| CTRI Number |
CTRI/2024/12/077667 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Caregiver training for parents of children with autism. |
|
Scientific Title of Study
|
Effectiveness of nurse delivered WHO Caregiver Skill Training Program compared to Treatment as Usual in Autism Spectrum Disorder children: 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 |
Suravi Patra |
| Designation |
Professor of Psychiatry |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar, Odisha, India |
| Address |
Room # 417, Academic Block, Department of Psychiatry,
All India Institute of Medical Sciences, Bhubaneswar,
Khordha
ORISSA
751019
India |
| Phone |
09438884222 |
| Fax |
|
| Email |
patrasuravi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suravi Patra |
| Designation |
Professor of Psychiatry |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar, Odisha, India |
| Address |
Room # 417, Academic Block, Department of Psychiatry,
All India Institute of Medical Sciences, Bhubaneswar,
ORISSA
751019
India |
| Phone |
09438884222 |
| Fax |
|
| Email |
patrasuravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suravi Patra |
| Designation |
Professor of Psychiatry |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar, Odisha, India |
| Address |
Room # 417, Academic Block, Department of Psychiatry,
All India Institute of Medical Sciences, Bhubaneswar,
ORISSA
751019
India |
| Phone |
09438884222 |
| Fax |
|
| Email |
patrasuravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research
Department of Health Research
Ministry of Health and family Welfare
Government of India
Ansari Nagar
New Delhi
Pin 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Suravi Patra |
All India Institute of Medical Sciences Bhubaneswar |
Room no 124
Psychiatry OPD
All India Institute of Medical Sciences Bhubaneswar
Odisha
Pin 751019
Khordha
ORISSA |
9438884222
patrasuravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar Institute Ethic Committee |
Submittted/Under Review |
|
|
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 |
AIIMS Pediatric Neurology Autism Parent training manual |
Nine weekly sessions including three home visits of two hours sessions on psychoeducation as per AIIMS Pediatric Neurology Autism Parent Training manual. |
| Intervention |
WHO Caregiver Skill training program |
Training of caregivers of children with autism by trained nurses.
behavioral training intervention shall be delivered weekly for two hours for nine weeks, out of which three sessions shall be home delivered. Total duration: 24 hours |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Meeting the DSM 5 diagnostic criteria for Autism Spectrum Disorder as per
1. AIIMS modified INCLEN diagnostic tool for Autism.
2. Indian Scale for Assessment of Autism. |
|
| ExclusionCriteria |
| Details |
i) Psychosis
ii) Unstable medical conditions
iii) Children not staying with at-least one parent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether treatment with WHO-CSTP as compared to TAU improved total ASD symptoms in children at risk/diagnosed with ASD. |
One month
two months
three months
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine whether treatment with WHO-CSTP as compared to TAU:
Improves adaptive functioning of children.
Improves overall functioning of children.
Improves caregiver empowerment
Reduces caregiver stress
|
One month
two months
three months
six months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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 3 |
|
Date of First Enrollment (India)
|
04/06/2025 |
| 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="3"
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
|
Autism Spectrum Disorders (ASD) have a prevalence of 1-1.5% in 2-6 years-old children. Untreated ASD causes a considerable burden. The limited availability of diagnostic and therapeutic services impacts the long-term outcome of children with ASD. Evidence-based caregiver-delivered interventions are known to improve both child and parent outcomes. Novelty: Implementation research on the World Health Organisation Caregiver Skill Training Program (WHO-CSTP) to caregivers of children diagnosed with ASD in routine clinical services. Objectives: Primary objective: To evaluate the effectiveness of WHOCSTP compared to Treatment as Usual for ASD symptoms. Secondary Objective: To evaluate the effectiveness of WHO-CSTP compared to Treatment as Usual on adaptive functioning, global functioning, caregiver empowerment, and caregiver stress in children diagnosed with ASD. Methods: Study site: Children 2-6 years of age diagnosed with ASD in Psychiatry OPD of a tertiary medical institute. WHO-CST group: Nine weekly group sessions of WHO CSTP for caregivers by trained nurses and three weekly at-home sessions. Treatment as Usual: Twelve sessions of Parent Education in groups using the Parent Autism Information booklet (Child Neurology Unit, AlIMS New Delhi). Study instruments. 1. AlIMS modified INDT tool for Autism Spectrum Disorder. 2. Modified CHecklist for Autism in Toddlers-R 3. Indian Scale for Assessment of Autism. 4. Developmental Disability- Childhood Global Assessment of Functioning scale. 5. Family Empowerment Scale 6. Parent Stress Scale Randomisation: Block randomisation using software to allocate 1:1 children to the WHO-CSTP or Treatment As Usual. Expected outcome: Effectiveness of WHO-CSTP in children with ASD. |