| CTRI Number |
CTRI/2023/01/049271 [Registered on: 30/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Stress, tension among children aged between ten and nineteen years residing in an urban area of Delhi |
|
Scientific Title of Study
|
Anxiety disorders among adolescents in an urban area of Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
FEBIDA BEEGAM P K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
JUNIOR RESIDENT, DEPARTMENT OF COMMUNITY MEDICINE,
2, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002
Central
DELHI
110002
India |
| Phone |
9496241267 |
| Fax |
|
| Email |
febibeegum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJESH KUMAR |
| Designation |
DIRECTOR PROFFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
ROOM NO 338 ,DIRECTOR PROFFESSOR, DEPARTMENT OF COMMUNITY MEDICINE,MAULANA AZAD MEDICAL COLLEGE, NEW DELHI-110002
Central
DELHI
110002
India |
| Phone |
9811656127 |
| Fax |
|
| Email |
prtickle07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
FEBIDA BEEGAM P K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
JUNIOR RESIDENT, DEPARTMENT OF COMMUNITY MEDICINE,
2, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002
Central
DELHI
110002
India |
| Phone |
9496241267 |
| Fax |
|
| Email |
febibeegum@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT OF COMMUNITY MEDICINE, MAULANA AZAD MEDICAL COLLEGE, NEWDELHI |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
2, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002 |
| 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 |
| Dr Febida Beegam |
URBAN HEALTH CENTRE GOKALPURI |
FIRST FLOOR, URBAN HEALTH CENTRE GOKALPURI
North East
DELHI |
9496241267
febibeegum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ADOLESCENTS(10-19 YEARS) RESIDING IN GOKALPURI AREA |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescents who are residing in the study area for more than 6 months. |
|
| ExclusionCriteria |
| Details |
Adolescents with
1.Severe acute illness
2.Chronic medical illness
3.Bedridden
4.Known case of other mental disorders
5.Diagnosed intellectual disability
• Subjects with hearing impairment/ blind. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of anxiety disorders among adolescents in an urban area of Delhi. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association of selected factors with anxiety disorders in the study population. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
02/02/2023 |
| 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="1"
Months="0"
Days="0" |
|
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
|
As adolescents are the future younger generation, their mental health is important. The combination of ignored psychosocial problems and the lack of mental health services in our country is amplifying the risk of precipitating academic underachievement and rising delinquent behaviour in adolescents. This makes for an early need for interventions and policies at the Institutional level to address adolescent anxiety and to create a mentally healthy future generation. This study tries to find the prevalence of anxiety disorders among adolescents in an urban area of Delhi and its associated risk factors , so an ealry intervention can be sought to prevent younger generation suffering from mental illnes. |