Child, OnlyNCT07428876
The Effects of SITS in Children With Autism.
A study testing sensory integrated therapy exercises in people with Child, Only, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Child, Only
- What is being tested?
- sensory integrated therapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5 to 11
- highly functioning autistic children
- Either gender will be included
- children reported with sensory processing difficulties ,language and behaviour issues.
Who cannot join
- Any other neurological condition
- Children with physical disabilities
- sedative and hypnotic drug user
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Saeeda Maryum
Lahore, Punjab Province, 54000
Muhammad Asif Javed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effect of Sensory Integrated Therapy Exercises on Repetitive Behaviour, Communication, Social Interaction and Motor Skills in the Children With Autism Spectrum Disorder
The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT) . Outcome to be measure and analyze will be repetitive behavior, communication, social interaction and motor skills. Tools used for data collection are REPETITIVE BEHAVIOUR QUESTIONNAIRE (RBQ-2). Gallium autism rating scale (GARS) second edition. Data will be analyzed through the SPSS version 23:00
Read the detailed description
The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT).
Group A: Experimental group , This intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins.
Group B: Control Group, no intervention is applied.
- Conditions
- Child, Only
- Being tested
- sensory integrated therapy exercises
- Keywords
- Autism spectrum disorder (ASD), Sensory Integrated Therapy (SIT).
- 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 integrated therapy exercisesOther
This intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | experrimental group. This intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins. Receives: Other: sensory integrated therapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
REPETITIVE BEHAVIOUR QUESTIONNAIRE
The Repetitive Behaviour Questionnaire is a questionnaire designed to measure repetitive behaviour .It has two versions.it has total value 0-20
Measured: baseline, 1st week and 4th week
THE GILLIAM AUTISM RATING SCALE ,second edition
The Gallium autism ratind scale is a Autism screening tool developed by Dr. James E. Gilliam to serve as a practical piece of early childhood developmental screenings when teachers, parents and other people who observe children are worried that the child might have Autism.it has 3 main parts 0-42 value.
Measured: baseline, 1st week and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start22 Oct 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion23 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5\_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT) . Outcome to be measure and analyze will be repetitive behavior, communication, social interaction and motor skills. Tools used for data collection are REPETITIVE BEHAVIOUR QUESTIONNAIRE (RBQ-2). Gallium autism rating scale (GARS) second edition. Data will be analyzed through the SPSS version 23:00.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saeeda Maryum, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428876
- Sponsor's protocol ID
- REC/RCR&AHS/SAEEDAMARYUM
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patterson SY, Smith V, Jelen M. Behavioural intervention practices for stereotypic and repetitive behaviour in individuals with autism spectrum disorder: a systematic review. Dev Med Child Neurol. 2010 Apr;52(4):318-27. doi: 10.1111/j.1469-8749.2009.03597.x.
PubMed 20412248
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory Integrated Therapy Exercises on Repetitive Behaviour, Communication, Social Interaction and Motor Skills in the Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07428876
- Acronym / sponsor ID
- REC/RCR&AHS/SAEEDAMARYUM
- Conditions
- Child, Only
- Keywords
- Autism spectrum disorder (ASD), Sensory Integrated Therapy (SIT).
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 24 Feb 2026 (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.
The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT) . Outcome to be measure and analyze will be repetitive behavior, communication, social interaction and motor skills. Tools used for data collection are REPETITIVE BEHAVIOUR QUESTIONNAIRE (RBQ-2). Gallium autism rating scale (GARS) second edition. Data will be analyzed through the SPSS version 23:00
Detailed description
The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT).
Group A: Experimental group , This intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins.
Group B: Control Group, no intervention is applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT) . Outcome to be measure and analyze will be repetitive behavior, communication, social interaction and motor skills. Tools used for data collection are REPETITIVE BEHAVIOUR QUESTIONNAIRE (RBQ-2). Gallium autism rating scale (GARS) second edition. Data will be analyzed through the SPSS version 23:00.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: sensory integrated therapy exercisesexperrimental group. This intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 5 to 11
- highly functioning autistic children
- Either gender will be included
- children reported with sensory processing difficulties ,language and behaviour issues.
Key exclusion criteria (3 listed)
- Any other neurological condition
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 integrated therapy exercisesThis intervention will be applied during 12 sessions , 4 weeks and 3 session each week for 45 mins. | Other | experimental group |
Primary outcome
REPETITIVE BEHAVIOUR QUESTIONNAIRE
Time frame: baseline, 1st week and 4th week
The Repetitive Behaviour Questionnaire is a questionnaire designed to measure repetitive behaviour .It has two versions.it has total value 0-20
THE GILLIAM AUTISM RATING SCALE ,second edition
Time frame: baseline, 1st week and 4th week
The Gallium autism ratind scale is a Autism screening tool developed by Dr. James E. Gilliam to serve as a practical piece of early childhood developmental screenings when teachers, parents and other people who observe children are worried that the child might have Autism.it has 3 main parts 0-42 value.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 20412248Patterson SY, Smith V, Jelen M. Behavioural intervention practices for stereotypic and repetitive behaviour in individuals with autism spectrum disorder: a systematic review. Dev Med Child Neurol. 2010 Apr;52(4):318-27. doi: 10.1111/j.1469-8749.2009.03597.x.
- Individual participant dataSharing planned: No
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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.
Saeeda Maryum, MS-PT 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 integrated therapy exercises in people with Child, Only, 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 3 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, Phd (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REPETITIVE BEHAVIOUR QUESTIONNAIRE (time frame: baseline, 1st week and 4th week). The study lists 2 primary outcomes in all. 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 NCT07428876, which also lists 1 linked publication.
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 24 Feb 2026.