Autism Spectrum Disorder
Conditions
Keywords
ASD, The Listening Program® with bone conduction headphones, Hypersensitivity to sound and behavioral responses
Brief summary
There are limited approaches to specifically address auditory sensory over- and under-responsivity (SOR) in children with Autism Spectrum Disorder (ASD). Exposure therapy (or systematic desensitization) may be a treatment option; researchers are investigating this approach. Many children receive sensory integration therapy, but this approach does not specifically target auditory SOR. Some families are advised to have their children avoid noxious stimuli or use compensatory techniques such as wearing headphones or ear plugs. While preliminary research suggests that use of noise attenuating headphones may reduce sympathetic activation for children with ASD and auditory SOR, this approach does not seek to change or alter the underlying cause of sympathetic activation (Pfeiffer et al., 2019). Sound-based interventions are promising options to treat hyperacusis and subsequent auditory SOR in children with ASD. The objective of this study is to investigate changes in adaptive life skills and behavioral responses in children with ASD using Advanced Brain Technology's The Listening Program ® Spectrum music utilizing Waves ™ (bone conduction) headphones. Our study will investigate the effects of a sound-based intervention developed in 2012 to specifically address the needs of children with ASD and children with hyperacusis and/or auditory SOR - The Listening Program® Spectrum music utilizing Waves™ (bone conduction) headphones by Advanced Brain Technologies. This program emphasizes low frequency music over an extended period of time; the duration recommended by Advanced Brain Technologies is 40 weeks.
Detailed description
Children with a diagnosis of ASD with auditory SOR to sound, ages 5 to 10 years, will be the primary patient population. The study will use a nonconcurrent AB multiple baseline design, with A representing the baseline phase and B representing the intervention phase with a postintervention non-treatment phase. At baseline (A), demographic information will be collected and the following outcome measures will be completed: the Pediatric Evaluation of Disability Inventory Computer Adaptive Test with ASD Scales (PEDI CAT- ASD), Sensory Processing Measure (SPM) home form, the Adaptive Behavioral Assessment System 3rd Edition ABAS-3 and Autism Treatment Evaluation Checklist (ATEC). During the intervention (B) phase, parents of participants in the treatment group will be educated by the investigators on use of The Listening Program at home, and then participants in this group will receive treatment at home utilizing The Listening Program for 40 weeks. Testing, using the same 4 outcome measures, will be completed at the 41st week after use, and then again after 3 months of no treatment. Between testing sessions, caregivers and investigators will set up three phone or hospital-approved virtual platform meetings at approximately 10 week intervals to check in and answer questions.
Interventions
DEVICEThe Listening Program® with bone conduction headphones
The Listening Program method of Music-Based Auditory Stimulation is enhanced with the addition of bone conduction technology with the ABT Bone Conduction System. Bone Conduction combines the experience of listening to music through modified headphones adding subtle, synchronized acoustic vibration of the skin and skeletal system, engaging the whole body and brain in the listening process. This multi-sensory approach accelerates and expands the benefits of The Listening Program.
Sponsors
Children's Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will use a nonconcurrent AB multiple baseline design, with A representing the baseline phase and B representing the intervention phase with a postintervention non-treatment phase.
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Children will be eligible to participate in this study if they are: 1. Between the ages of 5 and 10 years old 2. Diagnosis of autism spectrum disorder 3. Auditory SOR defined by "Some Problems or Definite Dysfunction" on the Hearing section on the Sensory Processing Measure Home Form. 4. Caregiver must be available to supervise listening sessions at home 5. English Speaking
Exclusion criteria
1\. Children will be excluded from the study if they are: a. Diagnosed with seizure disorder b. Hearing impairments c. Cerebral palsy d. Fragile X syndrome or genetic disease e. Previous use of a listening base system f. Non-English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Adaptive Behavior Assessment System, Third Edition Score (ABAS-3) Score | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Evaluation of Disability Inventory Computer Adaptive Test With ASD Scales (PEDI-CAT (ASD)) | To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSuzanne Vercontaire
Children's Health
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
None listed