Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06665802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-30
First Post:
2024-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Avoidant and Restrictive Food Intake Disorders (ARFID) in Adolescence: Early Oral Development, Psychopathological Profile and Sensory Integration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080146', 'term': 'Avoidant Restrictive Food Intake Disorder'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of pediatric feeding disorders (PFD)', 'timeFrame': '1 day', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Severity of eating disorders on growth consequences in ARFID adolescents', 'timeFrame': '1 day', 'description': 'Evaluation of growth effects of ARFID by measuring the Z score and Tanner stage.'}, {'measure': 'Sensory profile in ARFID adolescents', 'timeFrame': '1 day', 'description': '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)'}, {'measure': 'Anxiety in ARFID adolescents', 'timeFrame': '1 day', 'description': '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)'}, {'measure': 'Depression in ARFID adolescents', 'timeFrame': '1 day', 'description': '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)'}, {'measure': 'Autistic traits in ARFID adolescents', 'timeFrame': '1 day', 'description': '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)'}, {'measure': 'Parental profile in ARFID adolescents', 'timeFrame': '1 day', 'description': "Compare parent's emotional expression for adolescents recently diagnosed with ARFID to adolescents without ARFID by using the five minute speech sample."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Avoidant and Restrictive Food Intake Disorders', 'ARFID', 'Eating disorder', 'Adolescent', 'Depression', 'Autism', 'Anxiety', 'Sensory sensitivity'], 'conditions': ['Avoidant and Restrictive Food Intake Disorders']}, 'referencesModule': {'references': [{'pmid': '15158850', 'type': 'BACKGROUND', 'citation': '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': '16511834', 'type': 'BACKGROUND', 'citation': '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': '30358739', 'type': 'BACKGROUND', 'citation': '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': '24506978', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Diagnosis and Statistical Manual of Mental Disorders: DSM-5. 5th ed. Washington, DC, USA: American Psychiatric Association (2013).'}, {'pmid': '21220066', 'type': 'BACKGROUND', 'citation': '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': '31051507', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://inforalite.fr', 'label': 'website for parents and professionals about pediatric feeding disorders'}, {'url': 'https://ffab.fr/', 'label': 'website about eating behaviour of adolescents especially anorexia and bulimia nervosa'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This research focuses on retrospective analysis of early pediatric feeding disorders seen for ARFID in adolescence in two departments of the DMU MEFADO.\n\nThis 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.\n\nThe 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".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents diagnosed with ARFID less than 2 years before', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all patients:\n\n* Adolescent aged 12 to 18 (minors = 17 years 11 months)\n* No opposition from parents and adolescent\n\nFor ARFID patients:\n\n* Consulting at MDA or Necker for an ARFID diagnosed using DSM V criteria\n* Whose first consultation for this disorder was less than 2 years ago\n\nFor non-ARFID patients:\n\n* Consulting or hospitalized in orthopaedic surgery at Necker Hospital or Robert Debré Hospital for an acute traumatic reason\n* Not diagnosed with a chronic illness\n\nExclusion Criteria:\n\nFor all patients:\n\n\\- Parents and adolescents who do not speak French well enough to understand the questions on the scales and questionnaires\n\nFor ARFID patients:\n\n\\- Diagnosis of autism spectrum disorder already made at the time of the consultation\n\nFor non-ARFID patients:\n\n\\- Presence of a chronic organic or psychological illness, to limit the risk of including non ARFID patients at high risk of eating disorders'}, 'identificationModule': {'nctId': 'NCT06665802', 'acronym': 'ARFIDOS', 'briefTitle': 'Avoidant and Restrictive Food Intake Disorders (ARFID) in Adolescence: Early Oral Development, Psychopathological Profile and Sensory Integration', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Avoidant and Restrictive Food Intake Disorders (ARFID) in Adolescence: Early Oral Development, Psychopathological Profile and Sensory Integration', 'orgStudyIdInfo': {'id': 'APHP240861'}, 'secondaryIdInfos': [{'id': '2024-A01593-44', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARFID adolescents', 'description': 'Children between 12 and 17 years old diagnosed with ARFID less than 2 years prior', 'interventionNames': ['Behavioral: Questionnaire']}, {'label': 'Non ARFID adolescents', 'description': 'Children between 12 and 17 years old with no organic or psychological illness diagnosed', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Questionnaire completion', 'armGroupLabels': ['ARFID adolescents', 'Non ARFID adolescents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Corinne BLANCHET, MD', 'role': 'CONTACT', 'email': 'corinne.blanchet@aphp.fr'}], 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Véronique ABADIE, MD, PhD', 'role': 'CONTACT', 'email': 'veronique.abadie@aphp.fr'}, {'name': 'Stéphanie PANNIER, MD, PhD', 'role': 'CONTACT', 'email': 'stephanie.pannier@aphp.fr'}], 'facility': 'Hôpital Necker - Enfants malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Anne-Laure SIMON, MD', 'role': 'CONTACT', 'email': 'anne-laure.simon@aphp.fr'}], 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Corinne BLANCHET, MD', 'role': 'CONTACT', 'email': 'corinne.blanchet@aphp.fr', 'phone': '01 58 41 24 26', 'phoneExt': '+33'}, {'name': 'Gael PLASTOW', 'role': 'CONTACT', 'email': 'gael.plastow@aphp.fr', 'phone': '01 44 38 18 57', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}