Autism Spectrum DisorderNCT06373770
Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum
A study testing Ayres sensory integration therapy and Behaviour Therapy in people with Autism Spectrum Disorder, run by Superior University at 1 site in Pakistan.
Trial summary
Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Ayres sensory integration therapy and Behaviour Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed cases of autism age range from 2 year to 8 years.
- All patients will be assed using sensory profile by Winnie Dunn.
- All the patients fulfilling the above-mentioned inclusion criteria will be assessed and evaluated by occupational therapist for sensory integration dysfunction.
Who cannot join
- All other patients not having diagnosed as autism spectrum criteria are excluded.
- All patients with sensory processing disorder assessed by using sensory profile.
Trial locations and contacts
1 site in 1 country.
About this study
Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum
Read the detailed description
"This study named effects of ayres sensory integration therapy versus conservative treatment in autism spectrum is a randomized clinical trail study.There is no evidence-based intervention protocol to treat sensory integration dysfunction in autism spectrum. This study may help finding best therapeutic treatment approach for sensory integration dysfunction results in repetitive behavior and impairments in functionality in autism spectrum.This study helps
- To evaluate best intervention plan for sensory integration dysfunction, Ayres sensory integration therapy versus conservative treatment in autism spectrum.
- To determine how many patients will be having what type of sensory integration dysfunction that come with autism spectrum leading to certain level of functional restrictions in Activity of Daily Livings (ADLs).
- Which type of sensory integration dysfunction having greater functional impairment and need to be focused more for intervention?
- To make better individualized rehabilitation treatment plan being an Occupational Therapist."
- Conditions
- Autism Spectrum Disorder
- Being tested
- Ayres sensory integration therapy, Behaviour 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.
Ayres sensory integration therapyDiagnostic test
- Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment. Sensory information may be visual, auditory, tactile, proprioceptive, and/or vestibular in nature. ASI uses individually tailored activities that utilize "just right" challenges to an individual's existing patterns of sensory processing and motor planning and encourage movement and organization of self in time and space. ASI incorporates specialized equipment and materials in purposeful and playful activities in order to improve adaptive behavior.
Behaviour TherapyDiagnostic test
The current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis. Medications have been most effective in treating the associated behavioral symptoms of autism, though studies have examined potential benefits in some of the core symptoms of autism with certain medications, especially the repetitive behaviors often seen with this diagnosis. Risperidone and aripiprazole are currently the only medications FDA approved for symptoms associated with autism spectrum disorders, targeting the irritability often seen with this diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Ayres sensory integration therapy | Experimental | A. Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment. Receives: Diagnostic Test: Ayres sensory integration therapy |
| Behaviour therapy | Other | The current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis. Receives: Diagnostic Test: Behaviour Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory profile by winnie dunn
sensory profile by winnie dunn willl be used to measure primary outcomes or initial assessment
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Oct 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373770
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/700
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum
- ClinicalTrials.gov ID
- NCT06373770
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/700
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Apr 2024 (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.
Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum
Detailed description
"This study named effects of ayres sensory integration therapy versus conservative treatment in autism spectrum is a randomized clinical trail study.There is no evidence-based intervention protocol to treat sensory integration dysfunction in autism spectrum. This study may help finding best therapeutic treatment approach for sensory integration dysfunction results in repetitive behavior and impairments in functionality in autism spectrum.This study helps
- To evaluate best intervention plan for sensory integration dysfunction, Ayres sensory integration therapy versus conservative treatment in autism spectrum.
- To determine how many patients will be having what type of sensory integration dysfunction that come with autism spectrum leading to certain level of functional restrictions in Activity of Daily Livings (ADLs).
- Which type of sensory integration dysfunction having greater functional impairment and need to be focused more for intervention?
- To make better individualized rehabilitation treatment plan being an Occupational Therapist."
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayres sensory integration therapy | Experimental | Diagnostic Test: Ayres sensory integration therapyA. Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment. |
| Behaviour therapy | Other | Diagnostic Test: Behaviour TherapyThe current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed cases of autism age range from 2 year to 8 years.
- All patients will be assed using sensory profile by Winnie Dunn.
- All the patients fulfilling the above-mentioned inclusion criteria will be assessed and evaluated by occupational therapist for sensory integration dysfunction.
Key exclusion criteria (2 listed)
- All other patients not having diagnosed as autism spectrum criteria are excluded.
- All patients with sensory processing disorder assessed by using sensory profile.
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 |
|---|---|---|
| Ayres sensory integration therapyA. Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment. Sensory information may be visual, auditory, tactile, proprioceptive, and/or vestibular in nature. ASI uses individually tailored activities that utilize "just right" challenges to an individual's existing patterns of sensory processing and motor planning and encourage movement and organization of self in time and space. ASI incorporates specialized equipment and materials in purposeful and playful activities in order to improve adaptive behavior. | Diagnostic test | Ayres sensory integration therapy |
| Behaviour TherapyThe current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis. Medications have been most effective in treating the associated behavioral symptoms of autism, though studies have examined potential benefits in some of the core symptoms of autism with certain medications, especially the repetitive behaviors often seen with this diagnosis. Risperidone and aripiprazole are currently the only medications FDA approved for symptoms associated with autism spectrum disorders, targeting the irritability often seen with this diagnosis. | Diagnostic test | Behaviour therapy |
Primary outcome
sensory profile by winnie dunn
Time frame: 12 Months
sensory profile by winnie dunn willl be used to measure primary outcomes or initial assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayres sensory integration therapy and Behaviour Therapy in people with Autism Spectrum Disorder, run by Superior 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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?
Results are not available in the source record.
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?
sensory profile by winnie dunn (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2024.