COMPLETED

Sensory Intervention for Children With Autism

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessing Heterogeneity of Treatment Response in Children With Autism Spectrum Disorder

Quick Facts

Study Start:2024-01-16

Study Completion:2025-06-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06246487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 9 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-16

Study Completion Date2025-06-24

Study Record Updates

Study Start Date2024-01-16

Study Completion Date2025-06-24

Terms related to this study

Additional Relevant MeSH Terms

Autism Spectrum Disorder