The Listening Project at the ADD Centre and Biofeedback Institute of Toronto

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

NCT02680730

15-1954

Details and patient eligibility

About

Purpose: A research project will be conducted at the ADD ("Attention Deficit Disorder") Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or behavioral regulation. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. These improvements should translate into increase feelings of safety and calmness, thereby promoting improvement in social behavior.

Participants: 30 participants, males and females between ages 7-55 years, will be recruited for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of Toronto.

Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and 1 month post intervention assessment. Group 2 will have an additional pre-intervention assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the stability of the measures prior to starting the intervention. Pre-, post-, and 1 month followup assessment will include parent and/or self-report questionnaires, and measures of the individual's auditory processing ("SCAN"), affect recognition ("DARE" Dynamic Affect Recognition Evaluation), heart rate, prosody, "RSA" respiratory sinus arrhythmia (derived from non-invasive ECG recording), and middle ear transfer function ("MESAS" - Middle Ear Sound Absorption System).

Enrollment: 30 patients

Sex: All

Ages: 7 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Individuals must be between ages 7-55 years
2. Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.
3. Individuals must be current or past clients at the ADD Centres Limited & Biofeedback Institute of Toronto

Exclusion criteria

1. Individuals who wear a hearing-device
2. Individuals with a history of heart disease
3. Individuals who are currently being treated for seizure disorder
4. Individuals who are non-verbal

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention only

Experimental group

Description:

Participants will be included in 1 pre-intervention and 2 post-assessment measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days.

Treatment:

Behavioral: Listening Project Protocol

Intervention + Stability

Experimental group

Description:

Participants will be included in 2 pre-intervention and 2 post-assessment measures. The additional pre-intervention assessment will allow for assessment of stability of measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days.

Treatment:

Behavioral: Listening Project Protocol