Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-02 @ 2:46 PM
Study NCT ID:
NCT03510156
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2018-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Disruptive Behaviors in Fragile X Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005600', 'term': 'Fragile X Syndrome'}, {'id': 'D000066553', 'term': 'Problem Behavior'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks', 'timeFrame': '0, 4, 8, 12, 16 weeks', 'description': 'Aberrant Behavior Checklist - Community (ABC-C)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline level of treatment acceptability at 4, 8, 12 and 16 weeks', 'timeFrame': '0, 4, 8, 12, 16 weeks', 'description': 'Treatment Acceptability Rating Form - Revised (TARF-R)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fragile X Syndrome', 'Disruptive Behavior']}, 'referencesModule': {'references': [{'pmid': '36180840', 'type': 'DERIVED', 'citation': 'Hall SS, Rodriguez AB, Jo B, Pollard JS. Long-term follow-up of telehealth-enabled behavioral treatment for challenging behaviors in boys with fragile X syndrome. J Neurodev Disord. 2022 Sep 30;14(1):53. doi: 10.1186/s11689-022-09463-9.'}, {'pmid': '33218305', 'type': 'DERIVED', 'citation': 'Hall SS, Monlux KD, Rodriguez AB, Jo B, Pollard JS. Telehealth-enabled behavioral treatment for problem behaviors in boys with fragile X syndrome: a randomized controlled trial. J Neurodev Disord. 2020 Nov 20;12(1):31. doi: 10.1186/s11689-020-09331-4.'}]}, 'descriptionModule': {'briefSummary': "Disruptive behaviors such as self-injury, aggression, and property destruction pose significant health-related issues to children diagnosed with fragile X syndrome (FXS), impacting the child's quality of life and causing significant distress to families.\n\nAccess to appropriate treatment for families is severely limited by factors such as cost of care, shortages of qualified treatment providers, and geographic spread of children with FXS across the country. To address these potential issues, the effectiveness of administering a standardized function-based behavioral treatment for problem behaviors in FXS will be evaluated using telemedicine. The proposed study intervention therefore offers a tremendous step forward in clinical research both in the field of FXS and in the field of developmental disabilities more broadly, and thus will have a significant impact on public health."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Child has a confirmed diagnosis of FXS (\\>200 CGG repeats on the FMR1 gene with evidence of aberrant methylation)\n2. Child is male, between the ages of 3-10 years old\n3. Child is reported to show self-injury, property destruction and/or aggression on at least a daily basis\n4. The caregiver agrees to keep any therapies that the child receives (i.e., medications or other treatments) as stable as possible throughout involvement in the study\n5. The family has a high-speed internet connection at home or lives in an area with 4G network coverage\n6. Availability for one-hour daily telemedicine treatment sessions\n7. Availability for in-home assessment totaling 8 hours across two consecutive days\n\nExclusion Criteria:\n\n1. The child or caregiver has significant sensory impairments (e.g., blindness or deafness)\n2. Non-English speaking\n3. The child receives Applied Behavior Analysis services in excess of five hours per week\n4. The child has a significant neurological condition (e.g., frequent seizures, brain injury, Tourette's syndrome) that would preclude participation\n5. The child or caregiver has significant mobility issues\n6. The child is currently participating in another research study that would preclude participation in the study"}, 'identificationModule': {'nctId': 'NCT03510156', 'briefTitle': 'Treatment of Disruptive Behaviors in Fragile X Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Treatment of Disruptive Behaviors in Fragile X Syndrome', 'orgStudyIdInfo': {'id': '36394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Behavioral: Behavior analytic treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Observation'}], 'interventions': [{'name': 'Behavior analytic treatment', 'type': 'BEHAVIORAL', 'description': 'Function-based treatment', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Department of Psychiatry and Behavioral Sciences', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Scott S Hall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The John Merck Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Scott Hall', 'investigatorAffiliation': 'Stanford University'}}}}