Sensory Intervention for Children With Autism

University of Florida

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Occupational Therapy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06246487

IRB202200163

W81XWH-21-1-0594 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Male

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Intervention

Experimental group

Description:

Occupational Therapy Intervention

Treatment:

Behavioral: Occupational Therapy Intervention

Control

No Intervention group

Description:

No intervention