The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

Study Overview
=================
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.

Official Title
-----------------
The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

Conditions
-----------------
Auditory Perceptual Disorders, Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Listening Project Protocol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filtered Music Intervention<br>Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days. | Behavioral: Listening Project Protocol<br>* The filtered-music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing. The non-filtered music intervention will consist of the same music as the filtered-music intervention.<br>|
| Experimental: Nonfiltered Music Intervention<br>Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention (nonfiltered music). The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days. | Behavioral: Listening Project Protocol<br>* The filtered-music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing. The non-filtered music intervention will consist of the same music as the filtered-music intervention.<br>|
| No Intervention: Assessment-only<br>The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in auditory hypersensitivity at 1 week, and at 2 months | Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire) | pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in state regulation at 1 week, and at 2 months | heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia | pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention | 
| Change from baseline in auditory processing at 1 week, and at 2 months | filtered words, competing words subscales of SCAN | pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention | 
| Change from baseline in social behavior at 1 week, and at 2 months | Listening Project Parent Questionnaire | post-intervention (within 1 week after the intervention), 2 months post-intervention | 
| Change from baseline in middle ear transfer function at 1 week, and at 2 months | Middle Ear Sound Absorption System (MESAS) | post-intervention (within 1 week after the intervention), 2 months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autonomic nervous system, Auditory processing disorder, Social behavior