Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-07 @ 9:26 PM
Study NCT ID:
NCT06488404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation Science to Improve School Ethos for Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'School ethos', 'timeFrame': 'for six months', 'description': 'Understanding the school ethos towards mental health prevailing in the schools from urban settings using in-depth interviews'}, {'measure': 'Challenges and bariers', 'timeFrame': 'For six months', 'description': 'Making a list of the challenges and opportunities in establishing and implementing a positive school ethos towards mental health in the schools using in-depth interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mental Health', 'School ethos', 'In depth interview'], 'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to identify the challenges and opportunities existing within the school ethos in implementing evidence-based interventions to improve youth mental health and to identify the most appropriate implementation strategies for improving mental health among young people in schools at Chennai, a city in Southern part of India, a low- and middle- income country setting.', 'detailedDescription': "The study team will approach the schools where the proposed study will take place and will obtain the needed permission to conduct the study in the school premises. Information about the study to all the potential participants will be disseminated through the school management. All the potential participants can approach the study team to learn more about the study and participate in the study. Potential participants approaching the study team will be explained in detail about the project and informed consent and /or assent will be obtained. The participants will be selected based on the proposed inclusion and exclusion criteria of the study.\n\nAfter the recruitment of the participants, iIn-depth, semi-structured, individual interviews lasting approximately an hour will be conducted in either English or Tamil. This will be conducted by trained qualitative researchers. Interviews will be audiotaped and transcribed verbatim. A qualitative descriptive approach will guide all aspects of the qualitative methods we employ to derive a comprehensive description of participants' experiences that is both deep and meaningful. The IDI guide will be developed following an extensive literature search and discussions with experts in the field, for understanding the participants. The interviews will be conducted by two members of the research team. Face-to-face interviews or online interviews will be conducted after ensuring that the participant is comfortable, and all external disturbances will be taken care or minimized"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the interviews and the quantitative assessment will be conducted with the students, staff, parents, and management of the selected schools. Besides these, few interviews will be conducted with Government officials who are working with youth mental health and education, experts on school mental health and other relevant individuals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students between 12-18 years of age\n* Teachers 25-60 years of age\n* Parents 25-60 years of age\n* Management 25-60 years of age\n* Mental health professionals 25-60 years of age\n* School counsellors 25-60 years of age\n* Education department - Government of Tamil Nadu 25-60 years of age\n* Health department - Government of Tamil Nadu 25-60 years of age\n\nExclusion Criteria:\n\n* Not willing to provide informed consent\n* Can not speak either English or Tamil (native language)'}, 'identificationModule': {'nctId': 'NCT06488404', 'briefTitle': 'Implementation Science to Improve School Ethos for Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Improving School Ethos Towards Mental Health Through Whole School Mental Health Interventions: Implementation Science Approach', 'orgStudyIdInfo': {'id': 'STUDY22120105'}, 'secondaryIdInfos': [{'id': 'D43TW009114', 'link': 'https://reporter.nih.gov/quickSearch/D43TW009114', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '600101.', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Schizophrenia Research Foundation (SCARF India)', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}], 'overallOfficials': [{'name': 'Vishwajit L Nimgaonkar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'One year after publication of this study.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'For individual participant data, meta-analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}, {'name': 'Schizophrenia Research Foundation (SCARF India), Chennai, India', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vishwajit Nimgaonkar, MD PhD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}