Reducing Suicide Ideation Among Young People

NCT06474312 | Active Not Recruiting

• 2 other identifiers: STUDY230400735D43TW009114-10
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide, Attempted

Keywords

Nai Dish; Suicide ideation; Cue based; suicide attempts

Outcome Measures

Primary Outcomes (4)

• Suicide ideation

  To study change in suicide ideation in intervention group measured by Beck Suicidal Ideation Scale as compared to control group. The total score ranges from 0 to 38.More score means higher suicide ideation.

  Baseline and after 18 weeks of intervention

• Hopelessness

  To study change in hopelessness in intervention group measured by Beck Hopelessness Scale as compared to control group. The score ranges from 0 to 20.

  Baseline and after 18 weeks of intervention

• Generalized anxiety

  To study change in generalized anxiety in intervention group measured by Generalized Anxiety Disorder Scale as compared to control group

  Baseline and after 18 weeks of intervention

• Resilience

  To study change in resilience in intervention group measured by Connor-Davidson Resilience Scale as compared to control group

  Baseline and after 18 weeks of intervention

Study Arms (2)

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.

Behavioral: Nae Disha

Control arm

NO INTERVENTION

The control arm will not get any intervention,

Interventions

Nae Disha BEHAVIORAL

"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.

Intervention Nae Disha

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Christian Hospital Chhatarpur: collaborator

Study Sites (1)

Christian Hospital, Mahoba Road

Chhatarpur, Madhya Pradesh, 471001, India

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Vishwajit L Nimgaonkar

  University of Pittburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: August 1, 2023
• Primary Completion: February 26, 2025
• Study Completion: March 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of this study
• Access Criteria: For individual participant data, meta-analysis

Locations

IN (1)