The Listening Project: Tuning Into Change

Study Overview
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Brief Summary
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A research project funded by the Australian Childhood Foundation (ACF) will be conducted in Australian facilities of the ACF to evaluate the effectiveness of the Listening Project Protocol (LPP) in children with a trauma history. 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 and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, and sensory symptoms.

Official Title
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The Listening Project: Tuning Into Change

Conditions
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Auditory Perceptual Disorders, Stress Disorder

Intervention / Treatment
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* Behavioral: Listening Project Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children must be between ages 7-14 years Children and parent providing permission must be able to read/speak in English Children must be receiving services from the Child Trauma Service unit of the Australian Childhood Foundation Exclusion Criteria: Children who wear a hearing-device Children with a history of heart disease Children who are currently being treated for seizure disorder

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: Intervention group<br>Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention. The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days. | Behavioral: Listening Project Protocol<br>* The 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.<br>|
| No Intervention: Assessment-only group<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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory hypersensitivity | Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire) | pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic state regulation | 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), 1 month post-intervention | 
| Auditory processing | filtered words, competing words subscales of SCAN | pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention | 
| social behavior | Listening Project Parent Questionnaire | post-intervention (within 1 week after the intervention), 1 month post-intervention | 
| Middle ear muscle transfer function | MESAS (Middle Ear Sound Absorption System) | pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auditory processing disorder, social behavior, autonomic nervous system