Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT05910658
Status:
UNKNOWN
Last Update Posted:
2024-08-21
First Post:
2023-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-27', 'releaseDate': '2025-03-10'}], 'estimatedResultsFirstSubmitDate': '2025-03-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016743', 'term': 'Mental Competency'}], 'ancestors': [{'id': 'D007603', 'term': 'Jurisprudence'}, {'id': 'D012926', 'term': 'Social Control, Formal'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-10-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sexual Vocabulary Test', 'timeFrame': 'At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)', 'description': 'A measure of the ability to provide definitions of sexual health terms to be used as a measure of target engagement (higher score indicates higher level of knowledge)'}, {'measure': 'Mathtech Behavioral Scale', 'timeFrame': 'At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)', 'description': 'A measure of sexual health and intimate behavior to be used as a primary outcome in a future trial (higher scores indicate higher levels of behavior)'}], 'primaryOutcomes': [{'measure': 'Acceptability Rating Scale', 'timeFrame': 'At baseline enrollment visit and weekly throughout training for a total of 20 weeks', 'description': 'A measure of the acceptability of methods used in the project including qualitative interview and 5-point rating scale (lower scores indicate higher acceptability)'}], 'secondaryOutcomes': [{'measure': 'Feasibility Assessment', 'timeFrame': 'At baseline enrollment visit and weekly throughout training for a total of 20 weeks', 'description': 'Analysis of missing items or session content that cannot be completed (fewer missing items indicates better feasibility)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism', 'Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the feasibility and acceptability of a behavioral intervention in designed to provide sexual education and improve the behavioral skills of autistic adults for intimate relationships.\n\nThe main questions it aims to answer are:\n\n* Acquire feasibility and acceptability data for delivery of the CRUSH curriculum in a group didactic setting plus 1-1 coaching.\n* Acquire feasibility and acceptability data regarding the assessment battery for future clinical trials.\n\nParticipants will complete:\n\n* A screening call.\n* Provide documentation of a diagnosis of autism spectrum disorder.\n* 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing).\n* 15-20 training sessions to participate in the CRUSH curriculum. After each session, provide feedback about the session.', 'detailedDescription': 'The goal of this clinical trial is to learn about the feasibility and acceptability of a behavioral intervention in designed to provide sexual education and improve the behavioral skills of autistic adults for intimate relationships, called CRUSH.\n\nThe main questions it aims to answer are:\n\n* Acquire feasibility and acceptability data for delivery of the CRUSH curriculum in a group didactic setting plus 1-1 coaching.\n* Acquire feasibility and acceptability data regarding the assessment battery for future clinical trials.\n\nParticipants will complete:\n\n* A screening call.\n* Provide documentation of a diagnosis of autism spectrum disorder.\n* 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing).\n* 15-20 training sessions to participate in the CRUSH curriculum. After each session, provide feedback about the session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 30 years old;\n* Documentation of a prior diagnosis of autism spectrum disorder (ASD) or receipt of services based on an ASD diagnosis;\n* Ability to provide consent for the protocol and understand task demands (i.e., approximately WASI-2 full scale IQ of 70 or above);\n* Fluent in English\n\nExclusion Criteria:\n\n* Non-English-speaking participants (less than 50% of speech in English);\n* Known genetic etiology of ASD (e.g., Fragile X);\n* Major mental illness (e.g., bipolar disorder, schizophrenia, or psychosis).\n* Live more than 35 miles from Two Brookline Place, Brookline, MA where intervention sessions will be offered.'}, 'identificationModule': {'nctId': 'NCT05910658', 'briefTitle': 'First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum', 'orgStudyIdInfo': {'id': 'FP01030935'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Group', 'description': 'Participants will receive the CRUSH Curriculum', 'interventionNames': ['Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)']}], 'interventions': [{'name': 'Competence in Romance and Understanding Sexual Health (CRUSH)', 'type': 'BEHAVIORAL', 'description': 'Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital, Two Brookline Place", 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Susan Faja', 'investigatorAffiliation': "Boston Children's Hospital"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-10', 'type': 'RELEASE'}, {'date': '2025-03-27', 'type': 'RESET'}], 'unpostedResponsibleParty': "Susan Faja, Associate Professor, Boston Children's Hospital"}}}}