| CTRI Number |
CTRI/2024/12/078793 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Parent Mediated Intervention in children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Efficacy of Parent Mediated Intervention in children with Autism Spectrum Disorder as compared to standard Therapist based Intervention-a Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Suman |
| Designation |
Professor |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Child Development Clinic,
Institute of Child Health,
Sir Ganga Ram Hospital, New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9811244200 |
| Fax |
|
| Email |
praveensuman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praveen Suman |
| Designation |
Professor |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Child Development Clinic,
Institute of Child Health,
Sir Ganga Ram Hospital, New Delhi
DELHI
110060
India |
| Phone |
9811244200 |
| Fax |
|
| Email |
praveensuman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen Suman |
| Designation |
Professor |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Child Development Clinic,
Institute of Child Health,
Sir Ganga Ram Hospital, New Delhi
DELHI
110060
India |
| Phone |
9811244200 |
| Fax |
|
| Email |
praveensuman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital,Old Rajender Nagar,New Delhi,India,PINCODE 110060 |
|
|
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 Praveen Suman |
Sir Ganga Ram Hospital, New Delhi |
Child Development clinic,Department of Pediatrics, Institute of Child Health,Ward 6
New Delhi
DELHI |
9811244200
praveensuman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Parent Mediated Intervention |
Participants will receive 4 hrs/day of parent based intervention with adequate guidance of therapists |
| Intervention |
Standard therapist mediated Intervention |
Participants will be provided intervention by therapist 4 days/week |
|
|
Inclusion Criteria
|
| Age From |
24.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
Children Diagnosed with Autism Spectrum Disorder based on DSM V criteria |
|
| ExclusionCriteria |
| Details |
Children with hearing abnormality in BERA scan structural/progressive brain disorders
epileptic encephalopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of VQURA, a Parent mediated intervention as compared to standard therapist based intervention in children with Autism Spectrum Disorder |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the improvement in social quotient between two interventional groups |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/01/2025 |
| 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="1"
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
|
"Efficacy of Parent mediated intervention in children with autism spectrum disorder as compared to Standard Therapist based intervention"is a open label randomized controlled trial which will be conducted in childern aged 24 months to 36 months who are diagnosed with autism spectrum disorder and fulfill the DSM V criteria.It is a single center trial and will be conducted over period of one year in CDC,Sir Ganga Ram Hospital.Parents/Guardians of participants will be provided with complete information and informed consent will be taken at the time of enrollment. |