Sensory intervention for children with autism
Assessing Heterogeneity of Treatment Response in Children With Autism Spectrum Disorder
This study tests if sensory therapy can help children with autism improve their daily activities by changing how their brains respond to sensory information.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 9 Years |
| Sex | Male |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06246487 on ClinicalTrials.gov |
What this trial studies
This research focuses on children with autism spectrum disorder (ASD) who experience sensory differences that hinder their daily activities. The study will utilize MRI and behavioral methods to evaluate how sensory interventions can alter sensory brain structures. By understanding these changes, the research aims to identify which sensory interventions may be most effective for individual children. Participants will undergo occupational therapy interventions over a 16-week period.
Who should consider this trial
Good fit: Ideal candidates are male children aged 6 to 8 years with a diagnosis of autism spectrum disorder and specific sensorimotor delays.
Not a fit: Patients who are female or outside the specified age range will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective sensory interventions tailored to the needs of children with autism, improving their daily functioning.
How similar studies have performed: While there have been studies on sensory interventions for autism, this approach using MRI to assess brain structure changes is relatively novel.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Stefanie Bodison
- Email: stefaniebodison@phhp.ufl.edu
- Phone: 3109903729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.