| CTRI Number |
CTRI/2024/11/076310 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Emotional and Behavioral Profiles of Children with Intellectual Disability |
|
Scientific Title of Study
|
Assessment of emotional and behavioral profile of children with Intellectual
Disability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashima Mehta |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics, Kasturba Hospital - Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8057205322 |
| Fax |
|
| Email |
ashima.mehta@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashima Mehta |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics, Kasturba Hospital - Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8057205322 |
| Fax |
|
| Email |
ashima.mehta@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ashima Mehta |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics, Kasturba Hospital - Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8057205322 |
| Fax |
|
| Email |
ashima.mehta@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Kasturba Hospital , Manipal, Udupi, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Ashima Mehta |
Kasturba Hospital |
Unit 1, Department of Paediatrics, Kasturba Medical College
Udupi
KARNATAKA |
8057205322
ashima.mehta@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70-F79||Intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
VSMS Score of 70 or below |
|
| ExclusionCriteria |
| Details |
VSMS Score 70-84
Children not accompanied by primary caregiver |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Behaviour profile will be determined based on SDQ into Normal, Borderline
and Abnormal, which will be then compared with VSMS subgroups. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| measurement of impact of behaviour difficulty on child’s daily functioning. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/11/2024 |
| 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="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
|
Globally the prevalence of emotional and behavioural problems are increase.It is already known that children with developmental problems may have up to 4 times the likelihood of having a concurrent mental health diagnosis compared with children who are typically developing. These problems not only impact on the daily functioning of children and put a strain on family but also hinder their learning and further development. Early identification and management of behavioural problems will help improve the quality of life and outcome. With this study we aim to identify emotional and behavioural problems which coexist in children with intellectual disability. We propose to conduct a prospective observational cross sectional study involving 30 children with Intellectual Disability aged between 2 years to 15 years presenting to Department of Paediatrics unit 1, Kasturba Hospital, Manipal. Institutional ethics committee approval has been obtained prior to the commencement of the study. The study will be registered under CTRI. A written informed consent will be obtained from care givers of each child prior to the recruitment into the study, since children with intellectual disability are being enrolled assent form will not be signed by them. A detailed history of presenting illness including developmental history will be recorded. Developmental examination and VSMS of each child will be done by the investigator. SDQ parent questionnaire will be filled by the parents. Impact questionnaire will be administered by the examiner. Scoring of SDQ questionnaires will be done by the examiners and results will be noted. All the data will be compiled and subjected to statistical analysis using mean, paired t-test, and simple linear regression, and compilation of the result will be done. |