Suicidal IdeationNCT06474312
Reducing Suicide Ideation Among Young People
A study testing Nae Disha in people with Suicidal Ideation and Suicide, Attempted, run by University of Pittsburgh at 1 site in India.
Trial summary
It is Cluster Randomized Control Trial research to examine feasibility and relevance of the modified tool Nae Disha for Life, which will incorporate suicide prevention and resilience to reduce suicide ideation among young people in Bundelkhand region of Madhya Pradesh, India. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Nae Disha
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students of 7th and 8th classes of selected schools between 12 - 17 years old age group,
Who cannot join
- a. Students who are planning to move to other schools during intervention period
- Students of 7th/8th grade who turn 18 during the study.
- Those with chronic debilitating diseases or disorders who cannot participate in Nae Disha activities such as heart disease, epilepsy, cystic fibrosis, cerebral palsy, and any other diseases that the doctor has restricted the student to participate in it.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Examine the Feasibility, Relevance, and Effectiveness of the Tool "Nae Disha for Life" Module in Reducing Suicide Ideation Among Young People in Bundelkhand Region of Madhya Pradesh, India
It is Cluster Randomized Control Trial research to examine feasibility and relevance of the modified tool Nae Disha for Life, which will incorporate suicide prevention and resilience to reduce suicide ideation among young people in Bundelkhand region of Madhya Pradesh, India. This intervention will build on existing relationships with at least four Government Middle Schools in Nowgong block of Chhatarpur district, Madhya Pradesh. This preliminary research will develop relationships and evidence for implementation scale-up research.
Read the detailed description
Madhya Pradesh state in India was ranked as third highest number of suicides reported in 2020 in India. The majority of suicide victims (23.4%) (35,771) were educated up to Matriculation/ Secondary level. A large proportion of suicide deaths occur between the ages 15 and 29. Mental health problems begin during youth (12-24) years of age, however, is often detected later in life.
"Nae Disha for Life" is a brief, multi-component, psychosocial promotion and resilience tool developed by Emmanuel Hospital Association, New Delhi. The purpose of this research work is to evaluate the feasibility, acceptance, and effectiveness of "Nae Disha for Life" tool in reducing suicide ideation among youth in Bundelkhand region. This will be implemented among the targeted schools of Nowgong block, Chhatarpur district.
There are number of studies on treatment gaps for the mental health problems, suicide statistical analysis, methods of suicides, and causes of suicides. But there is hardly any study on prevention of suicides or suicidal ideation among the youth in India.
However, Nae Disha is a youth resilience group-based intervention building on the Ottawa health promotion charter, that aims to increase and strengthen key psycho-social assets in adolescents to moderate the impacts of adversity. It has been successfully implemented amongst out-of-school adolescents in Northern India and studies have demonstrated effectiveness in improving perceptions of social inclusion, attitudes to gender equality, resilience, and mental health among young people affected by mental illness. The Nae Disha would also deliver benefits to other young people similarly affected in other parts of India, and possibly beyond.
Building on these studies, I propose to examine feasibility and relevance of the modified tool Nae Disha for Life, which will incorporate suicide prevention and resilience to reduce suicide ideation among young people in Bundelkhand region of Madhya Pradesh. This intervention will build on existing relationships with at least four Government Middle Schools in Nowgong block of Chhatarpur district, Madhya Pradesh. This preliminary research will develop relationships and evidence for implementational scale-up research.
The research activities of the study is distributed as follows:
4 months(16weeks), Training of surveyors, Training staff as Facilitators, Meeting with local, stakeholders / communities, Refinement of program content.
Next two weeks:Recruiting of subjects from 4 schools, Screening of subjects in 4 schools, Formation of groups in 4 schools,Baseline data collection from subjects,
18 weeks (Week 17-to week 34):Intensive implementation in intervention arm and control arm in 4 schools 2 (Week 35-36) weeks:Endline quantitative and qualitative data collection 6 weeks(week 37-week:43) Data entry, analysis and presentation of data findings After week 43: Dissemination meetings to be held at in schools and Chhatarpur
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Being tested
- Nae Disha
- Keywords
- Nai Dish, Suicide ideation, Cue based, suicide attempts
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nae DishaBehavioural
"Nae Disha for Life" is a brief, multi-component, psychosocial promotion and resilience tool developed by Emmanuel Hospital Association, New Delhi. The purpose of this research work is to evaluate the feasibility, acceptance, and effectiveness of "Nae Disha for Life" tool in reducing suicide ideation among youth in Bundelkhand region. This will be implemented among the targeted schools of Nowgong block, Chhatarpur district.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Nae Disha | Experimental | "Nae Disha for Life" is a brief, multi-component, psychosocial promotion and resilience tool developed by Emmanuel Hospital Association, New Delhi. The purpose of this research work is to evaluate the feasibility, acceptance, and effectiveness of "Nae Disha for Life" tool in reducing suicide ideation among youth in Bundelkhand region. This will be implemented among the targeted schools of Nowgong block, Chhatarpur district. Receives: Behavioral: Nae Disha |
| Control arm | No intervention | The control arm will not get any intervention, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reporting Questionnaire-20 (SRQ-20) Score
Mental health was assessed using the Self-Reporting Questionnaire-20 (SRQ-20). The SRQ-20 measures general psychiatric symptomatology. Total scores range from 0 to 20, with higher scores indicating worse mental health or more severe symptoms
Measured: Baseline and after 18 weeks of intervention (Nae Disha modules)
Beck Depression Inventory-II (BDI-II) Score
Beck Depression Inventory-II (BDI-II): The BDI-II is a widely used self-report scale designed to assess the severity of depressive symptoms. It consists of 21 items, each scored on a scale from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate greater severity of depression and therefore represent a worse outcome.
Measured: Baseline and after 18 weeks of intervention
Beck Scale for Suicidal Ideation (BSS) Score
Beck Scale for Suicidal Ideation (BSS): The BSS is a self-report scale used to assess the severity of suicidal ideation. It consists of 21 items, each scored on a scale from 0 to 2, with a total score typically ranging from 0 to 38 based on the first 19 items. Higher scores indicate greater severity of suicidal thoughts and therefore represent a worse outcome.
Measured: Baseline and after 18 weeks of intervention (Nae Disha modules)
Brief Resilience Scale Score
Connor-Davidson Resilience Scale-10 (CD-RISC-10): The CD-RISC-10 is a self-report scale used to assess psychological resilience. It consists of 10 items, each scored on a scale from 0 to 4, with a total score ranging from 0 to 40. Higher scores indicate greater resilience and therefore represent a better outcome.
Measured: Baseline and after 18 weeks of intervention (Nae Disha modules)
Generalized Anxiety Disorder-7 (GAD-7) Score
Generalized Anxiety Disorder-7 (GAD-7): The GAD-7 is a self-report scale used to assess the severity of generalized anxiety disorder. It consists of 7 items, each scored on a scale from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate greater severity of anxiety and therefore represent a worse outcome.
Measured: Baseline and after 18 weeks of intervention (Nae Disha Modules)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Aug 2023
- Primary completion26 Feb 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a Cluster Randomized Control Trial (CRCT) research / study. The selection and approval of 64 Government schools was obtained will be done by the local PI based on comparable demographics (i.e. similar levels of socio-economic status) in the Nowgong block of Chhatarpur district. Two of the four schools will receive the intervention (intervention arm) and the other two will be the control arm. A sample size of n = 170 young people in each arm will be recruited from participating schools who are studying in 7th and 8th classes, aged between 12 - 17 years old. Sample size was calculated using optimal design software. The demographic data (e.g. age, father and mother completed years of education, caste, religion, etc.) as well as psychometric measures will be collected at baseline (prior to intervention) and endline (post intervention). All participants below 18 years of age will only be recruited after parental consent and self-assent.
- Masking
- None (open label)
- Enrolment
- 363 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, Christian Hospital Chhatarpur
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474312
- Sponsor's protocol ID
- STUDY23040073
- Other IDs
- 5D43TW009114-10
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2024
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Examine the Feasibility, Relevance, and Effectiveness of the Tool "Nae Disha for Life" Module in Reducing Suicide Ideation Among Young People in Bundelkhand Region of Madhya Pradesh, India
- ClinicalTrials.gov ID
- NCT06474312
- Acronym / sponsor ID
- STUDY23040073
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Keywords
- Nai Dish, Suicide ideation, Cue based, suicide attempts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Christian Hospital Chhatarpur
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is Cluster Randomized Control Trial research to examine feasibility and relevance of the modified tool Nae Disha for Life, which will incorporate suicide prevention and resilience to reduce suicide ideation among young people in Bundelkhand region of Madhya Pradesh, India. This intervention will build on existing relationships with at least four Government Middle Schools in Nowgong block of Chhatarpur district, Madhya Pradesh. This preliminary research will develop relationships and evidence for implementation scale-up research.
Detailed description
Madhya Pradesh state in India was ranked as third highest number of suicides reported in 2020 in India. The majority of suicide victims (23.4%) (35,771) were educated up to Matriculation/ Secondary level. A large proportion of suicide deaths occur between the ages 15 and 29. Mental health problems begin during youth (12-24) years of age, however, is often detected later in life.
"Nae Disha for Life" is a brief, multi-component, psychosocial promotion and resilience tool developed by Emmanuel Hospital Association, New Delhi. The purpose of this research work is to evaluate the feasibility, acceptance, and effectiveness of "Nae Disha for Life" tool in reducing suicide ideation among youth in Bundelkhand region. This will be implemented among the targeted schools of Nowgong block, Chhatarpur district.
There are number of studies on treatment gaps for the mental health problems, suicide statistical analysis, methods of suicides, and causes of suicides. But there is hardly any study on prevention of suicides or suicidal ideation among the youth in India.
However, Nae Disha is a youth resilience group-based intervention building on the Ottawa health promotion charter, that aims to increase and strengthen key psycho-social assets in adolescents to moderate the impacts of adversity. It has been successfully implemented amongst out-of-school adolescents in Northern India and studies have demonstrated effectiveness in improving perceptions of social inclusion, attitudes to gender equality, resilience, and mental health among young people affected by mental illness. The Nae Disha would also deliver benefits to other young people similarly affected in other parts of India, and possibly beyond.
Building on these studies, I propose to examine feasibility and relevance of the modified tool Nae Disha for Life, which will incorporate suicide prevention and resilience to reduce suicide ideation among young people in Bundelkhand region of Madhya Pradesh. This intervention will build on existing relationships with at least four Government Middle Schools in Nowgong block of Chhatarpur district, Madhya Pradesh. This preliminary research will develop relationships and evidence for implementational scale-up research.
The research activities of the study is distributed as follows:
4 months(16weeks), Training of surveyors, Training staff as Facilitators, Meeting with local, stakeholders / communities, Refinement of program content.
Next two weeks:Recruiting of subjects from 4 schools, Screening of subjects in 4 schools, Formation of groups in 4 schools,Baseline data collection from subjects,
18 weeks (Week 17-to week 34):Intensive implementation in intervention arm and control arm in 4 schools 2 (Week 35-36) weeks:Endline quantitative and qualitative data collection 6 weeks(week 37-week:43) Data entry, analysis and presentation of data findings After week 43: Dissemination meetings to be held at in schools and Chhatarpur
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a Cluster Randomized Control Trial (CRCT) research / study. The selection and approval of 64 Government schools was obtained will be done by the local PI based on comparable demographics (i.e. similar levels of socio-economic status) in the Nowgong block of Chhatarpur district. Two of the four schools will receive the intervention (intervention arm) and the other two will be the control arm. A sample size of n = 170 young people in each arm will be recruited from participating schools who are studying in 7th and 8th classes, aged between 12 - 17 years old. Sample size was calculated using optimal design software. The demographic data (e.g. age, father and mother completed years of education, caste, religion, etc.) as well as psychometric measures will be collected at baseline (prior to intervention) and endline (post intervention). All participants below 18 years of age will only be recruited after parental consent and self-assent.
| Arm | Type | Receives |
|---|---|---|
| Intervention Nae Disha | Experimental | Behavioral: Nae Disha"Nae Disha for Life" is a brief, multi-component, psychosocial promotion and resilience tool developed by Emmanuel Hospital Association, New Delhi. The purpose of this research work is to evaluate the feasibility, acceptance, and effectiveness of "Nae Disha for Life" tool in reducing suicide ideation among youth in Bundelkhand region. This will be implemented among the targeted schools of Nowgong block, Chhatarpur district. |
| Control arm | No intervention | –The control arm will not get any intervention, |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students of 7th and 8th classes of selected schools between 12 - 17 years old age group,
Key exclusion criteria (3 listed)
- a. Students who are planning to move to other schools during intervention period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nae Disha"Nae Disha for Life" is a brief, multi-component, psychosocial promotion and resilience tool developed by Emmanuel Hospital Association, New Delhi. The purpose of this research work is to evaluate the feasibility, acceptance, and effectiveness of "Nae Disha for Life" tool in reducing suicide ideation among youth in Bundelkhand region. This will be implemented among the targeted schools of Nowgong block, Chhatarpur district. | Behavioural | Intervention Nae Disha |
Primary outcome
Self-Reporting Questionnaire-20 (SRQ-20) Score
Time frame: Baseline and after 18 weeks of intervention (Nae Disha modules)
Mental health was assessed using the Self-Reporting Questionnaire-20 (SRQ-20). The SRQ-20 measures general psychiatric symptomatology. Total scores range from 0 to 20, with higher scores indicating worse mental health or more severe symptoms
Beck Depression Inventory-II (BDI-II) Score
Time frame: Baseline and after 18 weeks of intervention
Beck Depression Inventory-II (BDI-II): The BDI-II is a widely used self-report scale designed to assess the severity of depressive symptoms. It consists of 21 items, each scored on a scale from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate greater severity of depression and therefore represent a worse outcome.
Beck Scale for Suicidal Ideation (BSS) Score
Time frame: Baseline and after 18 weeks of intervention (Nae Disha modules)
Beck Scale for Suicidal Ideation (BSS): The BSS is a self-report scale used to assess the severity of suicidal ideation. It consists of 21 items, each scored on a scale from 0 to 2, with a total score typically ranging from 0 to 38 based on the first 19 items. Higher scores indicate greater severity of suicidal thoughts and therefore represent a worse outcome.
Brief Resilience Scale Score
Time frame: Baseline and after 18 weeks of intervention (Nae Disha modules)
Connor-Davidson Resilience Scale-10 (CD-RISC-10): The CD-RISC-10 is a self-report scale used to assess psychological resilience. It consists of 10 items, each scored on a scale from 0 to 4, with a total score ranging from 0 to 40. Higher scores indicate greater resilience and therefore represent a better outcome.
Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline and after 18 weeks of intervention (Nae Disha Modules)
Generalized Anxiety Disorder-7 (GAD-7): The GAD-7 is a self-report scale used to assess the severity of generalized anxiety disorder. It consists of 7 items, each scored on a scale from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate greater severity of anxiety and therefore represent a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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?
A study testing Nae Disha in people with Suicidal Ideation and Suicide, Attempted, 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 1 inclusion and 3 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 4 Sep 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?
Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Reporting Questionnaire-20 (SRQ-20) Score (time frame: Baseline and after 18 weeks of intervention (Nae Disha modules)). The study lists 5 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 4 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.