Sensory Intervention for Children With Autism

NCT ID: NCT06246487

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2025-06-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Occupational Therapy Intervention

Group Type: EXPERIMENTAL

Occupational Therapy Intervention

Intervention Type: 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.

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Occupational Therapy Intervention

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. The families of children will have access to transportation to attend intervention sessions 2 times per week for 16-weeks.

2. Children who qualify will be verbal, and will speak and understand English. The native language of caregivers can include Spanish.

3. 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

1. Female children

2. Auditory hyperresponsivity as assessed during screening procedures.

3. 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.

4. History of individual occupational therapy services in a clinical setting that includes sensory equipment.

5. Non-removable metal in the head or body (e.g. dental fillings & braces, metal pins, screws or plates).

6. Children unable to complete neurocognitive or sensorimotor testing.

7. Children unsuccessful in 3 mock scanning sessions during baseline testing.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

W81XWH-21-1-0594

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB202200163

Identifier Type: -

Identifier Source: org_study_id