Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-08 @ 1:59 PM
Study NCT ID:
NCT05300295
Status:
COMPLETED
Last Update Posted:
2022-10-21
First Post:
2022-02-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mentorship Program for Individuals With Autism Spectrum Disorder (ASD)
Sponsor:
Organization:
Raw JSON
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AMP involves weekly meetings in an afterschool setting and targets the socio-emotional health and social connectedness of adolescents and adults with ASD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mentoring Program', 'description': 'Mentoring Program: UMN staff will engage participants, parents, and program staff in pre-, mid-, and post-program interviews, focus groups, and surveys. Furthermore, UMN staff will have access to program applications completed by participants and will receive weekly information from program staff regarding attendance and participant ratings of the weekly meetings'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-09', 'size': 494913, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-08T10:17', 'hasProtocol': True}, {'date': '2019-01-07', 'size': 353161, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-08T10:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2022-02-24', 'resultsFirstSubmitDate': '2022-07-08', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-20', 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Sessions Attended', 'timeFrame': 'within 30 days of the intervention end, up to 10 months', 'description': 'Median count of completed session visits'}, {'measure': 'Participant Program Satisfaction Scores', 'timeFrame': 'within 30 days of the intervention end, up to 10 months', 'description': 'Average program satisfaction score; range = 1-5; higher scores are better'}, {'measure': 'Mentoring Relationship Quality', 'timeFrame': 'within 30 days of the intervention end, up to 10 months', 'description': 'Average quality of the mentoring relationship score; range = 1-5; higher scores are better'}, {'measure': 'Child Behavior Checklist Scores (Internalizing Subscale)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': "Parent-completed assessment of child's internalizing behavior; T scores for the internalizing subscale range 0-100 with higher scores being worse"}, {'measure': 'Child Behavior Checklist Scores (Externalizing Subscale)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': "Parent-completed assessment of child's externalizing behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse"}, {'measure': 'Youth Self-Report Scores (Internalizing Subscale)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': 'Youth self-reported assessment of internalizing behavior; T scores for the internalizing subscale range 0-100 with higher scores being worse'}, {'measure': 'Youth Self-Report Scores (Externalizing Subscale)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': 'Youth self-reported assessment of externalizing behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse'}, {'measure': 'Social Skills Improvement System Scores (Social Competence Scale; Parent-report)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': "Parent-completed assessment of child's social competence; Standard scores for the social competence subscale range 40-160 with lower scores being worse"}, {'measure': 'Social Skills Improvement System Scores (Problem Behavior Scale; Parent-report)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': "Parent-completed assessment of child's problem behavior; Standard scores for the problem behavior subscale range 40-160 with higher scores being worse"}, {'measure': 'Social Skills Improvement System Scores (Social Competence Scale; Youth-report)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': 'Youth self-reported assessment of social competence; Standard scores for the social competence subscale range 40-160 with lower scores being worse'}, {'measure': 'Social Skills Improvement System Scores (Problem Behavior Scale; Youth-report)', 'timeFrame': 'at pre-intervention (within 30 days of intervention start) and post-intervention (within 30 days of intervention end), up to 10 months', 'description': 'Youth self-reported assessment of problem behavior; Standard scores for the problem behavior subscale range 40-160 with higher scores being worse'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism', 'Autism Spectrum Disorder'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot project is to evaluate the feasibility of a mentorship program for adolescents with autism spectrum disorder (ASD). Data will be collected from adolescents with ASD and their parents/guardians. Study findings will be used to inform further development of the mentoring program for individuals with ASD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder (ASD)\n* Age 14-18\n* Participants in the mentoring program.\n* Participants must have fluent language and will speak and understand English.\n* Participants must be able to commit to providing evaluation data.\n\nExclusion Criteria:\n\n* Have an intellectual disability (IQ under 70)'}, 'identificationModule': {'nctId': 'NCT05300295', 'briefTitle': 'Mentorship Program for Individuals With Autism Spectrum Disorder (ASD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Evaluation of a Mentorship Program for Individuals With Autism Spectrum Disorder (ASD)', 'orgStudyIdInfo': {'id': 'STUDY00003954'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mentoring Program', 'description': 'The Autism Mentorship Program is a psychosocial intervention that pairs adults and adolescents with autism spectrum disorder (ASD) in one-to-one mentoring relationships. AMP involves weekly meetings in an afterschool setting and targets the socio-emotional health and social connectedness of adolescents and adults with ASD.', 'interventionNames': ['Behavioral: Mentoring Program']}], 'interventions': [{'name': 'Mentoring Program', 'type': 'BEHAVIORAL', 'otherNames': ['Autism Mentorship Program'], 'description': 'The Autism Mentorship Program is a psychosocial intervention that pairs adults and adolescents with autism spectrum disorder (ASD) in one-to-one mentoring relationships. AMP involves weekly meetings in an afterschool setting and targets the socio-emotional health and social connectedness of adolescents and adults with ASD.', 'armGroupLabels': ['Mentoring Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Lindsey Weiler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}