| CTRI Number |
CTRI/2025/11/097186 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Influence Of Parenting Styles On Behavioural And Socio-Emotional Development Of Term And Preterm Preschool Children Born During The COVID-19 Pandemic |
|
Scientific Title of Study
|
Comparing The Influence Of Parenting Styles On Behavioural And Socio-Emotional Problems In Term And Preterm Pre-schoolers Born During The COVID-19 Pandemic: 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
Advanced Physiotherapy centre-Room 39, Sagar floor, KLE Dr.
Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| 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
Advanced Physiotherapy centre-Room 39, Sagar floor, KLE Dr.
Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayushi Singh |
| Designation |
Intern |
| 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
Advanced Physiotherapy centre-Room 39, Sagar floor, KLE Dr.
Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8789203826 |
| Fax |
|
| Email |
711ayushi@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute Of Physiotherapy, Belagavi, Karnataka, India. PIN code- 590010 |
|
|
Primary Sponsor
|
| Name |
Ayushi Singh |
| Address |
Advanced Physiotherapy centre-Room 39, Sagar floor, KLE Dr.
Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Type of Sponsor |
Other [Self] |
|
|
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 39, Sagar floor, KLE Dr.
Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA |
9845861236
drdeepa_metgud@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee, KAHER Institute Of Physiotherapy |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children between the ages of 3-5 years born during 2020-2022.
Children attending preschools in Belagavi city.
Parents of the child should be willing to participate in the study.
Both Pre-term and Term born children will be included irrespective of their gender.
|
|
| ExclusionCriteria |
| Details |
Children with developmental disorders.
Children whose parents are not willing to participate.
Children with sensory impairment (uncorrected hearing or vision loss)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Child Behaviour Checklist [CBCL (For 1.5-5 Years)]
|
T0 at the time of pre assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Parenting Style And Dimensions Questionnaire (PSDQ) |
T0 at the time of pre assessment |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
20/11/2025 |
| 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="6"
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 compare the influence of parenting styles on behavioral and socio-emotional problems in term and preterm preschoolers born during the COVID-19 pandemic in Belagavi City, Karnataka. It addresses a research gap on the prevalence of these problems post-pandemic, focusing on the role of parental involvement which was limited in previous studies due to restrictions. Using standardized assessments, the study evaluates internalizing, externalizing, and total behavioral problems in children aged 1.5 to 5 years. The findings are expected to inform targeted interventions for supporting child development and parenting strategies during challenging times.
|