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

NCT02398422 | Completed

• 1 other identifier: 14-3268
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Perceptual Disorders; Stress Disorder

Keywords

Autonomic nervous system; Auditory processing disorder; Social behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in state regulation at 1 week, and at 2 months

  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

  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

  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

  post-intervention (within 1 week after the intervention), 2 months post-intervention

Other Outcomes (2)

• Change from baseline in classroom behavior at 1 week, and at 2 months

  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

  pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention

Study Arms (3)

Filtered Music Intervention

EXPERIMENTAL

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

Nonfiltered Music Intervention

EXPERIMENTAL

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

Assessment-only

NO INTERVENTION

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

Interventions

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.

Filtered Music Intervention; Nonfiltered Music Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Reiss-Davis Child Study Center of Vista Del Mar: collaborator

Study Sites (1)

Reiss-Davis / Vista del Mar Child and Family Services

Los Angeles, California, 90034, United States

Location

MeSH Terms

Conditions

Auditory Perceptual Disorders; Stress Disorders, Traumatic; Social Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Keri J Heilman, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 25, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

US (1)