Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-03 @ 7:21 PM
Study NCT ID:
NCT06859918
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D020817', 'term': 'Asperger Syndrome'}, {'id': 'D066107', 'term': 'Social Skills'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068356', 'term': 'Self-Control'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004347', 'term': 'Drug Interactions'}], 'ancestors': [{'id': 'D000069437', 'term': 'Pharmacological Phenomena'}, {'id': 'D002620', 'term': 'Pharmacological and Toxicological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study involves two groups of participants, who both receive the intervention at different times. The "Immediate Start Group" will get the intervention at the beginning of the trial, while the "Delay Start Group" will receive the intervention 1-6 months after the Immediate Start Group. Participants will be randomly assigned to groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Responsiveness Scale (SRS) - Self Report', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.'}], 'secondaryOutcomes': [{'measure': 'Social Responsiveness Scale (SRS) - Informant Report', 'timeFrame': 'From enrollment to 6 months follow up', 'description': "A 65 item measure that identifies the presence and severity of social impairment within the autism spectrum. This is completed by a friend/family member of the participant based on their perceptions of the participants' behavior."}, {'measure': 'CAT-Q - Camouflaging Autistic Traits Questionnaire', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 25 item measure that assesses the extent to which individuals with autism mask or camouflage their autistic traits in social situations.'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 39-item measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.'}, {'measure': 'Generalized Anxiety Disorder-7', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 7-item measure that assesses the severity of generalized anxiety disorder symptoms.'}, {'measure': 'Glasgow Sensory Questionnaire', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 42-item measure that assesses sensory sensitivities and differences across multiple sensory modalities.'}, {'measure': 'Insomnia Severity Inde', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 7-item measure that assesses the severity of insomnia symptoms and their impact on daily functioning.'}, {'measure': 'Inventory of Socially Supportive Behaviors', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 40-item measure that assesses the frequency and types of social support individuals receive.'}, {'measure': 'Social Network Index', 'timeFrame': 'From enrollment to 6 months follow up', 'description': "A 12-item measure that assesses the size, diversity, and level of engagement in an individual's social network."}, {'measure': 'Scales of Psychological Wellbeing', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 42 item measure that assesses six dimensions of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.'}, {'measure': 'Attunement Quiz', 'timeFrame': 'From enrollment to 6 months follow up', 'description': "A 25 item measure that assess attunement: one's ability to perceive, interpret, and respond to one's internal and external environment, in particular the social environment."}, {'measure': 'Liebowitz Social Anxiety Scale - Self-Report', 'timeFrame': 'From enrollment to 6 months follow up', 'description': 'A 24-item measure that assesses the severity of social anxiety symptoms related to fear and avoidance in social and performance situations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Social Skills', 'Emotion Regulation', 'Autistic Adults'], 'conditions': ['Autism Spectrum Disorder', 'Autism', 'Autistic Disorder', 'Asperger Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.\n\nThe treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.\n\nThe Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Meet ASD diagnostic criteria supported by an outside diagnostic evaluation and/or by the clinical and developmental information gathered from a phone screen\n* Be willing to complete screening surveys (outcome measures)\n* Social Responsiveness Score, Second Edition, self-report SRS survey score of greater than or equal to 60\n\nExclusion Criteria:\n\n* Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months\n* Major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months\n* A history of intellectual disability or low Shipley-2 score'}, 'identificationModule': {'nctId': 'NCT06859918', 'briefTitle': 'Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'ASPE Subproject - Training to Understand and Navigate Emotions and Interactions (TUNE In)', 'orgStudyIdInfo': {'id': 'TUNE In 3.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Delay Start Group', 'description': 'The Delay Start Group receives the intervention 1-6 months after the Immediate Start Group.', 'interventionNames': ['Behavioral: TUNE In: Training to Understand and Navigate Emotions and Interactions']}, {'type': 'EXPERIMENTAL', 'label': 'Immediate Start Group', 'description': 'The Immediate Start Group receives the intervention as soon as the trial starts.', 'interventionNames': ['Behavioral: TUNE In: Training to Understand and Navigate Emotions and Interactions']}], 'interventions': [{'name': 'TUNE In: Training to Understand and Navigate Emotions and Interactions', 'type': 'BEHAVIORAL', 'description': 'A cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. TUNE In includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, and social skills.', 'armGroupLabels': ['Delay Start Group', 'Immediate Start Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Giulietta Flaherty', 'role': 'CONTACT', 'email': 'flahertyg@pennmedicine.upenn.edu'}], 'facility': 'Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Edward Brodkin, M.D', 'role': 'CONTACT', 'email': 'ebrodkin@pennmedicine.upenn.edu', 'phone': '215-746-4100'}, {'name': 'Giulietta Flaherty, PsyD', 'role': 'CONTACT', 'email': 'flahertyg@pennmedicine.upenn.edu', 'phone': '7322595506'}], 'overallOfficials': [{'name': 'Edward Brodkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Deidentified data will be uploaded to NDAR upon completion of the trial', 'ipdSharing': 'YES', 'description': 'Data will be available through NIH NDAR registry'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}