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

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorder; Auditory Perceptual Disorders
• Intervention / Treatment: Behavioral: Listening Project Protocol

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90034
      • Reiss-Davis / Vista del Mar Child and Family Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Filtered Music Intervention; 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; 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.
Experimental: Nonfiltered Music Intervention; 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; 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.
No Intervention: Assessment-only; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in classroom behavior at 1 week, and at 2 months	Teacher-completed ASEBA	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Change from baseline in home behavior at 1 week, and at 2 months	Caregiver-completed ASEBA	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Reiss-Davis Child Study Center of Vista Del Mar
• Investigators: Principal Investigator: Keri J Heilman, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 19, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Social behavior; Auditory processing disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Cognition Disorders; Retrocochlear Diseases; Auditory Diseases, Central; Disease; Perceptual Disorders; Auditory Perceptual Disorders
• Other Study ID Numbers: 14-3268