Mental Health IssueNCT06488404
Implementation Science to Improve School Ethos for Mental Health
An observational study of Mental Health Issue, run by University of Pittsburgh at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- How many people
- 47 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- Students between 12-18 years of age
- Teachers 25-60 years of age
- Parents 25-60 years of age
- Management 25-60 years of age
- Mental health professionals 25-60 years of age
- School counsellors 25-60 years of age
- Education department - Government of Tamil Nadu 25-60 years of age
- Health department - Government of Tamil Nadu 25-60 years of age
Who cannot join
- Not willing to provide informed consent
- Can not speak either English or Tamil (native language)
Trial locations and contacts
1 site in 1 country.
India1 site
Schizophrenia Research Foundation (SCARF India)
Chennai, Tamil Nadu, 600101.
About this study
Official title: Improving School Ethos Towards Mental Health Through Whole School Mental Health Interventions: Implementation Science Approach
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.
Read the detailed description
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.
After 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
- Conditions
- Mental Health Issue
- Keywords
- Mental Health, School ethos, In depth interview
- Medical subject headings
- Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
School ethos
Understanding the school ethos towards mental health prevailing in the schools from urban settings using in-depth interviews
Measured: for six months
Challenges and bariers
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
Measured: For six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jun 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Schizophrenia Research Foundation (SCARF India), Chennai, India
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, MD, PhD, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488404
- Sponsor's protocol ID
- STUDY22120105
- Other IDs
- D43TW009114
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving School Ethos Towards Mental Health Through Whole School Mental Health Interventions: Implementation Science Approach
- ClinicalTrials.gov ID
- NCT06488404
- Acronym / sponsor ID
- STUDY22120105
- Conditions
- Mental Health Issue
- Keywords
- Mental Health, School ethos, In depth interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Schizophrenia Research Foundation (SCARF India), Chennai, India
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
After 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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Students between 12-18 years of age
- Teachers 25-60 years of age
- Parents 25-60 years of age
- Management 25-60 years of age
- Mental health professionals 25-60 years of age
Key exclusion criteria (2 listed)
- Not willing to provide informed consent
- Can not speak either English or Tamil (native language)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
School ethos
Time frame: for six months
Understanding the school ethos towards mental health prevailing in the schools from urban settings using in-depth interviews
Challenges and bariers
Time frame: For six months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishwajit L Nimgaonkar, MD, PhD principal investigator
University of Pittburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue, run by University of Pittsburgh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School ethos (time frame: for six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.