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

Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398422
• Other study ID #: 14-3268
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Disease
• Perceptual Disorders
• Stress Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Reiss-Davis / Vista del Mar Child and Family Services	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Reiss-Davis Child Study Center of Vista Del Mar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in classroom behavior at 1 week, and at 2 months	Teacher-completed ASEBA	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Other	Change from baseline in home behavior at 1 week, and at 2 months	Caregiver-completed ASEBA	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Primary	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	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	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Secondary	Change from baseline in auditory processing at 1 week, and at 2 months	filtered words, competing words subscales of SCAN	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention
Secondary	Change from baseline in social behavior at 1 week, and at 2 months	Listening Project Parent Questionnaire	post-intervention (within 1 week after the intervention), 2 months post-intervention
Secondary	Change from baseline in middle ear transfer function at 1 week, and at 2 months	Middle Ear Sound Absorption System (MESAS)	post-intervention (within 1 week after the intervention), 2 months post-intervention