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CTRI Number  CTRI/2017/04/008313 [Registered on: 07/04/2017] Trial Registered Prospectively
Last Modified On: 18/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   SPIRIT: A Suicide Prevention Project 
Scientific Title of Study   SPIRIT - Suicide Prevention and Implementation Research Initiative 
Trial Acronym  SPIRIT  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soumitra Pathare 
Designation  Coordinator  
Affiliation  Indian Law Society 
Address  Centre for Mental Health Law and Policy, Indian Law Society, ILS Law College Campus, Law College Road, Pune.

Pune
MAHARASHTRA
411004
India 
Phone  02025656775  
Fax  02025658665  
Email  spathare@cmhlp.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumitra Pathare 
Designation  Coordinator 
Affiliation  Indian Law Society 
Address  Centre for Mental Health Law and Policy, Indian Law Society, ILS Law College Campus, Law College Road, Pune.

Pune
MAHARASHTRA
411004
India 
Phone  02025656775  
Fax  02025658665  
Email  spathare@cmhlp.org  
 
Details of Contact Person
Public Query  
Name  Dr Soumitra Pathare 
Designation  Coordinator 
Affiliation  Indian Law Society 
Address  Centre for Mental Health Law and Policy, Indian Law Society, ILS Law College Campus, Law College Road, Pune.

Pune
MAHARASHTRA
411004
India 
Phone  02025656775  
Fax  02025658665  
Email  spathare@cmhlp.org  
 
Source of Monetary or Material Support  
National Institute of Mental Health, Science Writing, Press, and Dissemination Branch 6001 Executive Boulevard, Room 6200, MSC 9663 Bethesda, MD 20892-9663, USA. 
 
Primary Sponsor  
Name  National Institute of Mental Health 
Address  Science Writing, Press, and Dissemination Branch 6001 Executive Boulevard, Room 6200, MSC 9663 Bethesda, MD 20892-9663 
Type of Sponsor  Other [U.S. Government ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soumitra Pathare  Mahesana District  120 Villages in Mahesana District, Gujarat
Mahesana
GUJARAT 		 9370666191
02025658665
spathare@cmhlp.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB # 1 of Indian Law Society  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Suicidal Ideation, Attempts of Suicide, Suicide 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Integrated Suicide Prevention Intervention  Randomisation will be at the village level, with 60 villages randomised to intervention and 60 villages randomised to control. Sub-intervention 1: The school-based suicide prevention program consists of a locally adapted version of Youth Aware of Mental Health Program (YAM). It is a manualized 5-hour program broken down into 3 hours of active roleplay sessions and workshops, and 2 one-hour interactive lectures about mental health at the beginning and end of the intervention in 60 intervention villages in Mahesana District. In addition, students receive a booklet on mental health issues and strategies to deal with difficult life events. Educational posters are available for each classroom; the themes of the posters related to mental health and suicide, in local language and adapted to the local setting in Gujarat by the SPIRIT team. YAM is designed to change perceptions among students about mental health as well as help improve coping skills to deal with stressful life events that can trigger suicidal behavior. It is effective in reducing severe suicidal ideation by half among 14-16 year olds. Sub-intervention 2: The second sub-intervention consists of reducing access to means of suicides – pesticides - by keeping them at a safe and centralized pesticide storage unit within the communities. In this intervention, researchers will liaise with the Department of Agriculture, Govt. of Gujarat to map location and sustainability of storage units. Researchers will also approach Panchayat Leaders to encourage local ownership over the storage facility’s introduction into the village. Each intervention village will receive one centralized storage unit, and villagers will be encouraged to use this facility. Keeping pesticides safely in a centralized storage has two distinct advantages: i) it reduces the storage of pesticides in homes; ii) it engages and involves the entire community, including the Panchayat leader, in the prevention of suicide. Sub-intervention 3: This sub-intervention consists of training healthcare workers to identify and treat persons with high-risk behavior, when and to whom to refer people with high risk-of suicide, and what kind of psychosocial support to provide at what stage. These health workers include health workers who work at primary care centers; community-based health workers (Anganwadi workers or Auxiliary Nurse midwives, both of whom provide basic health care at the village level) and lay health worker (Accredited Social Health Activists - ASHAs). The training will be based on WHO MhGAP intervention guide version 2.0. In capacity building component, SPIRIT team will train 40 implementation research fellows and policy makers from India and Bangladesh in designing and conducting implementation research and using the evidence in policy level decision making.  
Comparator Agent  Normal Practices  Comparison with Normal Practices 
 
Inclusion Criteria
Modification(s)  
Age From  13.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  [1] For a village to be included in the study it must meet the following inclusion criteria:
(i) A secondary school exists with more than 35 students.
(ii)The school has agreed to participate in the study.
(iii) Panchayat has approved the implementation of the community storage facility for pesticides.

[2]For Sub-intervention 1 (School based intervention), target population is of school-going adolescents from 9th standard, according to the Indian education system context. So, inclusion criteria for this Sub-intervention are -
(i) One parent of a child in 9th standard at school who provides written informed consent (or through thumbprint after verbal consent)
(ii) School-attending children from 9th standard who provide assent to participation in the school-based intervention.

[3] For Sub-intervention 2 (Community storage of pesticides), target population is of adults (head of the family). So, inclusion criterion for this Sub-intervention is adult members (ages 18-65) of families/households who are willing to participate in the intervention, who provide consent in writing (or through thumbprint after verbal consent) to having their usage data of storage boxes collected.

[4] For Sub-intervention 3 (Training of Community Health Workers), target population comprise Community health workers who work in Government Hospitals in Mahesana District. So the inclusion criteria for this Sub-intervention is -
(i) Any Community Health Worker (CHW) from 1 of the 3 categories - (1) Primary health care workers who work at primary care centers; (2) Community-based health workers (Anganwadi workers or Auxiliary Nurse midwives, both of whom provide basic health care at the village level); and (3) Lay health worker (Accredited Social Health Activists, also known as ASHAs.
(ii) CHWs who work in one of 60 intervention or control villages.
(iii) CHWs who are motivated to learn a new module and commit to (1) using the referral pathway they have been trained in, in routine practice as a CHW and; (2) commit to training other CHWs in their village and surrounding villages in the module.
 
 
ExclusionCriteria 
Details  [1] For Sub-intervention 1 (School based intervention), exclusion criteria are -
(i) Adolescents who do not assent,
(ii) Parents of the adolescent do not consent,
(iii) Adolescents who do not attend school,
(iv) Children who are unable to participate in YAM training due to severe learning disability.

[2] For Sub-intervention 2 (Community Storage of Pesticides), exclusion criteria are -
(i) Those who do not consent
(ii) Those who are under the age of 18 and over the age of 65 at the start of the study
(iii) Those who do not have or use pesticides.

[3] For Sub-intervention 3 (Training of Community Health Workers (CHW)), exclusion criteria are -
(i) Those who do not consent
(ii) Those who do not commit to using the new referral pathway (iii) Those who do not commit to training other CHW
(iv) Those who cannot or will not participate in all of the training.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Sub-int 1: Reduction in suicidal ideation 19% to 15% in intervention villages
Sub-int 2: 20% reduction of suicides and attempted suicides in intervention villages
Sub-int 3: No. of persons with suicidal ideation detected by trained CHW’s and no. of persons referred by trained CHW to mental health professionals for suicidal ideation
 		 Sub-int 1: 3 and 12 months
Sub-int 2: 12 months
Sub-int 3: Prior to start of the training, at the end of the last day of the training program, and 6 and 12 months after the training.
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Proportion of adolescents received YAMS program.
2.Proportion of schools that agreed to implement YAMS intervention of total number of schools approached.
3.Of the above, proportion of schools that implemented the program.
4.Proportion of villages that agreed to have the community storage boxes.
5.Of the above, villages actually gave space to build the storage boxes.
(other secondary outcomes continued in Brief Summary due to character limit)

 		 Secondary Outcome no. 1: 12 months
Secondary Outcome no. 2: 12 months
Secondary Outcome no. 3: 12 months
Secondary Outcome no. 4: 0 months onwards
Secondary Outcome no. 5: 0 months onwards
Secondary Outcome no. 6: 12 months
Secondary Outcome no. 7: 12 months
Secondary Outcome no. 8: 12 months
Secondary Outcome no. 9: 0 and post training
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nill 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Secondary Outcomes Continued:

6. Proportion of households reached with promotion activities linked to community storage of pesticides; Proportion of households requested a community storage box; Proportion of households received a community storage box.

7. Proportion of households in the villages that used the boxes regularly.

8. Proportion of health workers trained in intervention villages

9. Improvement in knowledge, attitudes and practice of CHW who received training

10. Number of community health workers actually applying knowledge and skills obtained through the training program in their day to day practice at 6 and 12-month follow-up.

 
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