Clinical trial NCT06474312: Reducing Suicide Ideation Among Young People
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempted
Keywords: Nai Dish
Suicide ideation
Cue based
suicide attempts
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Christian Hospital Chhatarpur
First posted: 2024-06-25
Enrollment: 272
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Suicide ideation
timeFrame: Baseline and after 18 weeks of intervention
measure: Hopelessness
timeFrame: Baseline and after 18 weeks of intervention
measure: Generalized anxiety
timeFrame: Baseline and after 18 weeks of intervention
measure: Resilience
timeFrame: Baseline and after 18 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chhattarpur
country: India
facility: Christian Hospital, Mahoba Road
state: Madhya Pradesh
Study officials:
affiliation: University of Pittburgh
name: Vishwajit L Nimgaonkar
role: PRINCIPAL_INVESTIGATOR
References: