The Listening Project: Tuning Into Change

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorder; Auditory Perceptual Disorders
• Intervention / Treatment: Behavioral: Listening Project Protocol

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Ringwood, Victoria, Australia, 3134
      • Child Trauma Service Unit, Australian Childhood Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• Children who wear a hearing-device
• Children with a history of heart disease
• Children who are currently being treated for seizure disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auditory hypersensitivity	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)	pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic state regulation	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), 1 month post-intervention
Auditory processing	filtered words, competing words subscales of SCAN	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
social behavior	Listening Project Parent Questionnaire	post-intervention (within 1 week after the intervention), 1 month post-intervention
Middle ear muscle transfer function	MESAS (Middle Ear Sound Absorption System)	pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Australian Childhood Foundation
• Investigators: Principal Investigator: Keri J Heilman, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: autonomic nervous system; social behavior; auditory processing disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Cognition Disorders; Retrocochlear Diseases; Auditory Diseases, Central; Disease; Perceptual Disorders; Auditory Perceptual Disorders
• Other Study ID Numbers: 13-2304