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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Stephen Porges, PhD, University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Reiss-Davis Child Study Center of Vista Del Mar
Information provided by (Responsible Party):
Stephen Porges, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02398422
First received: March 16, 2015
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
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 Intervention
Auditory Perceptual Disorders Stress Disorder Behavioral: Listening Project Protocol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

Further study details as provided by Stephen Porges, PhD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

  • 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:
  • 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

  • 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


Estimated Enrollment: 60
Study Start Date: October 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02398422

Contacts
Contact: Stephen W Porges, PhD 919 843-2220 stephen_porges@med.unc.edu
Contact: James Incorvaia, MD 310-204-1666 ext 316 JimIncorvaia@vistadelmar.org

Locations
United States, California
Reiss-Davis / Vista del Mar Child and Family Services Recruiting
Los Angeles, California, United States, 90034
Contact: James Incorvaia, MD    310-204-1666 ext 316    JimIncorvaia@vistadelmar.org   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Reiss-Davis Child Study Center of Vista Del Mar
Investigators
Principal Investigator: Stephen W Porges, PhD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Stephen Porges, PhD, Professor of Psychiatry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02398422     History of Changes
Other Study ID Numbers: 14-3268
Study First Received: March 16, 2015
Last Updated: May 4, 2016

Keywords provided by Stephen Porges, PhD, University of North Carolina, Chapel Hill:
Autonomic nervous system
Auditory processing disorder
Social behavior

Additional relevant MeSH terms:
Disease
Perceptual Disorders
Auditory Perceptual Disorders
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2017