| CTRI Number |
CTRI/2025/08/092169 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Program to support and enable parents of children with special needs in their role as parent |
|
Scientific Title of Study
|
Development and validation of an intervention module to support parenting occupations of parents of children with special needs |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keshavaram P |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy (3rd Floor), Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE)
Madhav Nagar, Near Tiger Circle
Manipal – 576104
Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8608368966 |
| Fax |
|
| Email |
p.keshavaram@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinita Acharya |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy (3rd Floor), Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE)
Madhav Nagar, Near Tiger Circle
Manipal – 576104
Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8608368966 |
| Fax |
|
| Email |
vinita.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Keshavaram P |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy (3rd Floor), Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE)
Madhav Nagar, Near Tiger Circle
Manipal – 576104
Karnataka, India
KARNATAKA
576104
India |
| Phone |
8608368966 |
| Fax |
|
| Email |
p.keshavaram@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
Mr. Keshavaram. P |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Veena Occupational Therapist |
Kalarava Centre for Child Development |
First floor, RSB windsor, behind Harsha mega store, near city bus stand, Udupi, Karnataka 576101
Udupi
KARNATAKA |
7510738158
kalaravacdc@gmail.com |
| Vidyashree Physiotherapist |
Manasa Rehabilitation and Training Centre |
Manasa Rehabilitation and Training Centre, Post Padubelle, via Shirva, Udupi, India- 574116
Udupi
KARNATAKA |
8970797201
manasapamboor@gmail.com |
| Deekshita Physiotherapist |
Samagra Shiksha Kendralaya |
Hajji Abdulla, Behind city bus stand, Udupi, Karnataka - 576101
Udupi
KARNATAKA |
9663514975
brcudupi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| KCDC-NOC |
No Objection Certificate |
| KMC and KH Institutional Ethics Committee |
Approved |
| Manasa Rehabilitation Centre |
No Objection Certificate |
| Samagra Shiksha Kendralaya |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention Module (for parents of children with special needs) |
The module might consist of 6-8 sessions, each lasting 45-60 minutes, allowing sufficient time for comprehensive engagement without overwhelming participants. Sessions will primarily be delivered face-to-face in small group settings, encouraging peer interaction and shared learning. To enhance the learning experience, a variety of teaching aids will be employed, including pamphlets, power point presentations, white boards, and charts. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Both Father and Mother, English or Kannada Speaking, Parents of children with ASD and ADHD aged between 5-10 years |
|
| ExclusionCriteria |
| Details |
Self-reported mental illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improved Parenting and Well-being – Enhanced parenting competence, self-care practices, and mental well-being among participants.
3. Increased Life Participation – Greater engagement in daily roles and improved parent-child interactions. |
Pre-test before the commencement of intervention module and Post-test after the completion of intervention module |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evidence for Practice – Contribution to evidence-based occupational therapy practices & feasibility for community implementation. |
Baseline & 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/09/2025 |
| 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="6"
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 aims to develop and validate an intervention module to support parenting occupations of parents of children with special needs (ASD and ADHD). It will be conducted in three phases: a qualitative study to understand parenting challenges, development and expert validation of the module, and a pilot test to assess feasibility and effectiveness. The study will use standardized tools (PSOC-R, HPAS, LPP) and appropriate statistical methods to measure outcomes. It is an interventional RCT planned from July 2027 to December 2027 |