, LECOUFLE A, BOURGEOIS C, al et. Boîte à idées pour oralité malmenée du jeune enfant [Internet]. Nutricia; s. d. 19 p