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CTRI Number  CTRI/2024/05/066587 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Can caregivers be trained in an online format, to teach skills to their children with intellectual disabilities? 
Scientific Title of Study   Teleassisted caregiver mediated intervention for children with Disorders of Intellectual Development - A feasibility 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  Ananya Malhotra 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Psychiatry, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9811013609  
Fax    
Email  ananya.malhotra1705@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr PSVN Sharma 
Designation  Professor and Head of Unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Psychiatry, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922778  
Fax    
Email  psvn.sharma@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr PSVN Sharma 
Designation  Professor and Head of Unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Psychiatry, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922778  
Fax    
Email  psvn.sharma@manipal.edu  
 
Source of Monetary or Material Support  
Department of Psychiatry, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka, India- 576104 
 
Primary Sponsor  
Name  Department of Psychiatry 
Address  OPD no. 33, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka, 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananya Malhotra  Kasturba Hospital  OPD Number 33, Department of Psychiatry, Kasturba Hospital, Manipal, Madhav Nagar, Karnataka, 576104
Udupi
KARNATAKA 		 9811013609

ananya.malhotra1705@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F70-F79||Intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Teleassisted caregiver mediated intervention for children with Disorders of Intellectual Development  The intervention group will receive the manualized intervention of 6-session module for improving functional adaptive skills for children with Disorders of Intellectual Development imparted via telehealth mode delivered by the trainee. Session 1 and 6 will be in-person (same as treatment as usual) and the other four sessions will through an online video-conferencing platform delivered by the trainee. 
Comparator Agent  Treatment as usual  They will receive in-person treatment as usual at baseline and after 12 week comprising of medical management and psychoeducation of the caregiver. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1.Age of children- 2 to 9 years.
2.Treated under the Department of Psychiatry or Pediatrics, KMC Manipal.
3.Diagnosis of Disorder of Intellectual Development according to ICD 11.
4.Informed consent given by caregiver/ parent.
5.Availability of a computer, phone, tablet with high-speed internet to have online video-conferencing sessions.
 
 
ExclusionCriteria 
Details  1.Parents’ participation in any other programs involving parent training for building functional adaptive skills or behavior modification in their child.
2.Children undergoing specific behavioral training for functional adaptive skills in special schools
3.Children/caregiver having acute medical or psychiatric conditions that will interfere with their participation in the study.
4.Moderate to severe hearing loss or visual impairment.
5.Severe locomotor disability.
6.Refusal to consent for the study.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Completion of participation in the study with structured feedback from care-provider (trainee therapist) and caregiver independently (verified by Guide) about
a. Dropout rates in intervention versus control group.
b. Completeness in terms of sessions attended.
c. Fidelity to protocol (of therapist and parent).
d. Comfort of caregiver to utilize the intervention (practicality in terms of resources, time, and commitment).
e. Any difficulties the caregiver had during the intervention (qualitative feedback).
2. Change in a Family interview for stress and coping in mental retardation (FISC-MR) Score – Coping Subdomain. 		 Baseline and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
CHILD RELATED OUTCOMES
1. Attainment of functional skills at follow-up (Measured by VSMS and BASIC-MR).
2. Acceptability of intervention as reported in caregiver feedback.
TRAINEE FIDELITY AND ACCEPTABILITY
1. Independent rating of randomly picked up 10% of video-recorded sessions by the supervisor for fidelity measures.
2. Trainee’s perceived self-efficacy and acceptability by caregivers (measured by qualitative comments in caregiver feedback) 		 Baseline and 12 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   11/05/2024 
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 is a quasi-experimental Interventional study aiming to assess the feasibility of a caregiver-mediated intervention for children with Disorders of Intellectual Development (DID) delivered via telehealth. It involves two groups - an Intervention group and a Control group receiving treatment as usual (TAU). The study aims to recruit 70 caregivers of children aged 2 to 9 with DID from KMC Manipal. Caregivers will be randomly assigned to either group after providing informed consent, including consent for video-recording of online sessions. Baseline and final assessments will be conducted in-person (VSMS, BASIC-MR, FISC-MR), with telepsychiatry guidelines followed during online sessions. The intervention group will receive four online intervention sessions. The primary quantitative outcome measure will be the change in Family Interview for Stress and Coping in Mental Retardation (FISC-MR) Score - Coping Subdomain, while qualitative outcomes will assess participation completion, protocol fidelity, participant comfort, and difficulties faced. 
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