Trial Outcomes & Findings for Reducing Suicide Ideation Among Young People (NCT NCT06474312)
NCT ID: NCT06474312
Last Updated: 2026-09-04
Results Overview
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
COMPLETED
NA
363 participants
Baseline and after 18 weeks of intervention (Nae Disha modules)
2026-09-04
Participant Flow
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).
All eligible students consented to participate, and all participating students were recruited.
Unit of analysis: Schools
Participant milestones
| Measure |
Intervention 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 the "Nae Disha for Life" tool in reducing suicide ideation among participating youth in the Nowgong block, Chhatarpur district.
|
Control Arm
The control arm will not get any intervention
|
|---|---|---|
|
Overall Study
STARTED
|
175 3
|
188 3
|
|
Overall Study
COMPLETED
|
173 3
|
186 3
|
|
Overall Study
NOT COMPLETED
|
2 0
|
2 0
|
Reasons for withdrawal
| Measure |
Intervention 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 the "Nae Disha for Life" tool in reducing suicide ideation among participating youth in the Nowgong block, Chhatarpur district.
|
Control Arm
The control arm will not get any intervention
|
|---|---|---|
|
Overall Study
Migrated with parents for labour work
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Nae Disha
n=3 Schools
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 the "Nae Disha for Life" tool in reducing suicide ideation among participating youth in the Nowgong block, Chhatarpur district.
|
Control Arm
n=3 Schools
The control arm will not get any intervention.
|
Total
n=6 Schools
Total of all reporting groups
|
|---|---|---|---|
|
Class in School
Sixth grade
|
9 Participants
n=175 Participants
|
0 Participants
n=188 Participants
|
9 Participants
n=363 Participants
|
|
Class in School
Seventh grade
|
89 Participants
n=175 Participants
|
90 Participants
n=188 Participants
|
179 Participants
n=363 Participants
|
|
Class in School
Eighth grade
|
77 Participants
n=175 Participants
|
98 Participants
n=188 Participants
|
175 Participants
n=363 Participants
|
|
Number of days of school missed in last 3 months
|
15 Number of Days
n=175 Participants
|
10 Number of Days
n=188 Participants
|
12 Number of Days
n=363 Participants
|
|
Number of children in the family aged 5 - 18 years
|
3 children
n=175 Participants
|
3 children
n=188 Participants
|
3 children
n=363 Participants
|
|
Number of children aged 5- 18 in the family attending school regularly
|
3 children
n=175 Participants
|
2 children
n=188 Participants
|
2 children
n=363 Participants
|
|
Education of father
Class 12 completed
|
11 Participants
n=175 Participants
|
11 Participants
n=188 Participants
|
22 Participants
n=363 Participants
|
|
Type of house
Kaccha house
|
28 Participants
n=175 Participants
|
32 Participants
n=188 Participants
|
60 Participants
n=363 Participants
|
|
Type of house
Semi-pucca house
|
100 Participants
n=175 Participants
|
78 Participants
n=188 Participants
|
178 Participants
n=363 Participants
|
|
Type of house
Pucca house
|
39 Participants
n=175 Participants
|
68 Participants
n=188 Participants
|
107 Participants
n=363 Participants
|
|
Type of house
Don't know
|
8 Participants
n=175 Participants
|
10 Participants
n=188 Participants
|
18 Participants
n=363 Participants
|
|
Below-Poverty Line Family Card
No/Don't Have Below Povery line card
|
97 Participants
n=175 Participants
|
58 Participants
n=188 Participants
|
155 Participants
n=363 Participants
|
|
Below-Poverty Line Family Card
Yes/Have Below Povery Line Card
|
45 Participants
n=175 Participants
|
62 Participants
n=188 Participants
|
107 Participants
n=363 Participants
|
|
Below-Poverty Line Family Card
Don't know
|
33 Participants
n=175 Participants
|
68 Participants
n=188 Participants
|
101 Participants
n=363 Participants
|
|
Family run out of money for food or essentials last month
No
|
155 Participants
n=175 Participants
|
122 Participants
n=188 Participants
|
277 Participants
n=363 Participants
|
|
Family run out of money for food or essentials last month
Yes
|
20 Participants
n=175 Participants
|
66 Participants
n=188 Participants
|
86 Participants
n=363 Participants
|
|
Education of mother
Illiterate/ Never been to school
|
48 Participants
n=175 Participants
|
56 Participants
n=188 Participants
|
104 Participants
n=363 Participants
|
|
Education of mother
Class 5 completed
|
54 Participants
n=175 Participants
|
67 Participants
n=188 Participants
|
121 Participants
n=363 Participants
|
|
Education of mother
Class 8 completed
|
49 Participants
n=175 Participants
|
50 Participants
n=188 Participants
|
99 Participants
n=363 Participants
|
|
Education of mother
Class 10 completed
|
20 Participants
n=175 Participants
|
9 Participants
n=188 Participants
|
29 Participants
n=363 Participants
|
|
Education of mother
Class 12 completed
|
4 Participants
n=175 Participants
|
6 Participants
n=188 Participants
|
10 Participants
n=363 Participants
|
|
Education of father
Illiterate/ Never been to school
|
22 Participants
n=175 Participants
|
43 Participants
n=188 Participants
|
65 Participants
n=363 Participants
|
|
Education of father
Class 5 completed
|
33 Participants
n=175 Participants
|
44 Participants
n=188 Participants
|
77 Participants
n=363 Participants
|
|
Education of father
Class 8 completed
|
67 Participants
n=175 Participants
|
40 Participants
n=188 Participants
|
107 Participants
n=363 Participants
|
|
Education of father
Class 10 completed
|
41 Participants
n=175 Participants
|
46 Participants
n=188 Participants
|
87 Participants
n=363 Participants
|
|
Age, Customized
Age groups · 12 to 13 years
|
143 Participants
n=175 Participants
|
156 Participants
n=188 Participants
|
299 Participants
n=363 Participants
|
|
Age, Customized
Age groups · 14 to 15 years
|
31 Participants
n=175 Participants
|
29 Participants
n=188 Participants
|
60 Participants
n=363 Participants
|
|
Age, Customized
Age groups · 16 to 17 years
|
1 Participants
n=175 Participants
|
3 Participants
n=188 Participants
|
4 Participants
n=363 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=175 Participants
|
98 Participants
n=188 Participants
|
200 Participants
n=363 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=175 Participants
|
90 Participants
n=188 Participants
|
163 Participants
n=363 Participants
|
|
Education of father
Diploma
|
0 Participants
n=175 Participants
|
2 Participants
n=188 Participants
|
2 Participants
n=363 Participants
|
|
Education of father
Graduate
|
1 Participants
n=175 Participants
|
2 Participants
n=188 Participants
|
3 Participants
n=363 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Religion
Hindu
|
171 Participants
n=175 Participants
|
188 Participants
n=188 Participants
|
359 Participants
n=363 Participants
|
|
Religion
Muslim
|
4 Participants
n=175 Participants
|
0 Participants
n=188 Participants
|
4 Participants
n=363 Participants
|
|
Caste
General Caste
|
8 Participants
n=175 Participants
|
3 Participants
n=188 Participants
|
11 Participants
n=363 Participants
|
|
Caste
Other Backward Caste
|
140 Participants
n=175 Participants
|
123 Participants
n=188 Participants
|
263 Participants
n=363 Participants
|
|
Caste
Schedule Caste
|
27 Participants
n=175 Participants
|
62 Participants
n=188 Participants
|
89 Participants
n=363 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 18 weeks of intervention (Nae Disha modules)Population: 4 Participants (2 from each group) dropped out or were excluded (Migrated with parents for labor work).
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
Outcome measures
| Measure |
Intervention Nae Disha
n=175 Participants
"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
n=188 Participants
The control arm will not get any intervention,
|
|---|---|---|
|
Self-Reporting Questionnaire-20 (SRQ-20) Score
Baseline
|
3 score on a scale
Interval 1.0 to 7.0
|
4 score on a scale
Interval 1.0 to 8.0
|
|
Self-Reporting Questionnaire-20 (SRQ-20) Score
Endline (after 18 weeks of intervention)
|
1 score on a scale
Interval 0.0 to 3.0
|
4 score on a scale
Interval 1.25 to 6.0
|
PRIMARY outcome
Timeframe: Baseline and after 18 weeks of interventionPopulation: 4 Participants (2 from each group) dropped out or were excluded (Migrated with parents for labor work).
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.
Outcome measures
| Measure |
Intervention Nae Disha
n=175 Participants
"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
n=188 Participants
The control arm will not get any intervention,
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II) Score
Baseline
|
9 Score
Interval 3.0 to 18.0
|
5 Score
Interval 0.75 to 19.0
|
|
Beck Depression Inventory-II (BDI-II) Score
Endline (after 18 weeks of intervention)
|
3 Score
Interval 1.0 to 5.0
|
7 Score
Interval 1.0 to 18.0
|
PRIMARY outcome
Timeframe: Baseline and after 18 weeks of intervention (Nae Disha modules)Population: 4 Participants (2 from each group) dropped out or were excluded (Migrated with parents for labor work).
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.
Outcome measures
| Measure |
Intervention Nae Disha
n=175 Participants
"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
n=188 Participants
The control arm will not get any intervention,
|
|---|---|---|
|
Beck Scale for Suicidal Ideation (BSS) Score
Baseline
|
0 Score
Interval 0.0 to 3.0
|
0 Score
Interval 0.0 to 2.0
|
|
Beck Scale for Suicidal Ideation (BSS) Score
Endline (after 18 weeks of intervention)
|
0 Score
Interval 0.0 to 0.0
|
0 Score
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Baseline and after 18 weeks of intervention (Nae Disha modules)Population: 4 Participants (2 from each group) dropped out or were excluded (Migrated with parents for labor work).
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.
Outcome measures
| Measure |
Intervention Nae Disha
n=175 Participants
"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
n=188 Participants
The control arm will not get any intervention,
|
|---|---|---|
|
Brief Resilience Scale Score
Baseline
|
8 Score
Interval 6.0 to 11.0
|
10 Score
Interval 0.0 to 10.25
|
|
Brief Resilience Scale Score
Endline (after 18 weeks of intervention)
|
30 Score
Interval 30.0 to 32.0
|
12 Score
Interval 8.0 to 16.75
|
PRIMARY outcome
Timeframe: Baseline and after 18 weeks of intervention (Nae Disha Modules)Population: 4 Participants (2 from each group) dropped out or were excluded (Migrated with parents for labor work).
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.
Outcome measures
| Measure |
Intervention Nae Disha
n=175 Participants
"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
n=188 Participants
The control arm will not get any intervention,
|
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7) Score
Baseline
|
13 Score
Interval 12.0 to 15.0
|
12 Score
Interval 10.0 to 15.0
|
|
Generalized Anxiety Disorder-7 (GAD-7) Score
Endline (after 18 weeks of intervention)
|
3 Score
Interval 2.0 to 6.0
|
14 Score
Interval 11.0 to 16.0
|
Adverse Events
Intervention Nae Disha
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place