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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Greater than 80% of children with autism spectrum disorder (ASD) experience sensory differences that make it difficult for them to fully participate in meaningful everyday activities. In this research study, we will use MRI and behavioral methods to assess how sensory interventions might change sensory brain structures, allowing us to better predict which sensory interventions might work best for whom.

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 data supports the effectiveness of the treatment Occupational Therapy Intervention, Occupational Therapy, Sensory Integration Therapy, Ayres Sensory Integration Therapy for autism?

Research shows that Ayres Sensory Integration Therapy can help children with autism improve their daily functioning and participation in activities. Studies found strong evidence for achieving personal goals and moderate evidence for reducing autistic behaviors and the need for caregiver assistance. ^{1 2 3 4 5}

Is Ayres Sensory Integration Therapy safe for humans?

The research does not specifically address safety concerns, but Ayres Sensory Integration Therapy is widely used and studied, suggesting it is generally considered safe for humans. ^{1 2 3 6 7}

How is the treatment 'Occupational Therapy Intervention' different from other treatments for autism?

Occupational Therapy Intervention, specifically Ayres Sensory Integration Therapy, is unique because it focuses on improving how individuals with autism process and integrate sensory information, which can enhance their daily life activities and participation. Unlike other treatments, it uses a structured approach to help children achieve personal goals related to functioning and participation, with evidence supporting its effectiveness in reducing caregiver assistance and improving play, sensory-motor, and language skills. ^{1 2 3 6 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Occupational Therapy Using Ayres Sensory Integration®: A Randomized Controlled Trial in Brazil. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Occupational Therapy Using Ayres Sensory Integration&#174;: A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Occupational therapy using sensory integration to improve participation of a child with autism: a case report. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Occupational therapy and sensory integration for children with autism: a feasibility, safety, acceptability and fidelity study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Ayres Sensory Integration® for Addressing Play in Autistic Children: A Multiple-Baseline Examination. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Parent Guidebook for Occupational Therapy Using Ayres Sensory Integration®. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Occupational Therapy Using a Sensory Integration Approach: A Multiple-Baseline Design Study. [2021]