Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05341505
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Emotion Regulation Therapy in Young Autistic Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2022-04-17', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adult Self Report (ASR)', 'timeFrame': 'Baseline', 'description': 'Externalizing and internalizing composite scores'}, {'measure': 'Adult Self Report (ASR)', 'timeFrame': '8 weeks', 'description': 'Externalizing and internalizing composite scores'}, {'measure': 'Adult Self Report (ASR)', 'timeFrame': '2 months follow-up', 'description': 'Externalizing and internalizing composite scores'}, {'measure': 'Adult Behavior Checklist (ABC-L)', 'timeFrame': 'Baseline', 'description': 'Externalizing and internalizing composite scores'}, {'measure': 'Adult Behavior Checklist (ABC-L)', 'timeFrame': '8 weeks', 'description': 'Externalizing and internalizing composite scores'}, {'measure': 'Adult Behavior Checklist (ABC-L)', 'timeFrame': '2 months follow-up', 'description': 'Externalizing and internalizing composite scores'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emotion regulation'], 'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': 'This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.', 'detailedDescription': 'Five young adults with ASD with emotional/behavioral challenges that are attributed to emotion dysregulation will be enrolled into an emotion regulation (ER) intervention administered twice weekly for a total of 16 sessions. Participants will be evaluated pre- and post-treatment using behavioral and imaging measures, and at mid-treatment and 2-month follow-up using behavioral measures administered electronically and/or via phone interview.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder\n* Ages 18-40\n* Estimated full-scale IQ ≥ 80\n* T score \\> 60 on either the externalizing or internalizing symptoms scores of either the Adult Behavior Checklist (ABC-L) or the Adult Self Report (ASR)\n* Participation in previous study at the Olin Center ("Social Emotional Study"; E-HHC- 2018-0241)\n\nExclusion Criteria:\n\n* Intellectual disability (estimated full scale IQ\\<80\n* History of a significant head injury (severe concussion, hospitalization)\n* History of neurosurgery\n* History of epilepsy, stroke, MS, a neurodegenerative disorder, or any other neurological disorder\n* A current major medical condition (e.g. cancer, heart failure)\n* Current substance use (determined by urine screen done to all participants before each MRI scan)\n* In-body metal implants (e.g. surgical clips, certain pacemakers) or history of exposure to metal shards or other MRI contraindications\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05341505', 'briefTitle': 'Outcomes of Emotion Regulation Therapy in Young Autistic Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': 'R-HHC-2017-0161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ER intervention', 'description': 'Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks.', 'interventionNames': ['Behavioral: Emotion Regulation Intervention']}], 'interventions': [{'name': 'Emotion Regulation Intervention', 'type': 'BEHAVIORAL', 'description': 'We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.', 'armGroupLabels': ['ER intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michal Assaf, MD', 'role': 'CONTACT', 'email': 'michal.assaf@hhchealth.org', 'phone': '860-545-7792'}, {'name': 'Michal Assaf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gretchen Diefenbach, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Living, Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michal Assaf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Autism & Functional Mappin lab', 'investigatorFullName': 'Michal Assaf', 'investigatorAffiliation': 'Hartford Hospital'}}}}