| CTRI Number |
CTRI/2025/05/086405 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Speech Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Speech and communication skills in Children with Autism Using Oral Placement Therapy |
|
Scientific Title of Study
|
Evaluating the Role of Oral Placement Therapy in Improving Sound Production and Oral Fixation Issues among Indian Children with Autism |
| Trial Acronym |
OPT-IN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramandeep Kaur |
| Designation |
Professor and In-Charge |
| Affiliation |
Father Muller Charitable Institution |
| Address |
Father Muller College,
Department of Speech and Hearing,
Kankanady,
Mangalore
Father Muller College,
Department of Speech and Hearing,
Kankanady,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9742229093 |
| Fax |
|
| Email |
ramandeepslp@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramandeep Kaur |
| Designation |
Professor and In-Charge |
| Affiliation |
Father Muller Charitable Institution |
| Address |
Father Muller College,
Department of Speech and Hearing,
Kankanady,
Mangalore
Father Muller College,
Department of Speech and Hearing,
Kankanady,
Mangalore
KARNATAKA
575002
India |
| Phone |
9742229093 |
| Fax |
|
| Email |
ramandeepslp@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramandeep Kaur |
| Designation |
Professor and In-Charge |
| Affiliation |
Father Muller Charitable Institution |
| Address |
Father Muller College,
Department of Speech and Hearing,
Kankanady,
Mangalore
Father Muller College,
Department of Speech and Hearing,
Kankanady,
Mangalore
KARNATAKA
575002
India |
| Phone |
9742229093 |
| Fax |
|
| Email |
ramandeepslp@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Centre |
|
|
Primary Sponsor
|
| Name |
Father Muller Research Centre |
| Address |
Father Muller Research Centre,
Father Muller Campus,
Father Muller Road,
Kankanady, Mangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Ramandeep Kaur |
Father Muller College |
Room No. 67,
Department of Speech and Hearing,
Mangalore,
Karnataka-575002
Dakshina Kannada
KARNATAKA |
09742229093
ramandeepslp@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Oral Placement Therapy |
Oral Placement Therapy (OPT) – A structured, multisensory, oral-motor intervention delivered 3 times per week (30 minutes/session) for 10 months. Administered by a certified speech-language pathologist using TalkTools-based methods and custom oral-motor tools. Focus areas include sensory regulation, jaw-lip-tongue coordination, articulation, and phonation. Home-based tasks are assigned weekly for parent-led reinforcement. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children within the Age range of 4 to 12 years.
2. Children diagnosed with Autism by Speech Pathologist or clinical psychologist or developmental pediatrician, based on Childhood Autism Rating Scale (CARS) assessment
3. Children with speech production deficits and presence of oral fixation behaviors |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to evaluate the effectiveness of Oral Placement Therapy (OPT) in improving sound production, oro-sensory regulation, and oral health among Indian children with Autism. It will provide evidence-based insights for structured, culturally relevant OPT protocols. The study may reduce long-term therapy costs and improve communication, social participation, and quality of life for children with ASD. |
1. Improvement in sound production as measured by speech sound repertoire assessments at baseline, 5 months, and 10 months.
2.Improvement in oro-sensory regulation as measured by Marshalla Oral Sensorimotor Test (MOST) at baseline, 5 months, and 10 months.
3.Improvement in oral health-related quality of life as reported by parent questionnaires at baseline, 5 months, and 10 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
02/06/2025 |
| 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="20"
Months="7"
Days="2" |
|
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
|
Autism Spectrum Disorder (ASD) often presents with challenges in sound production, oro-sensory regulation, and oral behaviors such as mouthing and chewing. These difficulties arise from poor oral-motor coordination and sensory processing differences, affecting speech, feeding, and quality of life. Traditional speech therapies mainly target language and auditory skills but often overlook the motor and sensory needs critical for children with autism. Oral Placement Therapy (OPT) is a tactile-proprioceptive, motor-based approach designed to improve speech clarity and oral regulation. While OPT has shown promise internationally, its effectiveness among Indian children with autism remains largely unexplored.
This study aims to evaluate the impact of OPT on improving sound production, reducing oro-sensory fixation behaviors, and enhancing oral health-related quality of life in Indian children with ASD. Findings will help establish evidence-based, culturally relevant intervention strategies to support better communication and functional outcomes among children with Autism |