| CTRI Number |
CTRI/2023/07/055453 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Building adolescence resilience] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Adapting an existing resilience program for school-going adolescents: An effectiveness study |
|
Scientific Title of Study
|
Effectiveness of resilience enhancement program for school-going adolescents |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krupa A L |
| Designation |
Ph D Scholar |
| Affiliation |
NIMHANS |
| Address |
Govindaswamy centre Department of Psychiatric Social Work Hosur main road Near dairy circle NIMHANS Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8971930704 |
| Fax |
|
| Email |
krupa10msw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janardhana N |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Psychiatric Social Work Govindaswamy center Hosur main road Near dairy circle NIMHANS Bengaluru Karnataka India
Department of Psychiatric Social Work Govindaswamy center Hosur main road Near dairy circle NIMHANS Bengaluru Karnataka India
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995238 |
| Fax |
|
| Email |
janardhannimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krupa A L |
| Designation |
Ph D Scholar |
| Affiliation |
NIMHANS |
| Address |
Govindaswamy centre Hosur main road Near dairy circle NIMHANS Bengaluru
Hosur main road NIMHANS Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8971930704 |
| Fax |
|
| Email |
krupa10msw@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neuro Sciences-NIMHANS |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [None] |
|
|
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 |
| Krupa A L |
Government High School |
Government High School, Doddachinnanahalli and Hulibele, Bangarpet rural, Kolar district, pincode-563114
Kolar
KARNATAKA |
8971930704
krupa10msw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Behavioral science |
Approved |
| Government High School |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents studying in Government rural schools |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable
|
| Intervention |
Resilience enhancement program |
SI. No. Topics Duration
1 Introduction, setting group guidelines, and listening skills 60 minutes
2 Understanding challenges and adversities 60 minutes
3 Discussing strengths and setting goals (a sense of purpose) 60 minutes
4 Identifying and awareness of emotions and discussing coping strategies 60 minutes
5 Managing strong emotions benefit
finding and assertive communication 90 minutes
6 Restorative practices for conflict resolution and problem solving and identifying and opposing violence 120 minutes
7 Self-esteem and problem-solving in the context of adversity 90 minutes
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents studying in government rural schools at Bnagarpet rural block |
|
| ExclusionCriteria |
| Details |
1. Adolescents who are not interested in participating in the study will be excluded.
2. Adolescent parents who are not giving consent for the study will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resilience |
Post-assessment and follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Coping and self-esteem |
3 months |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
16/09/2023 |
| 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="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The title of the study is resilience enhancement program for school going adolescents The aim of the study is to test the effectiveness of the resilience enhancement program for adolescents from government rural schools
The method of the study will adopt an experimental design. adolescents from government schools at Bangarpet block, Kolar district, Karnataka will be considered. the selected schools will be randomly allotted to the experimental and waitlisted groups. The sample size was estimated using G power software. the sample size was 76 each for the experimental and waitlisted group. the adolescents will be recruited based on the inclusion and exclusion criteria of the study.
The contents for the resilience enhancement program will be selected from the existing programs. the literature on resilience programs for adolescents will be thoroughly searched. the adolescents, teachers, school counsellors, and mental health professionals who have working experience with adolescents will be consulted in separate groups to validate and improvise the resilience enhancement program based on their views.
After
seeking their assent and parental consent, the adolescents will be recruited
from the selected schools. Following this, baseline data will be collected,
(intervention will be provided to the experimental group), and
post-intervention data will be collected from adolescents (from both
intervention and waitlisted groups). After three months of the intervention, a
follow-up assessment will be carried out then a booster session will be given
to the intervention group. The waitlisted group will be receiving the
intervention at a later point. The following tools will be used for
assessments: Connor Davidsons Resilience Scale
(CD-RISC) (Davidson, 2007), Rosenberg Self Esteem Scale (Rosenberg, 1965),
Adolescent Resilience Measurement Scale (ARMS) (Prabhu and Shekhar, 2018) and Brief Coping
Orientations to Problems Experienced (Brief COPE) scale (Carver, 1997).
The analysis will be done for the effectiveness testing of the
resilience enhancement program. Repeated measures ANOVA will be used to test
the effectiveness of the resilience enhancement program if the data is normally
distributed. If not, a nonparametric test of Friedman test will be used. |