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

Primary Purpose

Auditory Perceptual Disorders, Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Listening Project Protocol
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Auditory Perceptual Disorders focused on measuring Autonomic nervous system, Auditory processing disorder, Social behavior

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reiss-Davis / Vista del Mar Child and Family Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Filtered Music Intervention

Nonfiltered Music Intervention

Assessment-only

Arm Description

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.

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.

The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.

Outcomes

Primary Outcome Measures

Change from baseline in auditory hypersensitivity at 1 week, and at 2 months
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary Outcome Measures

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
Change from baseline in auditory processing at 1 week, and at 2 months
filtered words, competing words subscales of SCAN
Change from baseline in social behavior at 1 week, and at 2 months
Listening Project Parent Questionnaire
Change from baseline in middle ear transfer function at 1 week, and at 2 months
Middle Ear Sound Absorption System (MESAS)

Full Information

First Posted
March 16, 2015
Last Updated
August 24, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Reiss-Davis Child Study Center of Vista Del Mar
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1. Study Identification

Unique Protocol Identification Number
NCT02398422
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Reiss-Davis Child Study Center of Vista Del Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Perceptual Disorders, Stress Disorder
Keywords
Autonomic nervous system, Auditory processing disorder, Social behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filtered Music Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Nonfiltered Music Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment-only
Arm Type
No Intervention
Arm Description
The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.
Intervention Type
Behavioral
Intervention Name(s)
Listening Project Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in auditory hypersensitivity at 1 week, and at 2 months
Description
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Time Frame
pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention
Secondary Outcome Measure Information:
Title
Change from baseline in state regulation at 1 week, and at 2 months
Description
heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Title
Change from baseline in auditory processing at 1 week, and at 2 months
Description
filtered words, competing words subscales of SCAN
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Title
Change from baseline in social behavior at 1 week, and at 2 months
Description
Listening Project Parent Questionnaire
Time Frame
post-intervention (within 1 week after the intervention), 2 months post-intervention
Title
Change from baseline in middle ear transfer function at 1 week, and at 2 months
Description
Middle Ear Sound Absorption System (MESAS)
Time Frame
post-intervention (within 1 week after the intervention), 2 months post-intervention
Other Pre-specified Outcome Measures:
Title
Change from baseline in classroom behavior at 1 week, and at 2 months
Description
Teacher-completed ASEBA
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Title
Change from baseline in home behavior at 1 week, and at 2 months
Description
Caregiver-completed ASEBA
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keri J Heilman, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reiss-Davis / Vista del Mar Child and Family Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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