| CTRI Number |
CTRI/2020/10/028542 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Phenomenological study and Content Validation |
| Study Design |
Other |
|
Public Title of Study
|
Development of an Occupational Therapy Module to Promote Mental Health in Adolescents |
|
Scientific Title of Study
|
Development and Validation of a School-Based Occupational Therapy Intervention for Mental Health Promotion among Adolescents |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhya Mariam Ninan |
| Designation |
Masters in Occupational Therapy - Mental Health and Psychosocial Rehabilitation |
| Affiliation |
Manipal University |
| Address |
Department of Occupational therapy, 3rd floor, Manipal College of Health Professions, MAHE.
Udupi
KARNATAKA
576104
India |
| Phone |
09620192639 |
| Fax |
|
| Email |
vidhyaninan173@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinita Acharya |
| Designation |
Associate Professor and Head |
| Affiliation |
Manipal College of Health Professionals, Manipal University |
| Address |
Department of Occupational therapy, 3rd floor, Manipal College of Health Professions, MAHE.
Udupi
KARNATAKA
576104
India |
| Phone |
9986071111 |
| Fax |
|
| Email |
vinita.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinita Acharya |
| Designation |
Associate Professor and Head |
| Affiliation |
Manipal College of Health Professionals, Manipal University |
| Address |
Department of Occupational therapy, 3rd floor, Manipal College of Health Professions, MAHE.
Udupi
KARNATAKA
576104
India |
| Phone |
9986071111 |
| Fax |
|
| Email |
vinita.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational therapy, Manipal College of Health Professionals, Kasturba Hospital |
|
|
Primary Sponsor
|
| Name |
Vidhya Mariam Ninan |
| Address |
Department of Occupational Therapy, 3rd floor, Manipal College of Health Professionals, MAHE |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vidhya Mariam Ninan |
Manipal University |
Department of Occupational Therapy, 3rd floor, Manipal College of Health Professionals, MAHE
Udupi
KARNATAKA |
9620192639
vidhyaninan173@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental Health Promotion among Adolescents |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for the stakeholders (Phase 1) –
1. Occupational therapists speaking English with minimum 3 year’s experience of working in mental health
2. Psychologists speaking English working with minimum 3 years of experience
3. High school teachers speaking English with minimum 3 year’s experience
4. 7th and 8th grade students
5. Parents with school going adolescent children who speak English.
Inclusion criteria for the expert panel (Phase 2)-
1. Occupational therapists speaking English with minimum 3 years experience of working in mental health
2. Psychologists speaking English working with minimum 3 years of experience
3. High school teachers speaking English with minimum 3 years experience |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop and validate a school-based occupational therapy intervention for mental health promotion among adolescents |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2020 |
| Date of Study Completion (India) |
30/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to develop and validate a school based occupational therapy intervention for mental health promotion. Phase 1 includes the Qualitative phase which will include interviews with various stakeholder such as teachers, psychologists, occupational therapists, parents. Focus group discussions will also be be conducted with 7th and 8th grade students as part of phase1. All the interviews will be conducted online via Microsoft teams With the information compiled from these interviews, a school-based occupational therapy intervention for mental health promotion will be made. Phase 2 includes content validation of this intervention that is formed. |