The Listening Project: Tuning Into Change

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT02064257

Collaborator

Australian Childhood Foundation (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A research project funded by the Australian Childhood Foundation (ACF) will be conducted in Australian facilities of the ACF to evaluate the effectiveness of the Listening Project Protocol (LPP) in children with a trauma history. 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 and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, and sensory symptoms.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Listening Project: Tuning Into Change

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention. The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days.	Behavioral: Listening Project Protocol The 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.
No Intervention: Assessment-only group 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: Intervention group

Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention. The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days.

Behavioral: Listening Project Protocol

The 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.

No Intervention: Assessment-only group

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

Auditory hypersensitivity [pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention]
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary Outcome Measures

Autonomic state regulation [pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention]
heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Auditory processing [pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention]
filtered words, competing words subscales of SCAN
social behavior [post-intervention (within 1 week after the intervention), 1 month post-intervention]
Listening Project Parent Questionnaire
Middle ear muscle transfer function [pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention]
MESAS (Middle Ear Sound Absorption System)

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children must be between ages 7-14 years
Children and parent providing permission must be able to read/speak in English
Children must be receiving services from the Child Trauma Service unit of the Australian Childhood Foundation