| CTRI Number |
CTRI/2024/04/065008 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Educating parents to identify early childhood developmental disorders |
|
Scientific Title of Study
|
Effect of Targeted Parental Education Intervention to Identify Early Childhood Developmental Disorder – Multisite Interventional 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 |
Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
PT14, SRM College of Physiotherapy, SRM Instituute of Science and Technology, Kattankulathur, Chengalpattu.
Chennai
TAMIL NADU
603203
India |
| Phone |
9841298555 |
| Fax |
|
| Email |
karulvela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
PT14, SRM College of Physiotherapy, SRM Institute of Science and technology, Kattankulathur, Chengalpattu.
Chennai
TAMIL NADU
603203
India |
| Phone |
9841298555 |
| Fax |
|
| Email |
karulvela@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
PT14, SRM College of Physiotherapy, SRM Institute of Science and technology, Kattankulathur, Chengalpattu.
Chennai
TAMIL NADU
603203
India |
| Phone |
9841298555 |
| Fax |
|
| Email |
karulvela@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT32, SRM College of Physiotherapy, SRM Institute of Science and technology, Kattankulathur, Chengalpattu. |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
2nd Main Road, near Ambattur, Karmari Amman Nagar, TNHB Colony, Bhavani Nagar, Ayappakkam, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vadivelan K |
SRM Medical College Hospital and Research Centre |
Department of Physiotherapy, SRM Medical College Hospital and research Centre,Kattankulathur
Chennai
TAMIL NADU |
9841298555
vadivelk@srmist.edu.in |
| Dr Subramanian Sethuraman |
St.Isabel’s Hospital |
Department of Physiotherapy, St. Isabels Hospital, ALwarpet
Chennai
TAMIL NADU |
9600124123
drsubbu69997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Antenatal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimethod parental educational intervention |
Education to identify early childhood developmental disorders through application, videos, pamphlets and TOT materials. The education materials and the intervention tool is under desk review |
| Comparator Agent |
Routine care with BCC materials |
Routine antenatal visits with printed materials about the early neurodevelopmental signs to identify early childhood developmental disorders |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women (from second trimester)
Antenatal women expected for preterm delivery |
|
| ExclusionCriteria |
| Details |
Difficulty in comprehension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome measure: A tool will be developed for identification of early childhood developmental disorder which will be administered by mothers
Identification of true positive early childhood developmental disorders by mothers |
Assessment will be done at 3rd, 6th, 9th and 12th month of childbirth.
Identification of true positive early childhood developmental disorders by mothers |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| level of improvement of knowledge in early childhood development disorders among the parents |
Before and after education |
|
|
Target Sample Size
|
Total Sample Size="1040"
Sample Size from India="1040"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 will be carried out among Antenatal mothers in 2nd Trimester of pregnancy and Mothers of preterm babies. Study will be carried out in three phases: Preparatory phase, implementation phase and evaluation phase. A tool will will meticulously codesigned with stakeholders to identify the early childhood developmental disorders and will be validated. A curriculum based multimethod teaching will be developed for antenatal women. curriculum will focus on educating mother on identification of early childhood disorder. Knowledge level of mothers on early childhood neurodevelopment disorders will be assessed with a brief questionnaire before and after maternal education. Effect of the educational program will be assessed with true positive cases of early childhood neurodevelopmental disorders identified by the mother. |