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CTRI Number  CTRI/2025/08/093887 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Developing and Testing a Parent-Led Program to Help Children with Autism in School Years 
Scientific Title of Study   Multimodal Parent-Mediated Intervention Module for School – Age Children with Autism Spectrum Disorder: A Development, Feasibility, and Effectiveness 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  Ankita Dhiman  
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 
Address  Department of Clinical Psychology, The Department of Clinical Psychology, M.V. Govindaswamy Centre (3rd Floor), National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road

Bangalore
KARNATAKA
560029
India 
Phone  06303156549  
Fax    
Email  ankitadhiman2912@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ankita Dhiman  
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 
Address  Department of Clinical Psychology, The Department of Clinical Psychology, M.V. Govindaswamy Centre (3rd Floor), National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road

Bangalore
KARNATAKA
560029
India 
Phone  06303156549  
Fax    
Email  ankitadhiman2912@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ankita Dhiman  
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 
Address  Department of Clinical Psychology, The Department of Clinical Psychology, M.V. Govindaswamy Centre (3rd Floor), National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road

Bangalore
KARNATAKA
560029
India 
Phone  06303156549  
Fax    
Email  ankitadhiman2912@gmail.com  
 
Source of Monetary or Material Support  
UGC Fellowship 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neurosciences 
Address  Hosur Road, Marigowda Road Lakkasandra, Wilson Garden), Bengaluru 560029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Miss Ankita Dhiman and Dr Anamika Sahu  NIMHANS   Hosur Road, Wilson Garden
Bangalore
KARNATAKA 		 9868996713

cpanamika159@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multimodal Parent Mediated Intervention for School-Age children   The trial involves development of Intervention. This will be completed after need assessment. A written therapy format will be developed. It will include details about the rationale of intervention, intervention targets and components, approaches, specific techniques, the number of sessions, duration of each session, frequency of session, and potential barriers to participation as well as mechanisms to address them. A combination of intervention techniques like - psychoeducation, familiarizing parents with use of PECS/ Videos for aiding communication, child-centred play, use of role play for increased socialization and participation, use of social-story, dyadic instruction and prompts for developing perspective taking, use of modelling, scaffolding, self-instruction activities for teaching metacognitive skills. Other additional techniques will be incorporated along the process of development. These modules will target deficits in social communication, cognitive development and some behaviour skill training. Intervention will be delivered in a hybrid manner including both in-person and online individual sessions, depending on the convenience of the participants. The intervention will consist of core modules, spanning approximately 12 -15 weeks - a 75 minute online/offline [AS3.1]session and one telephonic doubt clearing session every week (however, the participants will be requested to adhere to a minimum of four initial offline sessions). If online therapy sessions are deemed necessary, they will adhere to the Tele-Psychotherapy Guidelines, Version 1.0, issued by the Department of Clinical Psychology, NIMHANS. Content validation of the intervention will be done consulting at least six experts. Experts with 5 years of professional experience in the management of ASD and those with experience developing psychological intervention programs will be approached with the draft of the intervention manual.  
Comparator Agent  Not Applicable  Not Applicable  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  For Children,
1. Children aged 6 to 10 years, all genders.
2. Clinically diagnosed ASD of mild to moderate severity (INDT ASD and ISAA)
3. Social Intelligence quotient (IQ/SIQ) greater than 80, on VSMS or CPM)
4. Availability of at least one parent
5. Speaks and comprehend English and Hindi
6. Parent’s written consent and children’s assent
For Parents,
1. Education till 10th std.
2. Parents staying with their child for a minimum of three years.
 
 
ExclusionCriteria 
Details  Children having clinical/medical diagnosis and of comorbid psychiatric conditions apart from mild to moderate ADHD.

For Parents, parents with medical conditions that significantly impair their ability to participate in the study activities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Social Communication   4 time points. Pre Intervention, Mid Intervention, Post Intervention and 2 month follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Parent’s stress and coping style.
 		 Pre and Post Intervention 
Autism severity.   Three time points - Screening, Post and Follow up. 
Perspective taking   Pre Intervention, Mid Point, Post Intervention and Follow up 
Metacognition   Pre Intervention, Mid Point, Post Intervention and Follow up 
Adaptive Behaviour   Pre Intervention, Mid Intervention, Post Intervention and Follow up.  
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 2 
Date of First Enrollment (India)   01/10/2025 
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="0"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ankitadhiman2912@gmail.com].

  6. For how long will this data be available start date provided 01-07-2027 and end date provided 30-06-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study aims to develop a Parent-Mediated Intervention for school-aged children (6–10 years) with Autism Spectrum Disorder (ASD) and to evaluate its feasibility and effectiveness. The intervention is being developed and tested in two phases. Phase 1 focuses on the development of the intervention. In Step 1, existing resources are reviewed. In Step 2, interviews are conducted with 20 participants, including parents of children with ASD, mental health professionals, and special educators, to identify key needs and suitable techniques. Based on these insights, Step 3 involves designing the content and structure of the intervention. In Step 4, expert evaluation is carried out to establish face and content validity of the screening scale and assessment battery. Finally, in Step 5, the intervention is piloted with 3 children with ASD. Phase 2 assesses the feasibility and effect of the intervention by recruiting 25 children with ASD aged 6 to 10 years with an IQ above 80. Baseline assessments are conducted using standardized tools, followed by the introduction of a multimodal intervention. Mid-intervention and post-intervention assessments are conducted after two weeks, with a follow-up assessment at two months.  
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