- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06927583
Effect of Sensory Integration in Speech Therapy for Children With Autism
July 14, 2025 updated by: Riphah International University
Autism spectrum disorder (ASD) is considered one of the commonest developmental disabilities, characterized mainly by impairments in social performance and communicative skills, repetitive stereotypical behaviors, and restriction in interests and activities, with a combination of sensory, cognitive, behavioral, and communication features which persist throughout life.
Caminha & Lampreia specified that there is a significantly high prevalence of sensory processing dysfunctions in ASD.
Sensory processing means how the central and peripheral nervous systems deal with the incoming sensory input from different sensory organs; visual, auditory, smell, taste, tactile, proprioception, and vestibular information.
Sensory processing dysfunction is the neurological dysfunction affecting the adequate reception, modulation, integration, discrimination, or organization of sensory stimuli, and the behavioral responses to the sensory input.
Sensory integration therapy (SIT) is a frequent type of therapy that aims to improve a child's ability to perceive and integrate sensory input in order to explore more ordered and appropriate actions.
SIT improves motor skills, social relationships, attention, behavior control, language and pre-linguistic communicative abilities, reading comprehension, participation in play activities, and personal identification.
Therefore, the need for further explicit assessment of sensory integration intervention among ASD children has been increased to identify its gains in social and verbal interactions.
This study aimed to estimate the impact of sensory integration therapy on language development in autism spectrum disorder children.46
ASD children will enroll in this study, their ages ranged from 3-10 years, males and females, divided into two groups (group I received speech therapy sessions together with sensory integration therapy sessions, group II received speech therapy sessions only) went through two stages of evaluation before and after receiving their sessions with one year apart.
All children were subjected to Childhood Autism Rating Scale (CARS), sensory profile assessment by Short Sensory profile (SSP) and Assessment of Basic Language and Learning Skills- Revised (The ABLLS-R).Data will be taken from Clinics and Schools having children with autism
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54500
- Hayyati Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pre diagnosed autistic children
- Both male and female
- Age range:3 years to 10 years
- Moderately severe
Exclusion Criteria:
- Autism with any comorbid will be excluded ( hearing impaired, Any syndrome)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensory integration therapy
Experimental group was given sensory integration therapy .total
number of 5 sessions give t o each participant that comprised of 30 minutes.
|
sensory integration therapy include 2 categories that comprised of 9 strategies.
Other Names:
|
|
Active Comparator: Traditional Speech therapy
Control group was given traditional speech therapy .total
number of 5 sessions give t o each participant that comprised of 30 minutes.
|
Control group was given traditional speech therapy .total
number of 5 sessions give t o each participant that comprised of 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Basic Language and Learning Skills- Revised (ABLLS-R)
Time Frame: baseline and 6 weeks
|
The ABLLS-R scoring system evaluates a child's skills across 25 developmental areas.
Each task within a skill area is broken into steps, scored on a 0-2 scale: 0 for no skill, 1 for emerging or assisted performance, and 2 for independent mastery.
The scores for all steps in a task are totaled to give a task score, which contributes to the overall skill area score.
A visual tracking grid is used to record and color-code performance, helping identify strengths, areas for improvement, and track progress over time.
This scoring guides individualized goal setting and intervention planning.
|
baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hina Omer, Ms(SLP), Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barros VdM, Folha DRdSC, Pinheiro RC, Della Barba PCdSJCBdTO. Sensory processing and engagement: a systematic review. 2023;31:e3521.
- Randell E, Wright M, Milosevic S, Gillespie D, Brookes-Howell L, Busse-Morris M, Hastings R, Maboshe W, Williams-Thomas R, Mills L, Romeo R, Yaziji N, McKigney AM, Ahuja A, Warren G, Glarou E, Delport S, McNamara R. Sensory integration therapy for children with autism and sensory processing difficulties: the SenITA RCT. Health Technol Assess. 2022 Jun;26(29):1-140. doi: 10.3310/TQGE0020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2025
Primary Completion (Actual)
June 1, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
April 7, 2025
First Posted (Actual)
April 15, 2025
Study Record Updates
Last Update Posted (Actual)
July 15, 2025
Last Update Submitted That Met QC Criteria
July 14, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0659
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Adia Med of Winter Park LLCActive, not recruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Poznan University of Physical EducationNational Science Centre, PolandCompletedAutism Spectrum Disorder | ASD | Autism Spectrum Disorder High-Functioning | Autism SpectrumPoland
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
Blinklab LimitedRecruitingAutism Spectrum Disorder | Autism | Neurodevelopmental Conditions | Autism Spectrum Disorder (ASD)United States
-
National Cheng-Kung University HospitalCompletedAutism Spectrum Disorder (ASD) | Autism Spectrum Disorder High-FunctioningTaiwan
-
Healing Hope InternationalKurve Technology Inc.Enrolling by invitationNeurodevelopmental Disorders | Autism Spectrum Disorder | Autistic Disorder | Autism Spectrum Disorder (ASD) | Autistic Disorders Spectrum | Autism Spectrum Disorder High-Functioning | Autism Spectrum Disorder With Impaired Functional Language | Autistic Disorder of Childhood Onset With Full Syndrome and other conditionsUnited States
-
University of California, Los AngelesUniversity of WashingtonRecruitingAutism Spectrum Disorder (ASD)United States
Clinical Trials on sensory integration therapy
-
Ain Shams UniversityCompletedChildren | Autism Spectrum Disorder | TherapyEgypt
-
Hacettepe UniversityCompleted
-
Hacettepe UniversityRecruitingObstetric Brachial Plexus InjuryTurkey
-
Izmir Bakircay UniversityRecruiting
-
Necmettin Erbakan UniversityCompletedChewing Difficulties in Children | Feeding Behavior Challenges | Oral-motor Dysfunction | Impaired Chewing FunctionTurkey (Türkiye)
-
Hacettepe UniversityAnkara Medipol UniversityCompletedSocial Skills | Motor Activity | Emotional Regulation | Attention Deficit Disorder With Hyperactivity | Cognitive Deficit in Attention | Sensory Integration Disorder | Behavior HyperactiveTurkey
-
Biruni UniversityCompleted
-
Kirsehir Ahi Evran UniversitesiCompleted
-
Cairo UniversityNot yet recruiting
-
Albert Einstein College of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted