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NCT Number: NCT02398422

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.

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Key information

Conditions

Auditory Perceptual Disorders Auditory Diseases, Central Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Ear Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Perceptual Disorders Retrocochlear Diseases Signs and Symptoms Social Behavior Stress Disorder Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reiss-Davis / Vista del Mar Child and Family Services

Los Angeles, California, 90034, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Listening Project Protocol

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Reiss-Davis Child Study Center of Vista Del Mar

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2015
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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