SPIRIT: A Suicide Prevention Project

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/04/008313
• Date of registration: 07-04-2017
• Prospective Registration: Yes
• Primary sponsor: National Institute of Mental Health
• Public title: SPIRIT: A Suicide Prevention Project
• Scientific title: SPIRIT - Suicide Prevention and Implementation Research Initiative - SPIRIT
• Date of first enrolment: 01-08-2018
• Target sample size: 120
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18256
• Study type: Interventional
• Study design: Cluster Randomized Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Bangladesh, India

Contacts

• Name: Dr Soumitra Pathare
• Affiliation: Indian Law Society

• Name: Dr Soumitra Pathare
• Affiliation: Indian Law Society

Key inclusion & exclusion criteria

Inclusion criteria: [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.


Exclusion criteria: [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.







Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Integrated suicide prevention intervention: Sub-intervention 1: The school-based suicide prevention program consists of a locally adapted version of the Youth Aware of Mental Health Program (YAMS). It is effective in reducing number of suicide rates by half among 14-15 year olds. YAMS 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. YAM is a manualized 5-hour program; the five-hour program is broken down into 3 hours of active roleplay sessions (which are crucial to engage students) with workshops, and 2 one-hour interactive lectures about mental health at the beginning and end of the intervention. 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
Sub-intervention 2: The second sub-intervention consists of reducing access to means of suicides through safe storage of pesticides in communities. This strategy 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 primary health workers in identifying, treating or referring persons at high-risk of suicides, from the communities to the nearest health care centers.
Intervention2: Integrated Suicide Prevention Intervention: Randomisation will be at the village level, with 60 villages randomised to intervention and 60 villages ra

Primary Outcome(s)

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 CHWâ??s and no. of persons referred by trained CHW to mental health professionals for suicidal ideation

Timepoint: 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(s)

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)



Timepoint: 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

Secondary ID(s)

NIL

Source(s) of Monetary Support

National Institute of Mental Health, Science Writing, Press, and Dissemination Branch 6001 Executive Boulevard, Room 6200, MSC 9663 Bethesda, MD 20892-9663, USA.

Ethics review

Status: Approved
Approval date: 02/03/2018
Contact:

IRB # 1 of Indian Law Society