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

Trial Information
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
Summary

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).

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
7
Maximum Age:
55
Healthy Volunteers:
No

• Individuals must be between ages 7-55 years

• Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.

• Individuals must be current or past clients at the ADD Centres Limited & Biofeedback Institute of Toronto

Where is this trial taking place?
Other Locations
Canada
ADD Centre and Biofeedback Institute of Toronto
Recruiting
Mississauga
Who do I contact about this trial?
Primary
Keri J Heilman, PhD
keri_heilman@med.unc.edu
919-843-2220
Backup
Lynda Thompson, PhD
lyndathom@gmail.com
905 803-8066
When is this trial taking place?
Start Date: September 1, 2018
Estimated Completion Date: December 2022
How many participants will be in this trial?
Target number of participants: 30
What treatment is being studied in this trial?
Experimental: Intervention only
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.
Experimental: Intervention + Stability
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.
Who are the authors of this trial?
Keri J Heilman

This content was sourced from clinicaltrials.gov

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