| CTRI Number |
CTRI/2024/12/077862 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How the COVID-19 Pandemic Affected Preschoolers: Social, Emotional, and Behavioral Challenges and the Role of Parenting |
|
Scientific Title of Study
|
Prevalence of Socio-emotional and Behaviour problems in Preschoolers born during COVID-19 pandemic and its co-relation with Parenting Style: An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Metgud |
| Designation |
Physiotherapist |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy centre- Room 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brijesh M |
| Designation |
Physiotherapist |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy centre-Room 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8123276981 |
| Fax |
|
| Email |
u25brijeshyum@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brijesh M |
| Designation |
Physiotherapist |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy centre-Room 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8123276981 |
| Fax |
|
| Email |
u25brijeshyum@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi-590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepa Metgud |
KAHER institute of physiotherapy |
Advanced physiotherapy centre, Room No. 39, Paeditric Physiotherapy Department, KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
9845861236
drdeepa_metgud@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Institute of Physiotherpay |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy preschoolers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
- Children attending preschools in Belagavi city
- Parent/Guardian/LAR(Legally authorized representative) of the child should be willing to participate in the study |
|
| ExclusionCriteria |
| Details |
-Children with developmental disorder
- Children with unstable mental condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Child Behavioural Checklist(1.5-5) |
T0 at the time of pre assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parenting Style & Dimension Questionnaire |
T0 at the time of pre assessment |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
20/12/2024 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This study aims to assess the prevalence of behavioral and socio-emotional problems in preschoolers (ages 3-5) born during the COVID-19 pandemic in Belagavi city and examine the correlation with parenting styles. The research addresses a gap in existing studies, as most prior research focuses on children born during the pandemic between 2021-2022, with no studies looking at post-pandemic effects. The study will be observational in nature, with a sample size of 125 children from preschools in Belagavi, Karnataka, India. Data will be collected using the Child Behavioural Check List (1½ to 5 years) and the Parent Style and Dimension Questionnaire. The sampling technique will be cluster sampling followed by simple random sampling. The study will use probability sampling to ensure representative results. |