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CTRI Number  CTRI/2026/02/104938 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A Training Program for Caregivers to Help Manage Behavioural Difficulties in Adolescents and Adults with Autism 
Scientific Title of Study   Development And Feasibility of Caregivers Skills Training For Managing Challenging Behaviours In Transitional Age Group Persons With Autism Spectrum Disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Kansal 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Psychiatric Rehabilitation Services, Department of Psychiatry, National Institute of Mental Health and Neuro Sciences

Bangalore
KARNATAKA
560029
India 
Phone  9582580812  
Fax    
Email  shwetadrc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Hareesh Angothu 
Designation  Additional Professor of Psychiatry 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Psychiatric Rehabilitation Services, Department of Psychiatry, National Institute of Mental Health and Neuro Sciences

Bangalore
KARNATAKA
560029
India 
Phone  7022244405  
Fax    
Email  hareesh.angothu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shweta Kansal 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Psychiatric Rehabilitation Services, Department of Psychiatry, National Institute of Mental Health and Neuro Sciences

Bangalore
KARNATAKA
560029
India 
Phone  9582580812  
Fax    
Email  shwetadrc@gmail.com  
 
Source of Monetary or Material Support  
Psychiatric Rehabilitation Services, Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bangalore, Karnataka, India, 560029 
 
Primary Sponsor  
Name  Psychiatric Rehabilitation Services Department of Psychiatry NIMHANS 
Address  National Institute of Mental Health and Neuro Sciences, Bangalore (NIMHANS), Karnataka, India, 560029 
Type of Sponsor  Government 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 Hareesh Angothu  NIMHANS  Room no. 2, ground floor, Psychiatric Rehabilitation Services (PRS), Department of Psychiatry, NIMHANS, Bangalore
Bangalore
KARNATAKA 		 7022244405

hareesh.angothu@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 
Healthy Human Volunteers  CAREGIVERS OF ADOLESCENTS AND ADULTS WITH AUTISM SPECTRUM DISORDER 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caregivers Skills Training (CST)   After receiving the consent, baseline assessment will be carried down for each caregiver before starting the training of the developed CST manual. Subsequently, the training of each module will start. The tentative training of approximately 10-12 hours will be given individually to each participant in English or Hindi. Each session would be of approximately 45-60 minutes, with a minimum gap of approximately 5-7 days between each training session. In order to gain insight into the knowledge and skills learnt by caregivers during the training period, each caregiver will be assessed after each module through open-ended questions and standardised tools. After the completion of the training, each caregiver will go through a post assessment.  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Caregivers of TAG (Transitional Age Group) persons with ASD (14 to 25 years of age) with or without psychiatric comorbidity, residing in Bangalore or are willing to visit NIMHANS during CST training, can read, write and understand English or Hindi, caregivers who have been living with TAG persons with ASD in the same house for at least 6 months and would be continuing to stay during the CST training and provide informed written consent. 
 
ExclusionCriteria 
Details  Caregivers who received any other structured CST in the preceding six months, caregivers who have professional background related to mental health sector (Psychiatric nurses, psychiatrists, clinical psychologists, and psychiatric social workers) and caregivers who require psychiatric hospitalisation for their own emotional health problems in the preceding six months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To develop a Caregiver Skills Training Program for managing challenging behaviours in transitional age group persons with ASD and to validate it by professionals and caregivers.

2. To assess the feasibility of CST by providing training to selected caregivers of transitional age group persons with ASD. 		 At baseline and after completion of the training of the whole manual, approximately 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the quality of life, self-efficacy, caregiver burden, & well-being in the caregivers supporting TAG persons with ASD.

2. To study the perceived usefulness of CST in caregivers who complete the CST using in depth qualitative interviews. 		 At baseline & after completion of the training of the whole manual, approximately 4 months 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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 4 
Date of First Enrollment (India)   01/10/2026 
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   This study aims to develop and test the feasibility of a culturally relevant Caregiver Skills Training (CST) module to help caregivers manage challenging behaviours in transitional age group (14-25 years) persons with Autism Spectrum Disorder (ASD). Using a multi-phasic mixed-methods design, Phase I will involve a scoping review of existing caregiver training programs and challenging behaviours in this population. Phase II will explore caregivers and professionals perspectives through qualitative interviews. Phase III will focus on developing and expert-validating an evidence-based CST manual. Phase IV will assess feasibility through a pilot caregiver training with pre-post evaluation. Secondary outcomes include examining caregiver quality of life, self-efficacy, burden, well-being and perceived usefulness of the CST. Quantitative data will be analysed using descriptive statistics in SPSS, while qualitative data will undergo inductive thematic analysis, supported by ATLAS.ti. 
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