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Reducing Suicide Ideation Among Young People

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06474312
Enrollment
363
Registered
2024-06-25
Start date
2023-08-01
Completion date
2026-03-31
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation, Suicide, Attempted

Keywords

Nai Dish, Suicide ideation, Cue based, suicide attempts

Brief 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. 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

Interventions

BEHAVIORALNae 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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER
Fogarty International Center of the National Institute of Health
CollaboratorNIH
Christian Hospital Chhatarpur
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Students of 7th and 8th classes of selected schools between 12 - 17 years old age group,

Exclusion criteria

* a. Students who are planning to move to other schools during intervention period b. Students of 7th/8th grade who turn 18 during the study. c. 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.

Design outcomes

Primary

MeasureTime frameDescription
Self-Reporting Questionnaire-20 (SRQ-20) ScoreBaseline 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) ScoreBaseline and after 18 weeks of interventionBeck 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) ScoreBaseline 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 ScoreBaseline 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) ScoreBaseline 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.

Countries

India

Contacts

PRINCIPAL_INVESTIGATORVishwajit L Nimgaonkar

University of Pittburgh

Participant flow

Recruitment details

This is a Cluster Randomized Controlled design. Participants were recruited from 6 government schools with similar demographics. Consented participants (n=175) from three schools were assigned to the Intervention Group, and participants (n=188) from other three schools were assigned to the Control Group. Started: Total participants=363 recruited. Completed Study: 173+186=359, Not Completed: 4 (Migrated with parents for labour work).

Pre-assignment details

All eligible students consented to participate, and all participating students were recruited.

Baseline characteristics

Characteristic
Age, Customized
Age groups
12 to 13 years
299 Participants
Age, Customized
Age groups
14 to 15 years
60 Participants
Age, Customized
Age groups
16 to 17 years
4 Participants
Below-Poverty Line Family Card
Don't know
101 Participants
Below-Poverty Line Family Card
No/Don't Have Below Povery line card
58 Participants
Below-Poverty Line Family Card
Yes/Have Below Povery Line Card
107 Participants
Caste
General Caste
8 Participants
Caste
Other Backward Caste
263 Participants
Caste
Schedule Caste
62 Participants
Class in School
Eighth grade
175 Participants
Class in School
Seventh grade
90 Participants
Class in School
Sixth grade
9 Participants
Education of father
Class 10 completed
87 Participants
Education of father
Class 12 completed
11 Participants
Education of father
Class 5 completed
77 Participants
Education of father
Class 8 completed
107 Participants
Education of father
Diploma
2 Participants
Education of father
Graduate
3 Participants
Education of father
Illiterate/ Never been to school
65 Participants
Education of mother
Class 10 completed
9 Participants
Education of mother
Class 12 completed
6 Participants
Education of mother
Class 5 completed
67 Participants
Education of mother
Class 8 completed
50 Participants
Education of mother
Illiterate/ Never been to school
104 Participants
Family run out of money for food or essentials last month
No
277 Participants
Family run out of money for food or essentials last month
Yes
66 Participants
Number of children aged 5- 18 in the family attending school regularly3 children
Number of children in the family aged 5 - 18 years3 children
Number of days of school missed in last 3 months10 Number of Days
Race and Ethnicity Not Collected0 Participants
Religion
Hindu
188 Participants
Religion
Muslim
4 Participants
Sex: Female, Male
Female
98 Participants
Sex: Female, Male
Male
73 Participants
Type of house
Don't know
8 Participants
Type of house
Kaccha house
32 Participants
Type of house
Pucca house
107 Participants
Type of house
Semi-pucca house
78 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1750 / 188
other
Total, other adverse events
0 / 1750 / 188
serious
Total, serious adverse events
0 / 1750 / 188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026