- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06474312
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madhya Pradesh
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Chhatarpur, Madhya Pradesh, India, 471001
- Christian Hospital, Mahoba Road
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 "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.
|
"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.
|
|
No Intervention: Control arm
The control arm will not get any intervention,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and after 18 weeks of intervention
|
|
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
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Baseline and after 18 weeks of intervention
|
|
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.
|
Baseline and after 18 weeks of intervention
|
|
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.
|
Baseline and after 18 weeks of intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vishwajit L Nimgaonkar, University of Pittburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23040073
- 5D43TW009114-10 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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