| CTRI Number |
CTRI/2025/09/095105 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational therapy ] |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the effectiveness of a 5-day training program for parents of children with neurodevelopmental disorders through pre and post-assessments. |
|
Scientific Title of Study
|
Effectiveness of a Brief Parent-Mediated Intervention Program on Parental Knowledge in Parents of Children with Neurodevelopmental Disorders: A One-Group Repeated Measures Design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Teresa Karunya Davis |
| Designation |
Post graduate student- Masters in Occupational Therapy-Advanced Mental Health |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no- 137 Nambikkai Nilayam, Child and Adolescent Psychiatry unit, Department of Psychiatry, Christian Medical College, Vellore-632004, Tamil Nadu
Vellore TAMIL NADU 632004 India |
| Phone |
9528960381 |
| Fax |
|
| Email |
teresakdavis16@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mr.Joseph Thomas Bedford |
| Designation |
Lecturer |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no- 137 Nambikkai Nilayam, Child and Adolescent Psychiatry unit, Department of Psychiatry, Christian Medical College, Vellore-632004, Tamil Nadu
Vellore TAMIL NADU 632004 India |
| Phone |
9894542067 |
| Fax |
|
| Email |
josephthomasraj@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ms Teresa Karunya Davis |
| Designation |
Post graduate student- Masters in Occupational Therapy-Advanced Mental Health |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no- 137 Nambikkai Nilayam, Child and Adolescent Psychiatry unit, Department of Psychiatry, Christian Medical College, Vellore-632004, Tamil Nadu
Vellore TAMIL NADU 632004 India |
| Phone |
9528960381 |
| Fax |
|
| Email |
teresakdavis16@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College, Vellore-632002
Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
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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 |
| Ms Teresa Karunya Davis |
Christian Medical College, Vellore |
Room no-137, Nambikkai Nilayam, Child and Adolescent Psychiatry unit, Department of Psychiatry, CMC, Vellore Vellore TAMIL NADU |
9528960381
teresakdavis16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, (2) ICD-10 Condition: F70||Mild intellectual disabilities, (3) ICD-10 Condition: F71||Moderate intellectual disabilities, (4) ICD-10 Condition: F848||Other pervasive developmental disorders, (5) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified, (6) ICD-10 Condition: F73||Profound intellectual disabilities, (7) ICD-10 Condition: F72||Severe intellectual disabilities, (8) ICD-10 Condition: F79||Unspecified intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Parental Knowledge Assessment |
Parent mediated Individual-Based Intervention Program for Parents of Children with Neurodevelopmental Disorders This is a structured 5-day hands-on training program for children aged 1-5 years to equip parents with knowledge and skills for managing and supporting their child’s development. The program includes Day-1: Psychoeducation,Day-2:Rewarding and Prompting,
Day-3:Behavior management, Day-4:Task Analysis and Day-5:Teaching Techniques and Home Program tailored to each childs needs. A Pre test is conducted at the beginning and a post test at the end of the program to evaluate Parental learning and progress using the Vellore Test of Parental Knowledge( V-TOP). |
| Comparator Agent |
Treatment As Usual(TAU) |
Routine sessions conducted in the division |
|
|
Inclusion Criteria
|
| Age From |
12.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
Parents of children diagnosed with NDD, including ASD, ADHD, learning disability, and Intellectual disability.
Parents enrolled in the five-day parent-mediated intervention program.
Parents literate in English, Tamil, or Hindi.
Parents enrolled for the first time in the five-day program. |
|
| ExclusionCriteria |
| Details |
Parents who previously attended the 12-week, 6-week, or five-day programs.
Parents of children with severe motor comorbidities (e.g., cerebral palsy). |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Parental knowledge of symptoms of Neurodevelopmental disorders and their interventions. |
T1- pre test
T2- post test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
31/08/2026 |
| 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="1" 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 - NO
|
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Brief Summary
|
Neurodevelopmental conditions are a group of disorders that affect brain function, leading to difficulties in learning, behavior, and social interaction. NDDs include autism spectrum disorder ASD, attention-deficit hyperactivity disorder ADHD, and intellectual disabilities, which often emerge in early childhood and can impact daily functioning across the lifespan. Parenting a child with a neurodevelopmental disorder NDD can be overwhelming, especially when parents lack the knowledge and resources to support their childs needs effectively. Many parents struggle to understand their childs condition, manage behaviours, and access appropriate services, which can create additional stress and prevent children from receiving the interventions they need. We would like to take the pre-intervention assessment at the beginning of the entire 5-day program, and the post-intervention assessment at the end of the entire 5-day program using the VTOP tool. The VTOP tool was found to have the content validity of 0.903 and the face validity of 0.795. In terms of reliability, the internal consistency measured using Cronbachs alpha method was 0.924. The content validity was established through expert review and opinion, and the face validity of the tool has been confirmed, indicating adequate validity. While pilot studies were conducted to assess the usability of the tool, its reliability has not yet been formally studied. A five-day parent-mediated training program has been designed to provide short-term intervention for parents who attend the sessions with their child everyday. This is primarily aimed at providing parents with knowledge and hands-on skill training on managing their child. Parent-mediated intervention is strongly recommended as a highly effective approach in paediatric occupational therapy, where 13 percent of reviewed interventions were directly aimed at parents, enabling them to deliver therapy within daily parenting routines at home. This approach leverages parents inherent knowledge of their childrens preferences and engagement styles, along with the substantial caregiving they provide, allowing for increased therapy intensity through home programs and self-management Novak and Honan 2019. Since the training is short, an observable change in the child is difficult to achieve hence, this study aims to evaluate the effectiveness of this program by assessing changes in parental knowledge before and after the training. Specifically, it also seeks to identify which areas show the most significant progress and determine aspects of the program that may need further refinement. Each childs parent will participate in the training and complete a questionnaire before and after the program to assess their learning. The questionnaire will be scored using a 3-point Likert scale. We have modified the tool by changing the response options to True, False, and Dont know. The scoring key is as follows False or Dont know 1, and True 2. Using this tool, we aim to calculate the change in scores for the pre and post-tests of the VTOP tool. The study adheres to relevant national and international ethical guidelines, including the Declaration of Helsinki, the Belmont Report, and the ICMR Guidelines. We ensure that no individual is denied access to the intervention, and the intervention is not altered for those who are not participants. Ethical considerations were central to our choice of a quasi-experimental design, as using a controlled experimental design would have required withholding therapy from a group of participants, which we deemed ethically inappropriate. Since randomization of sessions is not feasible as the sessions follow a protocol based on a hierarchy of information and a predetermined sequence, for the post-test we have instead modified the question order in the assessment tool, to reduce potential recall bias between the pre and post-tests. The areas that will be evaluated are knowledge on NDDs, behaviour management techniques, teaching techniques, task analysis, and sensory-based interventions. The results will be analysed and will lead us to find whether the program causes a significant increase in parental knowledge. If specific topics show minimal improvement, adjustments will be made to enhance future training sessions. |