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)
43
1
2
59
0.7

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
  • 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. social behavior [post-intervention (within 1 week after the intervention), 1 month post-intervention]

    Listening Project Parent Questionnaire

  4. 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:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Child Trauma Service Unit, Australian Childhood Foundation Ringwood Victoria Australia 3134

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • Australian Childhood Foundation

Investigators

  • Principal Investigator: Keri J Heilman, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02064257
Other Study ID Numbers:
  • 13-2304
First Posted:
Feb 17, 2014
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Keywords provided by University of North Carolina, Chapel Hill
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2021