| CTRI Number |
CTRI/2017/10/010119 [Registered on: 17/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of a stress management program among school going adolescent boys |
|
Scientific Title of Study
|
Effectiveness of group intervention in Ameliorating Stress among Adolescent Boys. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kallol Roy |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine, Kasturba Medical College, Manipal, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
9971967546 |
| Fax |
|
| Email |
kallol.karan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kallol Roy |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine, Kasturba Medical College, Manipal, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
9971967546 |
| Fax |
|
| Email |
kallol.karan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena G Kamath |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine, Kasturba Medical College, Manipal, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
veenak@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal University,
District -Udupi,
Manipal, Karnataka,
India
Pin code -576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Manipal University Manipal |
| Type of Sponsor |
Private 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 |
| Dr Veena G Kamath |
Kasturba Hospital, Manipal |
3rd Floor, Department of Community Medicine, Kasturba Medical College, Manipal, Manipal University
Udupi
KARNATAKA |
08202922324
kallol.roy@sas.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital, Manipal, Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal physical and mental health status of adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
Adolescent boys who were not intervened for till the intervention delivery for the control arm and the follow up in both arms were completed. |
| Intervention |
Intervention arm |
Adolescent boys who were intervened for seven days over a week for 45-50 minutes per day. Two follow ups post intervention at 1st and 3rd month.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Male |
| Details |
1. Adolescent boys of 12 to 15 years studying in English medium schools within the district. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean stress score |
Post intervention, Follow up after one and third month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean stress tolerance score |
Post intervention, Follow up after one and third month |
|
|
Target Sample Size
|
Total Sample Size="490"
Sample Size from India="490"
Final Enrollment numbers achieved (Total)= "507"
Final Enrollment numbers achieved (India)="507" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2013 |
| Date of Study Completion (India) |
31/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
To be sent for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study was aimed to estimate the prevalence of stress and stress tolerance among high school boys of Udupi district and to assess the effectiveness of a group intervention in ameliorating stress among them. To the best of our knowledge, this is the first study from an Indian population which focuses on the stress levels of adolescent boys with an intervention designed to address these stressors. A sample of 1202 adolescents aged 12-15 years were studied to estimate the prevalence of stress, stress symptoms and stress tolerance with the help of standardized Manipal Stress Questionnaire. The prevalence of stress among study participants was 55.9%. Of the total study participants, 65.3% of them were tolerant to stress i.e. had positive coping skills and 29.7% of them reported stress symptoms. Univariate analysis identified age, parental occupational and literacy status as significant determinants of adolescent stress and stress intolerance. Multivariate analysis identified socio demographic variables like age, religion, literacy status of mother and occupational status of father to be significant risk factors of stress among adolescent boys. A cluster randomized trial was undertaken to study the effectiveness of group intervention in ameliorating stress among adolescent males where 507 adolescent males were recruited and then randomized in to intervention and control arm. There was a significant improvement in the stress and stress tolerance scores observed in the intervention arm during the follow up at one and three months as compared to the control arm.
Clustering effect was taken in to account and adjusting the effects of clustering variables, a mixed model analysis was done. A negligible effect (4.2%) was reported |