NCT06665802

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

October 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

October 24, 2024

Last Update Submit

April 30, 2026

Conditions

Keywords

Avoidant and Restrictive Food Intake DisordersARFIDEating disorderAdolescentDepressionAutismAnxietySensory sensitivity

Outcome Measures

Primary Outcomes (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)

    1 day

Secondary Outcomes (6)

  • Severity of eating disorders on growth consequences in ARFID adolescents

    1 day

  • Sensory profile in ARFID adolescents

    1 day

  • Anxiety in ARFID adolescents

    1 day

  • Depression in ARFID adolescents

    1 day

  • Autistic traits in ARFID adolescents

    1 day

  • +1 more secondary outcomes

Study Arms (2)

ARFID adolescents

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

Behavioral: Questionnaire

Non ARFID adolescents

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

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaire completion

ARFID adolescentsNon ARFID adolescents

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Adolescents diagnosed with ARFID less than 2 years before

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Necker - Enfants malades

Paris, 75015, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (7)

  • 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.

    PMID: 15158850BACKGROUND
  • 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.

    PMID: 16511834BACKGROUND
  • 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.

    PMID: 30358739BACKGROUND
  • 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.

    PMID: 24506978BACKGROUND
  • Diagnosis and Statistical Manual of Mental Disorders: DSM-5. 5th ed. Washington, DC, USA: American Psychiatric Association (2013).

    BACKGROUND
  • 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.

    PMID: 21220066BACKGROUND
  • 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.

    PMID: 31051507BACKGROUND

Related Links

MeSH Terms

Conditions

Avoidant Restrictive Food Intake DisorderFeeding and Eating DisordersDepressionAutistic DisorderAnxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 30, 2024

Study Start

February 3, 2025

Primary Completion

February 3, 2025

Study Completion

May 2, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations