None listed
Conditions
Brief summary
Studies are increasingly exploring the neurobiology of Neurodevelopmental Disorders and linking atypical neurophysiological patterns to clinical behaviour. The ability to regulate emotional state has been identified as a core feature of many psychopathologies including anxiety, attention problems, depression neurodevelopmental delays and autism (Beauchaine, 2001). The Polyvagal Theory (PVT) provides a framework for interpreting physiological systems in relation to emotional regulation for adaptive prosocial behavioural responses (S. W. Porges, 2001). Autism Spectrum Disorders (ASD) present with primary dysfunction in social interactions, communication impairments and restricted and repetitive patterns of interests and behaviours (American Psychiatric Association, 2013). Although not typically part of diagnostic criteria, auditory processing or hyperacusis are often evident in ASD and can impact emotional regulation and prosocial behaviours. ASD is a complex neurodevelopmental disorder and therapeutic interventions typically employed utilize behavioural strategies to address the range of behavioural difficulties presented. The Safe & Sound Protocol (SSP) is a novel intervention intended to impact neural systems supporting psychological experience and behaviour. Hypothesis That the Safe and Sound Protocol results in decreased auditory hypersensitivities and improved auditory processing, with associated improved autonomic and cortical neural regulation enabling prosocial behaviors.
Interventions
The Safe and Sound Protocol (developed by Dr. Stephen Porges, UNC) is a 5-day auditory-based intervention that involves listening to electronically modified/filtered music. The SSP was theoretically designed to reduce auditory hypersensitivities by recruiting the anti-masking functions of the middle ear muscles to optimize the transfer function of the middle ear for the processing of human speech. Vocal music was selected based on frequency range and prosodic features, then electronically filter
The Safe and Sound Protocol (developed by Dr. Stephen Porges, UNC) is a 5-day auditory-based intervention that involves listening to electronically modified/filtered music. The SSP was theoretically designed to reduce auditory hypersensitivities by recruiting the anti-masking functions of the middle ear muscles to optimize the transfer function of the middle ear for the processing of human speech. Vocal music was selected based on frequency range and prosodic features, then electronically filtered based on algorithms developed by his lab. These algorithms are proprietary but were developed based on an “exercise” model that uses computer altered acoustic stimulation to modulate the frequency band passed to the participant. The frequency characteristics of the protocol were theoretically selected based on the documented frequency band and weights associated with speech and language. The Protocol is delivered through headphones for 6o minutes for 5 consecutive days. An important aspect of the protocol is that the children feel safe and supported, so the environment is non-threatening and the main caregiver remains present with the researcher. The children can freely engage with manipulatives/books/drawing while listening.
Sponsors
LaTrobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: Confirmed Diagnosis of Autism IQ > 80. Children must be between ages 8-14 years Children and parent providing permission must be able to read/speak English
Exclusion criteria
Exclusion Criteria: Children who wear a hearing device Children with a history of heart disease Children who are currently being treated for seizure disorder History of head injury Presence of a neurological (e.g., epilepsy) or a genetic disorder (e.g., Fragile X), Autism Treatment Evaluation Checklist (ATEC) score above the 80th Percentile (Severe Range)
Outcome results
None listed