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Avoidant and Restrictive Food Intake DisordersARFIDOSNCT06665802

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

An observational study of Avoidant and Restrictive Food Intake Disorders, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
What is being tested?
Questionnaire
How many people
60 participants
Where
3 sitesFrance
Study dates
3 Feb 2025to 2 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Adolescents diagnosed with ARFID less than 2 years before

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

France3 sites

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Necker - Enfants malades

    Paris, 75015

  • Hôpital Robert Debré

    Paris, 75019

Other trials in France

About this study

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.

Read the detailed description

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".

Being tested
Questionnaire
Keywords
Avoidant and Restrictive Food Intake Disorders, ARFID, Eating disorder, Adolescent, Depression, Autism, Anxiety, Sensory sensitivity
Medical subject headings
Avoidant Restrictive Food Intake Disorder, Feeding and Eating Disorders, Depression, Autistic Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireBehavioural

    Questionnaire completion

Study groups in NCT06665802
Study groupRoleWhat they receive
ARFID adolescentsChildren between 12 and 17 years old diagnosed with ARFID less than 2 years prior
Receives: Behavioral: Questionnaire
Non ARFID adolescentsChildren between 12 and 17 years old with no organic or psychological illness diagnosed
Receives: Behavioral: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of pediatric feeding disorders (PFD)

    Determine whether adolescents recently diagnosed with ARFID have more frequent FPD before the age of 4 years compared to adolescents without ARFID by using the Montreal scale score (61 or more) and/or the specific study questionnaire (at least 4 positive answers)

    Measured: 1 day

Secondary outcomes (6)

  1. Severity of eating disorders on growth consequences in ARFID adolescents

    Evaluation of growth effects of ARFID by measuring the Z score and Tanner stage.

    Measured: 1 day

  2. Sensory profile in ARFID adolescents

    Determine whether adolescents recently diagnosed with ARFID have more frequent hypersensoring or hyposensoring traits compared to adolescents without ARFID by using Sensoring Processing Scale Inventory (SPSI)

    Measured: 1 day

  3. Anxiety in ARFID adolescents

    Determine whether adolescents recently diagnosed with ARFID have more frequent anxiety compared to adolescents without ARFID by using the GAD-7 scale (score of 5 or more)

    Measured: 1 day

  4. Depression in ARFID adolescents

    Determine whether adolescents recently diagnosed with ARFID have more frequent depression compared to adolescents without ARFID by using the ADRS (Adolescent Depression Rating Sclale) (score of 4 or more)

    Measured: 1 day

  5. Autistic traits in ARFID adolescents

    Determine whether adolescents recently diagnosed with ARFID have more frequent autistic traits compared to adolescents without ARFID by using the Autism Spectrum Screening Questionnaire (ASSQ) (score of 13 or more)

    Measured: 1 day

  6. Parental profile in ARFID adolescents

    Compare parent's emotional expression for adolescents recently diagnosed with ARFID to adolescents without ARFID by using the five minute speech sample.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2024
  2. Study start3 Feb 2025
  3. Primary completion3 Feb 2025
  4. Study completion2 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06665802
Sponsor's protocol ID
APHP240861
Other IDs
2024-A01593-44
Acronym
ARFIDOS
Status last verified
Apr 2026
First submitted
24 Oct 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abadie V. [Diagnostic approach in oral disorder in young children]. Arch Pediatr. 2004 Jun;11(6):603-5. doi: 10.1016/j.arcped.2004.03.040. No abstract available. French.

    PubMed 15158850

  • Rein Z, Perdereau F, Curt F, Jeammet P, Fermanian J, Godart N. Expressed emotion and anorexia nervosa: the validation of the Five-Minute Speech Sample in reference to the Camberwell Family Interview. Int J Eat Disord. 2006 Apr;39(3):217-23. doi: 10.1002/eat.20245.

    PubMed 16511834

  • Goday PS, Huh SY, Silverman A, Lukens CT, Dodrill P, Cohen SS, Delaney AL, Feuling MB, Noel RJ, Gisel E, Kenzer A, Kessler DB, Kraus de Camargo O, Browne J, Phalen JA. Pediatric Feeding Disorder: Consensus Definition and Conceptual Framework. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):124-129. doi: 10.1097/MPG.0000000000002188.

    PubMed 30358739

  • Fisher MM, Rosen DS, Ornstein RM, Mammel KA, Katzman DK, Rome ES, Callahan ST, Malizio J, Kearney S, Walsh BT. Characteristics of avoidant/restrictive food intake disorder in children and adolescents: a "new disorder" in DSM-5. J Adolesc Health. 2014 Jul;55(1):49-52. doi: 10.1016/j.jadohealth.2013.11.013. Epub 2014 Feb 5.

    PubMed 24506978

  • Diagnosis and Statistical Manual of Mental Disorders: DSM-5. 5th ed. Washington, DC, USA: American Psychiatric Association (2013).

  • Monteleone P, Di Genio M, Monteleone AM, Di Filippo C, Maj M. Investigation of factors associated to crossover from anorexia nervosa restricting type (ANR) and anorexia nervosa binge-purging type (ANBP) to bulimia nervosa and comparison of bulimia nervosa patients with or without previous ANR or ANBP. Compr Psychiatry. 2011 Jan-Feb;52(1):56-62. doi: 10.1016/j.comppsych.2010.05.002. Epub 2010 Jul 1.

    PubMed 21220066

  • Galmiche M, Dechelotte P, Lambert G, Tavolacci MP. Prevalence of eating disorders over the 2000-2018 period: a systematic literature review. Am J Clin Nutr. 2019 May 1;109(5):1402-1413. doi: 10.1093/ajcn/nqy342.

    PubMed 31051507

Questions about this trial

What is this clinical trial studying?

An observational study of Avoidant and Restrictive Food Intake Disorders, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of pediatric feeding disorders (PFD) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06665802, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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