Sensory Intervention for Autism

Overseen By Stefanie Bodison

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Female, Auditory hyperresponsivity, Prematurity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how occupational therapy can help children with autism spectrum disorder (ASD) manage sensory differences and improve participation in everyday activities. Researchers will use MRI scans and behavioral assessments to examine how sensory interventions affect the brain and predict which treatments might work best for different children. Boys aged 6 to 8.5 with ASD who experience sensorimotor delays and can attend therapy sessions twice a week for 16 weeks may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance therapeutic approaches for children with ASD.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this sensory intervention is safe for children with autism?

Research has shown that Ayres Sensory Integration, a type of occupational therapy, is generally safe for children with autism spectrum disorder (ASD). A review of several studies confirmed that research supports this therapy. It has effectively helped children with ASD improve self-care, social skills, and achieve their goals, with no serious side effects reported.

Another study compared this therapy to other methods and found it beneficial for daily living skills, again without significant safety concerns. These findings suggest that the therapy is well-tolerated and safe for children with sensory processing issues related to autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this sensory intervention for autism because it focuses on occupational therapy, which aims to improve sensory processing skills in a highly personalized manner. Unlike many standard treatments that primarily rely on behavioral therapy to address social and communication challenges, this approach targets the sensory issues that often underlie these behaviors. By enhancing sensory integration, this method could lead to more direct improvements in daily functioning and quality of life for individuals with autism.

What evidence suggests that this occupational therapy intervention might be an effective treatment for autism?

Research has shown that occupational therapy using Ayres Sensory Integration can help children with autism spectrum disorder (ASD). In this trial, participants in the intervention arm will receive this therapy. Studies have found that this therapy leads to significant progress in personal goals. Children also sleep better and show fewer autism-related behaviors. Additionally, improvements occur in self-care, social skills, and achieving goals. These findings suggest that sensory interventions can positively impact daily life for children with ASD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children with Autism Spectrum Disorder (ASD) who often struggle with sensory processing. The study aims to understand how certain therapies can help them better engage in daily activities.

Inclusion Criteria

My son is between 6 and 8.5 years old and has been diagnosed with autism.

My family can travel twice a week for 4 months for the sessions.

Children must have sensorimotor delays as assessed by the study team using standardized, norm-referenced assessments (z-scores on 3 of 5 tests -1.0 or lower)

Exclusion Criteria

Auditory hyperresponsivity

Children unsuccessful in 3 mock scanning sessions during baseline testing

I am a girl.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive occupational therapy intervention or no intervention

16 weeks

Regular visits for MRI and behavioral assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Occupational Therapy Intervention

Trial Overview

The study tests the effects of Occupational Therapy interventions on children with ASD, using MRI and behavioral assessments to track changes in their brain related to sensory processing.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Occupational Therapy Intervention

Group II: Control Active Control 1 Intervention

No intervention

Occupational Therapy Intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Occupational Therapy for:

• Autism Spectrum Disorder (ASD)
• Sensory Processing Disorder (SPD)

Approved in European Union as Occupational Therapy for:

• Autism Spectrum Disorder (ASD)
• Sensory Processing Disorder (SPD)

Approved in Canada as Occupational Therapy for:

• Autism Spectrum Disorder (ASD)
• Sensory Processing Disorder (SPD)

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

A 10-week program of intensive occupational therapy using a sensory integrative approach led to improvements in sensory processing for one child with autism, as measured by standardized tests.

The child also showed enhanced participation in daily activities at home, school, and with family, based on parent-rated goal attainment scales, indicating the potential effectiveness of this therapy approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy using sensory integration to improve participation of a child with autism: a case report. Schaaf, RC., Hunt, J., Benevides, T.[2021]

Ayres Sensory Integration® (ASI) therapy shows strong evidence of improving individualized functioning and participation goals for children with autism, based on a systematic review of five studies including randomized controlled trials.

There is moderate evidence that ASI can lead to improvements in autistic behaviors and reduce the need for caregiver assistance in self-care activities, although evidence for enhancements in play, sensory-motor, and language skills is still emerging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Occupational Therapy Using Ayres Sensory Integration&#174;: A Systematic Review. Schaaf, RC., Dumont, RL., Arbesman, M., et al.[2022]

The manualized occupational therapy protocol using sensory integration principles is safe and feasible for children with autism, as demonstrated in a study involving 10 children aged 4-8 years.

Parents and therapists found the intervention acceptable, and therapists were able to follow the protocol effectively, suggesting readiness for further testing in a randomized control trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy and sensory integration for children with autism: a feasibility, safety, acceptability and fidelity study. Schaaf, RC., Benevides, TW., Kelly, D., et al.[2022]

The systematic review of 23 studies found moderate evidence supporting the effectiveness of Ayres Sensory Integration® (ASI) in improving daily life activities for individuals with autism spectrum disorder.

Results for sensory-based interventions (SBIs) were inconsistent, highlighting the need for more rigorous studies with larger sample sizes and standardized methods to better evaluate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Ayres Sensory Integration® and Sensory-Based Interventions for People With Autism Spectrum Disorder: A Systematic Review. Watling, R., Hauer, S.[2018]

The study examined the effects of Ayres Sensory Integration (ASI) intervention on play types in three autistic children aged 5 to 6 years, revealing that all participants showed changes in their play frequency after 24 ASI sessions, although the changes varied among individuals.

This research is significant as it is the first to investigate ASI's impact on play outcomes for autistic children, suggesting that ASI could potentially be an evidence-based intervention to enhance play, which is crucial for their development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ayres Sensory Integration® for Addressing Play in Autistic Children: A Multiple-Baseline Examination. Kuhaneck, HM., Watling, R., Glennon, TJ.[2023]

The study involved three boys aged 5-8 years with sensory-based motor disorders who underwent Ayres Sensory Integration (ASI) therapy three times a week for 10 weeks, showing significant improvements in motor coordination and functional performance.

Results indicated that all participants achieved their individualized goals and demonstrated large effect sizes in motor proficiency, suggesting that ASI is an effective intervention for children with sensory processing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Occupational Therapy Using a Sensory Integration Approach: A Multiple-Baseline Design Study. Andelin, L., Reynolds, S., Schoen, S.[2021]

A study involving 17 Brazilian children with autism spectrum disorder (ASD) found that occupational therapy using Ayres Sensory Integration significantly improved self-care and socialization skills compared to usual care.

The intervention group showed notable enhancements in parent-identified goal attainment, indicating that Ayres Sensory Integration is an effective evidence-based therapy for children with ASD, supporting its efficacy beyond the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy Using Ayres Sensory Integration®: A Randomized Controlled Trial in Brazil. Omairi, C., Mailloux, Z., Antoniuk, SA., et al.[2022]

A revised guidebook for parent education during Ayres Sensory Integration® (ASI) therapy received positive feedback from experts, practitioners, and parents, indicating it aligns well with ASI principles and is clinically useful.

The guidebook is now ready for further testing and implementation, contributing to best practices in parent education for children with autism undergoing ASI therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parent Guidebook for Occupational Therapy Using Ayres Sensory Integration®. Roan, C., Mailloux, Z., Carroll, A., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6590432/

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Effectiveness of Ayres Sensory Integration ® and Sensory ...

Findings of the Level I studies included significant improvement in individualized goals, improved sleep, decreased autism mannerisms, and ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05718362

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H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child with autism spectrum disorder. Official Title. Investigation of ...

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research.aota.org/ajot/article/76/4/7604205160/23325/Occupational-Therapy-Using-Ayres-Sensory

Occupational Therapy Using Ayres Sensory Integration

Occupational therapy using Ayres Sensory Integration was effective in enhancing self-care, socialization, and goal attainment for children with ASD in a ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11798754/

Examining the Effectiveness of Ayres Sensory Integration ...

A short-term, intensive ASI intervention improves motor performance, coordination, and daily activities function in children with DCD.

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onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/aur.70099

A Comparative Trial of Occupational Therapy Using Ayres ...

This study compared Occupational Therapy using Ayres Sensory Integration, Applied Behavior Analysis, and no treatment on daily living skills and ...

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trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07957-6

Exploring critical intervention features and trial processes in ...

We evaluated the clinical and cost-effectiveness of manualised sensory integration therapy (SIT) for autistic children with sensory processing difficulties.