Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398422
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
Reiss-Davis Child Study Center of Vista Del Mar
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Auditory Perceptual Disorders Stress Disorder Behavioral: Listening Project Protocol Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services
Study Start Date : October 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline in auditory hypersensitivity at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention ]
    Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)


Secondary Outcome Measures :
  1. Change from baseline in state regulation at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention ]
    heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia

  2. Change from baseline in auditory processing at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention ]
    filtered words, competing words subscales of SCAN

  3. Change from baseline in social behavior at 1 week, and at 2 months [ Time Frame: post-intervention (within 1 week after the intervention), 2 months post-intervention ]
    Listening Project Parent Questionnaire

  4. Change from baseline in middle ear transfer function at 1 week, and at 2 months [ Time Frame: post-intervention (within 1 week after the intervention), 2 months post-intervention ]
    Middle Ear Sound Absorption System (MESAS)


Other Outcome Measures:
  1. Change from baseline in classroom behavior at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention ]
    Teacher-completed ASEBA

  2. Change from baseline in home behavior at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention ]
    Caregiver-completed ASEBA


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398422


Locations
Layout table for location information
United States, California
Reiss-Davis / Vista del Mar Child and Family Services
Los Angeles, California, United States, 90034
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Reiss-Davis Child Study Center of Vista Del Mar
Investigators
Layout table for investigator information
Principal Investigator: Keri J Heilman, PhD University of North Carolina, Chapel Hill
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02398422    
Other Study ID Numbers: 14-3268
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Keywords provided by University of North Carolina, Chapel Hill:
Autonomic nervous system
Auditory processing disorder
Social behavior
Additional relevant MeSH terms:
Layout table for MeSH terms
Auditory Perceptual Disorders
Perceptual Disorders
Disease
Pathologic Processes
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders