| CTRI Number |
CTRI/2022/09/045451 [Registered on: 13/09/2022] Trial Registered Prospectively |
| Last Modified On: |
12/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Youth-Centred Mental Health Transformation Through Gratitude, Kindness and Hope |
|
Scientific Title of Study
|
Effectiveness Of Interventions On Gratitude, Kindness And Hope To Enhance Mental Well-Being Among Adolescents In School And Community Settings In South India : A Cluster Randomised Controlled Trial. |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thara R |
| Designation |
Vice - Chairman |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychiatry Schizophrenia Research Foundation
R/7A, North Main Road,
Anna Nagar West Extension
Chennai
TAMIL NADU
6000101
India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Thara R |
| Designation |
Vice - Chairman |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychiatry Schizophrenia Research Foundation
R/7A, North Main Road,
Anna Nagar West Extension
Chennai
TAMIL NADU
6000101
India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Thara R |
| Designation |
Vice - Chairman |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychiatry Schizophrenia Research Foundation
R/7A, North Main Road,
Anna Nagar West Extension
Chennai
TAMIL NADU
6000101
India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
|
Source of Monetary or Material Support
|
| citiesRISE |
| Schizophrenia Research foundation |
|
|
Primary Sponsor
|
| Name |
citiesRISE |
| Address |
33 W 60th street FL2, New York, NY 10023 |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Schizophrenia Research Foundation |
R/7A, North Main Road, Anna Nagar West Extension
Chennai, Tamil Nadu
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Thara R |
Schizophrenia Research Foundation |
R/7A, North Main Road,
Anna Nagar West Extension
Chennai
TAMIL NADU |
9840238870
thara@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 |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Intervention on Teen Mental Health |
The Teen Mental Health Guide will be delivered over 8 sessions, fortnightly, for a duration of 45 minutes each. The intervention will be delivered by youth trainers, with 50% of the sessions, supervised by master trainers. |
| Intervention |
Core Intervention Focused on Gratitude, Kindness and Hope |
Arts based curriculum, focused on Gratitude, Kindness and Hope will be delivered over 8 sessions, fortnightly, for a duration of 45 minutes each. The interventions will be delivered by youth trainers, with 50% of the sessions, supervised by master trainers. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents in community clusters –
1) Adolescents between the ages of 12-14 will be recruited in the community matching the demographic and living within 5 kilometers of the community-based organization will be recruited
2) Parents in the community consent and the adolescent’s assent to participate in the program at the community-based organization
Adolescents in school clusters –
1) Students in grade 7-9 in schools that are demographically similar to the community clusters.
2) Participating schools and parents in schools provide consent and the adolescents assent to participate in the program at the schools
|
|
| ExclusionCriteria |
| Details |
1) Youth who are unable to provide informed assent due to problems related to any developmental disability including intellectual disability, Autism Spectrum Disorder.
2) Schools or communities less than 5kms away from each other will be excluded, to avoid, cross-contamination of participants
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| wellbeing |
Baseline,16 weeks and 28 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| kindness, gratitude and hope |
Baseline, 16 weeks and 28 weeks |
|
|
Target Sample Size
|
Total Sample Size="402"
Sample Size from India="402"
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)
|
15/09/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The research is a cluster randomized controlled trial aimed at demonstrating the effectiveness of enhancing mental wellbeing in children by improving character strengths of gratitude, kindness and hope by an arts-based youth delivered intervention as compared to enhanced control of delivering mental health literacy. The intervention is to create and deliver a curriculum of teaching gratitude, kindness and hope that has been contextualized for the local community by engaging with the local youth. The curriculum will use arts-based techniques including storytelling, psychodrama and creative arts to convey the curriculum material. Mental health research has thus far focused on mental illnesses rather than wellbeing and working with children between the ages of 12-14, there is a window of opportunity to develop the necessary life skills utilizing the character strengths and a positive psychological model to enhance the same. This work aligns itself to creating material that can be sustained at the grassroots levels that is directed towards enhancing knowledge and empowering youth to care for each other. |