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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT02398422

Collaborator

Reiss-Davis Child Study Center of Vista Del Mar (Other)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Auditory Perceptual Disorders Stress Disorder	Behavioral: Listening Project Protocol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Filtered Music Intervention 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 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.
Experimental: Nonfiltered Music Intervention 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 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.
No Intervention: Assessment-only The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.

Arm

Intervention/Treatment

Experimental: Filtered Music Intervention

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

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.

Experimental: Nonfiltered Music Intervention

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

No Intervention: Assessment-only

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

Outcome Measures

Primary Outcome Measures

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

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 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 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
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)

Other Outcome Measures

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]
Teacher-completed ASEBA
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]
Caregiver-completed ASEBA

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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