NCT05091983

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 27, 2021

Last Update Submit

September 5, 2025

Conditions

Keywords

Restrictive eating disorderanorexia nervosaAvoidant/Restrictive Food Intake Disordersensory modulation disordersensory modulation symptomssensory over responsivitysensory integration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Screening for pathologies known to be associated with a sensory disorder

    Inclusion

  • Screening for pathologies known to be associated with a sensory disorder

    Inclusion

  • Screening for pathologies known to be associated with a sensory disorder

    Inclusion

  • Search for a link between the eating disorders severity and sensory disorders

    Inclusion

Study Arms (2)

Restrictive eating disorder group

Adolescents between 12 and 18 y.o. Restrictive eating disorders diagnosis (Anorexia Nervosa or ARFID) answering DSM-5 criteria

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

Control group

Adolescents between 12 and 18 y.o. No eating disorders

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

Interventions

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

Control groupRestrictive eating disorder group

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.

Control groupRestrictive eating disorder group
GAD 7OTHER

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.

Control groupRestrictive eating disorder group

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.

Control groupRestrictive eating disorder group
EAT 26OTHER

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.

Restrictive eating disorder group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison de Solenn Maison des Adolescents, Cochin Hospital

Paris, IDF, 75014, France

Location

Related Publications (3)

  • Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.

    PMID: 24413388BACKGROUND
  • 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.

    PMID: 27445651BACKGROUND
  • 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. doi: 10.5014/ajot.62.4.393.

    PMID: 18712002BACKGROUND

Related Links

MeSH Terms

Conditions

Avoidant Restrictive Food Intake DisorderAnorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Corinne BLANCHET

    APHP - Cochin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 25, 2021

Study Start

November 30, 2021

Primary Completion

March 24, 2022

Study Completion

March 24, 2022

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations