Sensory Intervention for Children With Autism

NCT06246487 | Completed

• 2 other identifiers: IRB202200163W81XWH-21-1-0594
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Neuroimaging

  Pre vs, post magnetic resonance imaging scans

  16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Occupational Therapy Intervention

Behavioral: Occupational Therapy Intervention

Control

NO INTERVENTION

No intervention

Interventions

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.

Intervention

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 16, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-08

Locations

US (1)