Clinical trial NCT02064257: The Listening Project: Tuning Into Change
Official title: The Listening Project: Tuning Into Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Perceptual Disorders
Stress Disorder
Keywords: autonomic nervous system
auditory processing disorder
social behavior
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Australian Childhood Foundation
First posted: 2014-02-17
Enrollment: 43
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Auditory hypersensitivity
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary outcomes:
measure: Autonomic state regulation
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
measure: Auditory processing
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
measure: social behavior
timeFrame: post-intervention (within 1 week after the intervention), 1 month post-intervention
measure: Middle ear muscle transfer function
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Other outcomes:
Locations:
city: Ringwood
country: Australia
facility: Child Trauma Service Unit, Australian Childhood Foundation
state: Victoria
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Keri J Heilman, PhD
role: PRINCIPAL_INVESTIGATOR
References: