Clinical trial NCT02398422: The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services
Official title: The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Perceptual Disorders
Stress Disorder
Keywords: Autonomic nervous system
Auditory processing disorder
Social behavior
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Reiss-Davis Child Study Center of Vista Del Mar
First posted: 2015-03-25
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.


Eligibility criteria: Inclusion Criteria:

* children must be between ages 6-17 years
* children must be able to read/speak in English. Parents must be able to read/speak in either English or Spanish
* children must be patients, students and/or residents at Reiss-Davis/Vista del Mar

Exclusion Criteria:

* children who wear a hearing device
* children with a history of heart disease
* children who are currently being treated for a seizure disorder
* children who are non-verbal

Primary outcomes:
measure: Change from baseline in auditory hypersensitivity at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention
Secondary outcomes:
measure: Change from baseline in state regulation at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
measure: Change from baseline in auditory processing at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
measure: Change from baseline in social behavior at 1 week, and at 2 months
timeFrame: post-intervention (within 1 week after the intervention), 2 months post-intervention
measure: Change from baseline in middle ear transfer function at 1 week, and at 2 months
timeFrame: post-intervention (within 1 week after the intervention), 2 months post-intervention
Other outcomes:
measure: Change from baseline in classroom behavior at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
measure: Change from baseline in home behavior at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Locations:
city: Los Angeles
country: United States
facility: Reiss-Davis / Vista del Mar Child and Family Services
state: California
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Keri J Heilman, PhD
role: PRINCIPAL_INVESTIGATOR
References: