Autism Spectrum DisorderNCT06927583
Effect of Sensory Integration in Speech Therapy for Children With Autism
A study testing sensory integration therapy and Traditional Speech therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- sensory integration therapy and Traditional Speech therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre diagnosed autistic children
- Both male and female
- Age range:3 years to 10 years
- Moderately severe
Who cannot join
- Autism with any comorbid will be excluded ( hearing impaired, Any syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Autism Spectrum Disorder
- Being tested
- sensory integration therapy, Traditional Speech therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory integration therapyOther
Also called Traditional speech therapy
sensory integration therapy include 2 categories that comprised of 9 strategies.
Traditional Speech therapyOther
Control group was given traditional speech therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sensory integration therapy | Experimental | Experimental group was given sensory integration therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes. Receives: Other: sensory integration therapy |
| Traditional Speech therapy | Active comparator | Control group was given traditional speech therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes. Receives: Other: Traditional Speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Basic Language and Learning Skills- Revised (ABLLS-R)
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.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start17 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hina Omer, Ms(SLP), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927583
- Sponsor's protocol ID
- REC/RCR & AHS/24/0659
- Status last verified
- Jul 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35766242
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory Integration in Speech Therapy for Children With Autism
- ClinicalTrials.gov ID
- NCT06927583
- Acronym / sponsor ID
- REC/RCR & AHS/24/0659
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory integration therapy | Experimental | Other: sensory integration therapyExperimental group was given sensory integration therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes. |
| Traditional Speech therapy | Active comparator | Other: Traditional Speech therapyControl group was given traditional speech therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pre diagnosed autistic children
- Both male and female
- Age range:3 years to 10 years
- Moderately severe
Key exclusion criteria (1 listed)
- Autism with any comorbid will be excluded ( hearing impaired, Any syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensory integration therapyAlso: Traditional speech therapysensory integration therapy include 2 categories that comprised of 9 strategies. | Other | Sensory integration therapy |
| Traditional Speech therapyControl group was given traditional speech therapy .total number of 5 sessions give t o each participant that comprised of 30 minutes. | Other | Traditional Speech therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- BackgroundBarros VdM, Folha DRdSC, Pinheiro RC, Della Barba PCdSJCBdTO. Sensory processing and engagement: a systematic review. 2023;31:e3521.
- Background: PubMed 35766242Randell 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.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hina Omer, Ms(SLP) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory integration therapy and Traditional Speech therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Basic Language and Learning Skills- Revised (ABLLS-R) (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06927583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.