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

University of North Carolina (UNC)

Status: Completed

Conditions: Auditory Perceptual Disorders; Stress Disorder

Treatments: Behavioral: Listening Project Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02398422

14-3268

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Filtered Music Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Listening Project Protocol

Nonfiltered Music Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Listening Project Protocol

Assessment-only

No Intervention group

Description:

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