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Completed

NCT Number: NCT06246487

Sensory Intervention for Children With Autism

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.

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Key information

Age range

6 year–9 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male children 6 years, 0 months to 8 years, 6 months of age with a diagnosis of autism spectrum disorder (ASD) will qualify for inclusion. Our inclusion age ensures all study participants will complete intervention/control conditions and be retested before they turn 9 years of age. Additional inclusion criteria include:

  • The families of children will have access to transportation to attend intervention sessions 2 times per week for 16-weeks.
  • Children who qualify will be verbal, and will speak and understand English. The native language of caregivers can include Spanish.
  • Children who qualify will have sensorimotor delays as assessed by the study team using the standardized, norm-referenced assessments described in this research proposal (z-scores on 3 of 5 tests -1.0 or lower).

Exclusion criteria

Children younger than 6 years of age or older than 8 years, 6 months of age will be excluded. Additional exclusion criteria include:

  • Female children
  • Auditory hyperresponsivity as assessed during screening procedures.
  • Medical co-morbidities such as extreme prematurity (less than 28 weeks), blindness, deafness, cerebral palsy, Down Syndrome, tuberous sclerosis, or head-injury with loss of consciousness.
  • History of individual occupational therapy services in a clinical setting that includes sensory equipment.
  • Non-removable metal in the head or body (e.g. dental fillings & braces, metal pins, screws or plates).
  • Children unable to complete neurocognitive or sensorimotor testing.
  • Children unsuccessful in 3 mock scanning sessions during baseline testing.

Treatment and study plan

Occupational therapy intervention

Behavioral

Children randomized to the intervention condition will receive a sensory enriched intervention 2x's per week, 60-minutes per session, for 16 weeks. The intervention will follow a codified protocol developed by Dr. Bodison that is theoretically grounded in neurodevelopmental research. The interveners will be occupational therapists who will be trained by Dr. Bodison to deliver the codified, intervention protocol to provide a personally customized set of therapeutically guided environmental interactions. Because, at its core, the intervention emphasizes playful interaction with a sensory enriched environment, the intervention room will be equipped with swings, scooter boards, climbing equipment, bolsters, and large carpeted barrels. Within this setting, using the codified manual of intervention developed by Dr. Bodison, the intervener will structure activities to provide tactile and proprioceptive input to address the child's individualized areas of need.

Primary outcomes

  1. Neuroimaging

    Time frame: 16 weeks

    Pre vs, post magnetic resonance imaging scans

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Assessing Heterogeneity of Treatment Response in Children With Autism Spectrum Disorder

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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