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

Not Applicable

Completed

• Conditions: Auditory Perceptual Disorders; Stress Disorder
• Interventions: Behavioral: Listening Project Protocol

• Registration Number: NCT02398422
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-25
• Study Start: 2015-10
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonfiltered Music Intervention	Listening Project Protocol	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.
Filtered Music Intervention	Listening Project Protocol	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in auditory hypersensitivity at 1 week, and at 2 months	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

Name	Time	Method
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	filtered words, competing words subscales of SCAN
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	heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
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	Middle Ear Sound Absorption System (MESAS)
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	Listening Project Parent Questionnaire

Trial Locations

Locations (1)

Reiss-Davis / Vista del Mar Child and Family Services; 🇺🇸 Los Angeles, California, United States