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The Listening Project: Tuning Into Change

Primary Purpose

Auditory Perceptual Disorders, Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Listening Project Protocol
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Auditory Perceptual Disorders focused on measuring autonomic nervous system, auditory processing disorder, social behavior

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • Child Trauma Service Unit, Australian Childhood Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Assessment-only group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Auditory hypersensitivity
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary Outcome Measures

Autonomic state regulation
heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Auditory processing
filtered words, competing words subscales of SCAN
social behavior
Listening Project Parent Questionnaire
Middle ear muscle transfer function
MESAS (Middle Ear Sound Absorption System)

Full Information

First Posted
February 10, 2014
Last Updated
August 24, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Australian Childhood Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02064257
Brief Title
The Listening Project: Tuning Into Change
Official Title
The Listening Project: Tuning Into Change
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Australian Childhood Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Perceptual Disorders, Stress Disorder
Keywords
autonomic nervous system, auditory processing disorder, social behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment-only group
Arm Type
No Intervention
Arm Description
The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.
Intervention Type
Behavioral
Intervention Name(s)
Listening Project Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Auditory hypersensitivity
Description
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Time Frame
pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary Outcome Measure Information:
Title
Autonomic state regulation
Description
heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Title
Auditory processing
Description
filtered words, competing words subscales of SCAN
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Title
social behavior
Description
Listening Project Parent Questionnaire
Time Frame
post-intervention (within 1 week after the intervention), 1 month post-intervention
Title
Middle ear muscle transfer function
Description
MESAS (Middle Ear Sound Absorption System)
Time Frame
pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keri J Heilman, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Trauma Service Unit, Australian Childhood Foundation
City
Ringwood
State/Province
Victoria
ZIP/Postal Code
3134
Country
Australia

12. IPD Sharing Statement

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The Listening Project: Tuning Into Change

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