The Listening Project: Tuning Into Change

NCT02064257 | Completed

• 1 other identifier: 13-2304
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Perceptual Disorders; Stress Disorder

Keywords

autonomic nervous system; auditory processing disorder; social behavior

Outcome Measures

Primary Outcomes (1)

• Auditory hypersensitivity

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

  pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

Secondary Outcomes (4)

• Autonomic state regulation

  pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

• Auditory processing

  pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

• social behavior

  post-intervention (within 1 week after the intervention), 1 month post-intervention

• Middle ear muscle transfer function

  pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Assessment-only group

NO INTERVENTION

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

Interventions

Listening Project Protocol BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Australian Childhood Foundation: collaborator

Study Sites (1)

Child Trauma Service Unit, Australian Childhood Foundation

Ringwood, Victoria, 3134, Australia

Location

MeSH Terms

Conditions

Auditory Perceptual Disorders; Stress Disorders, Traumatic; Social Behavior

Condition Hierarchy (Ancestors)

Auditory Diseases, Central; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Trauma and Stressor Related Disorders; Behavior

Study Officials

• Keri J Heilman, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 17, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

AU (1)