- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06665802
Avoidant and Restrictive Food Intake Disorders (ARFID) in Adolescence: Early Oral Development, Psychopathological Profile and Sensory Integration (ARFIDOS)
Study Overview
Status
Intervention / Treatment
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".
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Paris, France, 75019
- Hôpital Robert Debré
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Paris, France, 75015
- Hôpital Necker - Enfants Malades
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Paris, France, 75014
- Hopital Cochin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ARFID adolescents
Children between 12 and 17 years old diagnosed with ARFID less than 2 years prior
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Questionnaire completion
|
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Non ARFID adolescents
Children between 12 and 17 years old with no organic or psychological illness diagnosed
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Questionnaire completion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of pediatric feeding disorders (PFD)
Time Frame: 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of eating disorders on growth consequences in ARFID adolescents
Time Frame: 1 day
|
Evaluation of growth effects of ARFID by measuring the Z score and Tanner stage.
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1 day
|
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Sensory profile in ARFID adolescents
Time Frame: 1 day
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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)
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1 day
|
|
Anxiety in ARFID adolescents
Time Frame: 1 day
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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)
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1 day
|
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Depression in ARFID adolescents
Time Frame: 1 day
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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)
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1 day
|
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Autistic traits in ARFID adolescents
Time Frame: 1 day
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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)
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1 day
|
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Parental profile in ARFID adolescents
Time Frame: 1 day
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Compare parent's emotional expression for adolescents recently diagnosed with ARFID to adolescents without ARFID by using the five minute speech sample.
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1 day
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Autism Spectrum Disorder
- Mental Disorders
- Signs and Symptoms, Digestive
- Behavioral Symptoms
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Avoidant Restrictive Food Intake Disorder
- Anxiety Disorders
- Depression
- Autistic Disorder
- Feeding and Eating Disorders
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- APHP240861
- 2024-A01593-44 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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