Clinical trial NCT02680730: The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
Official title: The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Perceptual Disorders
Stress Disorder
Keywords: Autonomic nervous system
Auditory processing disorder
Social behavior
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: ADD Centre© and Biofeedback Institute of Toronto©
First posted: 2016-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Secondary outcomes:
measure: Change from baseline in state regulation at 1 week, and at 1 month
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
measure: Change from baseline in auditory processing at 1 week, and at 1 month
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
measure: Change from baseline in social behavior at 1 week, and at 1 month
timeFrame: post-intervention (within 1 week after the intervention), 1 month post-intervention
measure: Change from baseline in middle ear transfer function at 1 week, and at 1 month
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
measure: Change from baseline in prosody at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
measure: Change from baseline in attention at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
measure: Change from baseline in attention (task) at 1 week, and at 2 months
timeFrame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: ADD Centre and Biofeedback Institute of Toronto
state: Ontario
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Keri J Heilman, PhD
role: PRINCIPAL_INVESTIGATOR
References: