Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-05 @ 11:53 AM
Study NCT ID:
NCT03820869
Status:
UNKNOWN
Last Update Posted:
2019-01-29
First Post:
2019-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect Of Occupational Therapy On Sensory-Based Feeding Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012736', 'term': 'Sex Education'}, {'id': 'D009788', 'term': 'Occupational Therapy'}], 'ancestors': [{'id': 'D044347', 'term': 'Sexology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-27', 'studyFirstSubmitDate': '2019-01-18', 'studyFirstSubmitQcDate': '2019-01-27', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dunn Sensory Profile', 'timeFrame': '8 weeks', 'description': 'It is a norm-referenced, parent-report questionnaire. The parent rates frequency of each item on a 5-point Likert scale from 1= always to 5= never. It reports the frequency of behavioural occurrences that are used to measure the patterns of performance indicative of difficulties experienced in sensory processing'}], 'secondaryOutcomes': [{'measure': 'BAMBİ', 'timeFrame': '8 weeks', 'description': 'The BAMBI is rated based on a parent proxy report, with a 5-point grading type scale (1 = Never/Very Rarely -5 = At Almost All Mealtimes). It was designed to capture mealtime behaviors specific to children with ASD.'}, {'measure': 'STEP', 'timeFrame': '8 weeks', 'description': 'It is used for to identify the feeding problems of persons with ID in terms of (a) risk of aspiration, (b) food selectivity, (c) feeding skills deficits, (d) food refusal and associated behavior problems, and (e) nutrition-related behavior problems'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feeding Disorder', 'Autism Spectrum Disorder', 'Sensory Integration Disorder (Disorder)']}, 'descriptionModule': {'briefSummary': 'Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.', 'detailedDescription': 'Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASD\n* Feeding problems'}, 'identificationModule': {'nctId': 'NCT03820869', 'briefTitle': 'The Effect Of Occupational Therapy On Sensory-Based Feeding Problems', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effect Of Occupational Therapy On Sensory-Based Feeding Problems Of Children Wth Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '2018/454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Children with ASD', 'interventionNames': ['Other: Family Training']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Children with ASD', 'interventionNames': ['Other: Occupational Therapy']}], 'interventions': [{'name': 'Family Training', 'type': 'OTHER', 'description': 'Family Training', 'armGroupLabels': ['Control']}, {'name': 'Occupational Therapy', 'type': 'OTHER', 'description': 'Occupational Therapy', 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Özgü İNAL', 'investigatorAffiliation': 'Hacettepe University'}}}}