Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT07203105
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GAINS Expert Guiding Technology to Coach Life Skill Teaching
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child independent life skill performance', 'timeFrame': '60 days', 'description': 'The life skill steps (as determined by pre-treatment task analysis) the child performs without caregiver prompts divided by total life skill steps.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism Spectrum Disorder', 'Technology', 'Behavior Intervention'], 'conditions': ['GAINS Expert Guiding Technology to Coach Life Skill Teaching']}, 'descriptionModule': {'briefSummary': 'Based on proven techniques in operant conditioning, the expert behavior guiding functionality in GAINS to teach life skills will be evaluated. Behavior practitioners will develop task analyses that break down complex life skills into simpler component steps and then enter these tasks into the GAINS system. In a similar way to navigation systems for drivers, GAINS will provide behavioral navigation for caregivers implementing ABA therapy programs. Using the GAINS app on a tablet or smartphone, caregivers will receive automatically updated visual and audio behavioral guidance, that includes what to do, when to do it, and detailed step-by-step guidance on how to execute ABA therapy programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only children ages 3 through 10 years who present with Autism Spectrum Disorder (ASD) will be recruited for this study.\n\nExclusion Criteria:\n\n* No individuals will be excluded or included based on race, ethnicity, or gender'}, 'identificationModule': {'nctId': 'NCT07203105', 'briefTitle': 'GAINS Expert Guiding Technology to Coach Life Skill Teaching', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guiding Technologies Corporation'}, 'officialTitle': 'GAINS Expert Guiding Technology to Coach Life Skill Teaching', 'orgStudyIdInfo': {'id': '1R43MH130298-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43MH130298-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R43MH130298-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43MH130298-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GAINS expert guiding technology to coach life skill teaching', 'interventionNames': ['Behavioral: GAINS expert guiding technology to coach life skill teaching']}], 'interventions': [{'name': 'GAINS expert guiding technology to coach life skill teaching', 'type': 'BEHAVIORAL', 'description': 'GAINS expert guiding technology to coach life skill teaching', 'armGroupLabels': ['GAINS expert guiding technology to coach life skill teaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72701', 'city': 'Fayetteville', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth R Lorah, Ph.D.', 'role': 'CONTACT', 'email': 'lorah@uark.edu', 'phone': '(479) 575-7244'}], 'facility': 'University of Arkansas', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'SBIR Grant recipients are not required to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guiding Technologies Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}