| CTRI Number |
CTRI/2017/04/008313 [Registered on: 07/04/2017] Trial Registered Prospectively |
| Last Modified On: |
30/10/2019 |
| 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
|
|
|
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
|
|
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 |
14.00 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 (14-16 years old) 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 |
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. |