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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Change from baseline in auditory hypersensitivity at 1 week, and at 1 month [ Time Frame: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in state regulation at 1 week, and at 1 month [ Time Frame: 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 auditory processing at 1 week, and at 1 month [ Time Frame: 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 social behavior at 1 week, and at 1 month [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention ]
    Connors Questionnaire
  • Change from baseline in attention (task) at 1 week, and at 2 months [ Time Frame: 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")


Original Secondary Outcome:

  • Change from baseline in state regulation at 1 week, and at 1 month [ Time Frame: 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 auditory processing at 1 week, and at 1 month [ Time Frame: 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
  • Change from baseline in social behavior at 1 week, and at 1 month [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention ]
    Connors Questionnaire
  • Change from baseline in attention (task) at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention ]
    IVA (computer-based task)


Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: February 8, 2016
Date Started: August 2016
Date Completion: August 2017
Last Updated: July 8, 2016
Last Verified: July 2016