The Listening Project: Tuning Into Change

University of North Carolina (UNC)

Status: Completed

Conditions: Auditory Perceptual Disorders; Stress Disorder

Treatments: Behavioral: Listening Project Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02064257

13-2304

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 7 to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Intervention group

Experimental group

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.

Treatment:

Behavioral: Listening Project Protocol

Assessment-only group

No Intervention group

Description:

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