| CTRI Number |
CTRI/2024/11/077384 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Juveniles Accessing Mental Health Services: A novel method of enhancing the wellbeing of children in the Juvenile Justice System |
|
Scientific Title of Study
|
Juveniles Accessing Mental Health Services: Transition to Scale Project |
| Trial Acronym |
JAMS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Padmavati |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation (India) |
| Address |
R/7A, North Main Road, Anna Nagar (west), Chennai
Chennai TAMIL NADU 600101 India |
| Phone |
04426153971 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr R Padmavati |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation (India) |
| Address |
R/7A, North Main Road, Anna Nagar (west), Chennai
Chennai TAMIL NADU 600101 India |
| Phone |
04426153971 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Shiva Prakash Srinivasan |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Schizophrenia Research Foundation (India) |
| Address |
R/7A, North Main Road, Anna Nagar (west), Chennai
Chennai TAMIL NADU 600101 India |
| Phone |
04426153971 |
| Fax |
|
| Email |
shivaprakash@scarfindia.org |
|
|
Source of Monetary or Material Support
|
| Grand Challenges Canada, MaRS Centre, West Tower, 661 University Avenue, Suite 1720, Toronto, ON M5G 1M1 |
|
|
Primary Sponsor
|
| Name |
Grand Challenges Canada |
| Address |
MaRS Centre, West Tower
661 University Avenue, Suite 1720
Toronto, ON M5G 1M1 |
| Type of Sponsor |
Other [International Funding Agency] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiva Prakash Srinivasan |
Schizophrenia Research Foundation (India) |
Department of Youth Mental Health, R/7A, North Main Road, Anna Nagar (West) Chennai TAMIL NADU |
9380055736
shivaprakash@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of SCARF |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers and screened individuals with identified disorders under ICD 10 classification Category F |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Development of Youth Friendly Spaces (YFS) |
The YFS intends to provide a safe and friendly space for the children in the CCIs to learn about caring for their mental health and wellbeing and seek help when needed. Co-development of the space will involve the staff and management of the CCIs to determine the logistics of creating and running the space. Following this, children identified by the staff as being a positive influence on the other children and older children who volunteer to run the space will be trained in providing peer support. They will be tasked with negotiating with the staff and administration on running the YFS. The children and the staff will also be provided access to the YFS manual created during phase 1 of the JAMS project to engage the children in activities in the YFS.
The Duration of said intervention will be monthly once for 12 months |
| Intervention |
Mental health literacy Training |
We will identify master trainers from the government and non-governmental bodies. These master trainers will undergo detailed mental health literacy module training and deliver them to the other staff within their CCIs. The members of the DCPU and CWC will also deliver the modules to the staff from other CCIs. Implementing training through the ToT model ensures that staff change does not prove to be an obstacle to the programs sustainability.
The total duration of this intervention will be for 6 sessions over a six week period |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Screening and Referral for Mental health services |
In this component, the staff will be trained in the identification and assessment of mental health issues among children. They will also be provided with standardized screening tools and taught how to use them. A reference list of available local mental health services will be created. Additionally, we will scope the district for all available mental health services, including outpatient mental health providers and providers in the government system, so that the staff can access many providers. This will support further scaleup of the referral for mental health services.
This will be done once at the beginning of the study. The referral service provision will be ongoing. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
- Children living in Childcare institutions registered under the Juvenile Justice (Care and Protection) Act of 2015
- Includes both Children in Need of Care and Protection and Children in Conflict with the Law |
|
| ExclusionCriteria |
| Details |
- The children living in Childcare institutions which do not consent to participating in the study
- Children who do not provide assent to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Screen 650 children in CCIs
Train 40 master trainers across 8 districts in Tamil Nadu and Odisha
Improvement in wellbeing of children receiving intervention |
Baseline and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in social connectedness among children |
Baseline and six months |
|
|
Target Sample Size
|
Total Sample Size="650" Sample Size from India="650"
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)
|
02/12/2024 |
| 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="1" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Juveniles Accessing Mental
health Services (JAMS) project was conceived and implemented between April 2021
to September 2023 by funding from the Grand Challenges Canada’s Proof of
Concept funding. The JAMS Project, was specifically designed for children aged
12-18 in childcare institutions (CCIs). There is sufficient evidence that
children in CCIs face multiple adversities and are prone to mental health
problems. Despite this, these vulnerable children do not receive the
appropriate knowledge to care for their mental health. This unique intervention
empowers children and staff of CCIs with mental health knowledge, addressing
not only mental health problems but also enhancing their positive mental health.
A key component of the JAMS project is the creation and maintenance of Youth
Friendly Spaces (YFS), which are safe environments within CCIs where children
can learn and practice positive mental health skills in a non-judgmental
fashion. The final component involves screening and referring children
identified with mental health problems to appropriate mental health services.
The JAMS project, piloted in 7 CCIs across two
states in India, has shown remarkable results. It has significantly improved
the overall mental well-being of children in these CCIs. Children reported
lower stress levels and appreciated the referrals for mental health services.
Staff also noticed improvements in the children’s behavior and engagement with
each other. This part of the project aims to expand the project to evaluate the
sustainability and enhance the reach of the project to additional districts in
the two states. |