| CTRI Number |
CTRI/2024/05/067591 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Development and testing the effectiveness of SEWA-PMI module for nurturing wellbeing of adolescents in families with mental illness |
|
Scientific Title of Study
|
Development of social and emotional wellbeing module for adolescents with parents with mental illness - A Pilot Study |
| Trial Acronym |
SEWA-PMI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Kerketta |
| Designation |
Phd Scholar |
| Affiliation |
LGB Institute of Mental Health |
| Address |
Department of PSW, LGB Regional Institute of Mental health Tezpur- Assam
Sonitpur
ASSAM
-784001
India |
| Phone |
6003069387 |
| Fax |
|
| Email |
Sushmitakerketta8@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia P Deuri |
| Designation |
HOD, Department of Psychiatric Social Work |
| Affiliation |
LGB Regional Institute of Mental Health , Tezpur, Assam |
| Address |
Department of Psychiatric Social Work-LGB Institute of Mental health - Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9435080843 |
| Fax |
|
| Email |
soniadeuri28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sobhana H |
| Designation |
Associate Professor, Department of Psychiatric Social Work |
| Affiliation |
LGB Regional Institute of Mental health |
| Address |
Department of Psychiatric Social Work- LGB Institute of Mental health - Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9435183606 |
| Fax |
|
| Email |
sobhana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self Funded |
| Address |
Department of Psychiatric Social Work, LGB Regional Institute of Mental health- Tezpur Assam |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ms Sushmita Kerketta |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur |
Department of Psychiatric Social Work, 4th floor, Academic Building
Sonitpur
ASSAM |
6003069387
Sushmitakerketta8@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LGB Regional Institute of Mental Health- Tezpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents between 12-17 years with one parent diagnosed with mental illness -Schizophrenia, Bipolar Affective Disorder, Obsessive Compulsive disorder, Recurrent Depressive Disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
SEWA- PMI |
The Study is a quasi experimental designed research, with one group pre-post test in two time stand points, which is after 1 month and 3 months of the completion of the sessions. The intervention would focus on maintenance of emotional and social wellbeing of adolescents with parents diagnosed with mental illness. The study is three phased, where in the first phase need assessment and item generation would be done, in the second phase the module based intervention would be developed and in the third phase the module would be tested in a single group. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
They must have 1 parent diagnoised with mental illness, They should be school-going, and must
have a minimum qualification of 5th
standard, must be living with the ill parent for more than 2 years, should score 16 and above on Kesselers Psychological distress scale. |
|
| ExclusionCriteria |
| Details |
Adolescents diagnoised with psychotic illness and if both parents are diagnoised with mental illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The module would help such adolescents reduce distress, increase their self-esteem and wellbeing in the psychological, social and emotional aspects. |
post assessment will be done in two times points, 1st would be done in 1 month after completion of intervention, 2nd would be done after completion of 3 months of time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase their awareness about their parents condition, mental health and make them better functioning adults |
Post assessment will be done in two times points, 1st would be done in 1 month after |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="2"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included nil).
- For how long will this data be available start date provided 01-03-2025 and end date provided 30-09-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Study Title: Development of Social and Emotional Well-being Module for Adolescents with Parents Mental Illness
(SEWA- PMI): A Pilot Study
The study aims in developing an
intervention module for the well-being of adolescents growing up with parents facing mental illness. Methodology: In the first phase of the study the researcher will use an exploratory qualitative research design,
by conducting in-depth interviews with 10 adolescents of parents with mental illness. The process will further
involve conducting of FGD with 10 well-parents of the adolescent and 10 adults with experiences of growing up
with parent with mental illness. Thematic analysis would be used to analyze the transcripts. In the second phase of
the study the researcher would develop the module and validate it by 10 mental health professionals, through
Delphi method. In the third phase, the researcher will use single group pre-test-post-test design with 12
adolescents with parents with mental illness. Pre and Post assessment would be done in three time-stand point - 1
pre-assessment before initiating the intervention, 1st post-assessment after 1 month and 2nd post assessment after 3
month of completion of the intervention. Tools that would be used are: Kessler Psychological Distress Scale (K10),
Rosenberg Self-esteem Scale, Mental Health Continuum Short Form (Adolescent MHC-SF). The changes in
domains of emotional wellbeing, social wellbeing, psychological wellbeing, self-esteem and distress will be
analyzed with Repeated Measures of analysis of variance (RM ANOVA).
Results: Conclusion : There would be significant difference in overall level of distress, self-esteem, psychological, social and
emotional wellbeing |