The Listening Project: Tuning Into Change

Not Applicable

Completed

• Conditions: Auditory Perceptual Disorders; Stress Disorder
• Interventions: Behavioral: Listening Project Protocol

• Registration Number: NCT02064257
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-17
• Study Start: 2014-10
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Listening Project Protocol	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Child Trauma Service Unit, Australian Childhood Foundation; 🇦🇺 Ringwood, Victoria, Australia