The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
- Conditions
- Auditory Perceptual DisordersStress Disorder
- Interventions
- Behavioral: Listening Project Protocol
- Registration Number
- NCT02680730
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
Exclusion criteria:
- Individuals who wear a hearing-device
- Individuals with a history of heart disease
- Individuals who are currently being treated for seizure disorder
- Individuals who are non-verbal
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention + Stability Listening Project Protocol 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. Intervention only Listening Project Protocol 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.
- Primary Outcome Measures
Name Time Method Change from baseline in auditory hypersensitivity at 1 week, and at 1 month 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 Change from baseline in social behavior at 1 week, and at 1 month post-intervention (within 1 week after the intervention), 1 month post-intervention Listening Project Parent Questionnaire
Change from baseline in middle ear transfer function at 1 week, and at 1 month pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention Middle Ear Sound Absorption System (MESAS)
Change from baseline in prosody at 1 week, and at 2 months pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention Prosody assessment of recorded speech
Change from baseline in attention (task) at 1 week, and at 2 months pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention Integrated Visual and Auditory Continuous Performance Task ("IVA")
Change from baseline in auditory processing at 1 week, and at 1 month pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention filtered words, competing words subscales of SCAN-3:C Tests for Auditory Processing Processing Disorders in Children
Change from baseline in state regulation at 1 week, and at 1 month pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Change from baseline in attention at 1 week, and at 2 months pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention Connors Questionnaire
Trial Locations
- Locations (1)
ADD Centre and Biofeedback Institute of Toronto
🇨🇦Mississauga, Ontario, Canada