Sensory Intervention for Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Assessing Heterogeneity of Treatment Response in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246487
• Other study ID #: IRB202200163
• Secondary ID: W81XWH-21-1-0594
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: June 26, 2025

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: Stefanie Bodison
• Phone: 3109903729
• Email: stefaniebodison[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 26, 2025
• Est. primary completion date: April 26, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroimaging	Pre vs, post magnetic resonance imaging scans	16 weeks