Trial Outcomes & Findings for The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses (NCT NCT05009095)

Only children with ASD and auditory SOR ages 5 - 10 were recruited and considered enrolled for this study. Parents/caregivers are not considered enrolled and not the study subject population. Flyers were posted at the system's outpatient rehabilitation and therapy clinics and also given to parents of children who met inclusion criteria and interested in the study. Some parents learned about the study from ClinicalTrials.gov and reached out to study team to request participation in the study.

Race and Ethnicity were not collected from any participant.

The ABAS-3 measures adaptive skills and provides a General Adaptive Composite, which is the overall score summarizing an individual's adaptive functioning. The ABAS-3 is a norm-referenced test and the General Adaptive Composite is a standard score with a mean of 100 and a standard deviation of 15, with practical score ranges typically from \~40 to \~160. Higher scores represent improvement, or higher levels of function; lower scores represent lower levels of function. Scores between 90 - 109 are considered to be average, scores between 80 - 89 are below average, scores between 71 - 79 are low, and scores of 70 or less are extremely low.

The PEDI-CAT measures functional abilities, and the ASD module has been adapted for use with children and youth with ASD. This study used the Daily Activities and Social/Cognitive domains of the PEDI-CAT (ASD). The PEDI-CAT (ASD) provides a scaled score (converted from raw responses using domain-specific (IRT) item-response parameters) for each domain - this score is not norm-referenced, so does not compare children to same-aged peers. For each domain, the minimum scaled score is 20 and the maximum is 80. Higher scores represent improvement, or higher levels of function; lower scores represent lower levels of function.

The Sensory Processing Measure (SPM) measures sensory integration/sensory processing. This study used the Home Form, which gathered information about participants' behavior, coordination, and participation at home. The SPM provides a Total Sensory System score, which is an overall score summarizing an individual's sensory processing. The SPM is a norm-referenced test and the Total Sensory System score is a T-score with a mean of 50 and a standard deviation of 10 (scale range- 20 to 80). Lower scores represent improvement, or less sensory dysfunction; higher scores represent higher levels of sensory dysfunction. Scores between 40 - 59 represent typical performance, scores between 60 - 69 represent some problems, and scores between 70 - 80 represent a definite dysfunction with sensory processing.

The ATEC is a 77-item assessment tool developed at the Autism Research Institute. It was developed to provide a free, easily accessible, and valid tool to measure changes in ASD symptoms over time. The ATEC consists of four subtest scales: Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical Behavior. The four subscale scores are used to calculate a total score (77 items - score range 0 to 180). A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD. Baseline scores can be compared with post-intervention scores to assist with determining intervention efficacy.