Skip to main content
Clinical Trials/NCT06474312
NCT06474312
Active, not recruiting
Not Applicable

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

University of Pittsburgh1 site in 1 country272 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Ideation
Sponsor
University of Pittsburgh
Enrollment
272
Locations
1
Primary Endpoint
Hopelessness
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
March 31, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vishwajit Nimgaonkar, MD PhD

Professor

University of Pittsburgh

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Hopelessness

Time Frame: Baseline and after 18 weeks of intervention

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.

Suicide ideation

Time Frame: Baseline and after 18 weeks of intervention

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.

Generalized anxiety

Time Frame: Baseline and after 18 weeks of intervention

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

Resilience

Time Frame: Baseline and after 18 weeks of intervention

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

Study Sites (1)

Loading locations...

Similar Trials