Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 6:51 PM
Study NCT ID:
NCT06740760
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2024-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autism Genomics Sweden - Genetic Guidance and Information Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005817', 'term': 'Genetic Counseling'}], 'ancestors': [{'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2024-12-14', 'studyFirstSubmitQcDate': '2024-12-14', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Genetic Counselling Scale - 24 (mGCOS-24)', 'timeFrame': 'At enrollment (pre), 1-2 weeks after intervention (post)', 'description': 'Measures changes in empowerment, understanding, and ability to use genetic information.\n\nAdditional information: The mGCOS has been translated into Swedish based on the GCOS-validated Swedish translation.\n\nChange in the primary outcome will be compared between the two groups of active interventions. Subgroup analyses will be performed based on those receiving their personal genetic information vs those receiving only general population-level information.'}], 'secondaryOutcomes': [{'measure': 'Generalised Anxiety Disorder Questionnaire (GAD-7)', 'timeFrame': 'Pre - Post (1-2 weeks)', 'description': 'We will monitor the change in GAD-7 from pre to post.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Pre - Post (1-2 weeks)', 'description': "Evaluates changes in participants' depression symptoms"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genetic information', 'polygenic scores', 'rare variants', 'genetic counselling', 'genetic knowledge'], 'conditions': ['Autism', 'Autism Spectrum Disorder', 'ADHD - Attention Deficit Disorder With Hyperactivity', 'Depression Anxiety Disorder', 'Depression - Major Depressive Disorder', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'This observational clinical trial aims to evaluate whether providing genetic information about the origins of autism and related psychiatric disorders enhances understanding, well-being, and empowerment in adolescents and young adults with autism. The study will compare the outcomes of two groups: one receiving a 1.5-hour genetic counseling session with a clinician and the other receiving general genetic information via a leaflet. Participants will be assessed using pre- and post-intervention questionnaires, including measures of understanding of their condition (mGCOS-24) and mental health (GAD-7 and PHQ-9). The study also explores whether mental health factors like anxiety and depression influence the effectiveness of the interventions.', 'detailedDescription': "The goal of this observational clinical study is to assess whether receiving genetic information about the origins of autism and related neuropsychiatric disorders, either at a population level or as individual information after genetic testing, can improve understanding of their condition, well-being, and empowerment in adolescents and young adults with autism spectrum condition (ASC). The main questions to answer are:\n\n* Does a genetic counseling session improve participants' understanding of autism and its origins, well-being, and empowerment as measured by the modified Genetic Counseling Outcome Scale (mGCOS-24)?\n* Is the outcome modified by mental health indicators such as anxiety and depression measures, and does the information improve these?\n* We will also assess how genetic knowledge and beliefs before the genetic information session affect the main outcome of the mGCOS-24 change.\n\nThe comparison will be made between the group receiving a 1.5-hour genetic counseling session with a clinician and a group receiving general genetic information via leaflet by email to see if the genetic information session by the clinician leads to greater improvements in understanding, empowerment, and well-being.\n\nParticipants will:\n\n* Answer basic demographic questionnaire as well as a questionnaire about genetic knowledge and beliefs\n* Be randomized to receive a 1-1.5 hour genetic counseling session in person or online, or general genetic information via leaflet.\n* Complete pre- and post-intervention questionnaires, including the mGCOS-24, GAD-7, and PHQ-9."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 15 - 30 years of age.\n* Living in Sweden.\n* Able to consent independently or with guardian consent if necessary.\n* Understanding of Swedish-language questions.\n* Interest in receiving genetic counselling information on autism.\n\nExclusion Criteria:\n\n* Participants unwilling to complete pre- or post-intervention surveys.\n* Participants unwilling to participate in either form of genetic counseling'}, 'identificationModule': {'nctId': 'NCT06740760', 'acronym': 'AuGeS-GV', 'briefTitle': 'Autism Genomics Sweden - Genetic Guidance and Information Trial', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Autism Genomics Sweden - AuGeS - Genetic Information and Guidance in Autism and Related Psychiatric Conditions Trial', 'orgStudyIdInfo': {'id': '2023-06737-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clinician led genetic information session', 'description': 'Clinician-led structured genetic information session in person or through an online video link. Participants with genetic information available (clinically significant rare variants from exome sequencing and copy number variant analysis, and polygenic scores (autism, ADHD, depression, and anxiety), these will also be communicated as the last part of the session.', 'interventionNames': ['Behavioral: Genetic counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leaflet genetic information', 'description': 'The participants receive a leaflet with genetic information without in-person contact', 'interventionNames': ['Behavioral: Leaflet']}], 'interventions': [{'name': 'Genetic counselling', 'type': 'BEHAVIORAL', 'description': 'Behavioral: genetic counselling', 'armGroupLabels': ['Clinician led genetic information session']}, {'name': 'Leaflet', 'type': 'BEHAVIORAL', 'description': 'Genetic information as a form of a leaflet', 'armGroupLabels': ['Leaflet genetic information']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Kristiina Tammimies, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'March 2025 -', 'ipdSharing': 'YES', 'description': 'The data dictionary will be shared openly; however, the individual-level data will be restricted to necessary clearance from the Karolinska Institutet and the Swedish Ethical Review Authority through the KI Data Repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Docent (Associate Professor), Senior Researcher', 'investigatorFullName': 'Kristiina Tammimies', 'investigatorAffiliation': 'Karolinska Institutet'}}}}