Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001359325p
Ethics application status
Submitted, not yet approved
Date submitted
11/09/2017
Date registered
27/09/2017
Date last updated
27/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Decreasing Defensive Responses: Investigating the Safe & Sound Protocol (SSP) to improve emotional regulation, communication, and social engagement with children with Autism.
Scientific title
Investigating the effects of the Safe & Sound Protocol (SSP) on frontal alpha asymmetry and motor skills in children aged 8-14 years with Autism.
Secondary ID [1] 292700 0
Nil
Universal Trial Number (UTN)
1111-1201-0768
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 304456 0
Condition category
Condition code
Mental Health 303792 303792 0 0
Autistic spectrum disorders
Neurological 304043 304043 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 304044 304044 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298938 0
Treatment: Devices
Intervention code [2] 298939 0
Behaviour
Comparator / control treatment
This research will utilize an active control group.
The active control group will receive the nonfiltered music intervention- participants will listen to the same music selections as intervention group but the music has not been electronically filtered/modified.
Control group
Active

Outcomes
Primary outcome [1] 303152 0
Primary Outcome 1- EEG analysis of frontal alpha asymmetry.
Percentage of change will be calculated at each time point.
Timepoint [1] 303152 0
Time Points: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Primary outcome [2] 303153 0
Primary Outcome 2- EEG analysis of frontotemporal connectivity.
Percentage of change will be calculated at each time point.
Timepoint [2] 303153 0
Time Points: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Primary outcome [3] 303154 0
Primary Outcome 3- Resting state ECG- Heart Rate Variability- Heart period analysis
Percentage of change will be calculated at each time point.
Timepoint [3] 303154 0
Time Points: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Secondary outcome [1] 338049 0
Social Responsiveness Scale (SRS, Constantino and Gruber 2005)
Composite score will be calculated and percentage of change over timepoints will be analysed
Timepoint [1] 338049 0
Time Points: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Secondary outcome [2] 338050 0
Motor Abilities:
Bruininks Test of Motor Proficiency

Percentage of change will be calculated.
Timepoint [2] 338050 0
Time Ponts: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Secondary outcome [3] 338051 0
The Autism Treatment Evaluation Checklist (ATEC) (B Rimland & Edelson, 2002)
Outcome- Percentage change over timepoints
Timepoint [3] 338051 0
Time Points: pre-intervention (within 1 week before intervention), 2 months post-intervention.
Secondary outcome [4] 338052 0
PROSODY (Brain and Body Centre, University of North Carolina, Chapel Hill, NC
“PROSODY” is a recently developed measure.
Participants will be asked to tell a short (at least 20 seconds) story of a positive experience (in school, work or home); the story will be recorded using a microphone. Participants will then be asked to tell a story of a negative experience (once again, to capture at least 20 seconds of dialog). Prosodic features of the recording will be measured by a multi-stage quantitative analysis.
Outcome- percent change in frequency range over timepoints
Timepoint [4] 338052 0
Time Ponts: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Secondary outcome [5] 338616 0
SCAN- 3 test of Auditory Processing- filtered words, & competing words subscales
Timepoint [5] 338616 0
Time Ponts: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Secondary outcome [6] 338617 0
Brain-Body Center Sensory Scales (BBC Auditory Sensory Scales) (parental questionnaire)
Timepoint [6] 338617 0
Time Ponts: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Secondary outcome [7] 338882 0
Beery Buktenica Developmental Test of Visual Motor Integration 6th Edition (Beery VMI).
Timepoint [7] 338882 0
Time Ponts: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention
Secondary outcome [8] 338883 0
DARE (“Dynamic Affect Recognition Evaluation”) Brain and Body Centre, University of North Carolina, Chapel Hill, NC.
Timepoint [8] 338883 0
Time Ponts: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), and endpoint, 2 months post-intervention

Eligibility
Key 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
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation Concealed
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Validation of group size.
Using G-Power 3.1 software; running a t-test with effect size of 0.5, alpha at 0.05; a total sample size of 34 per group is required for a power of .80. Two intervention conditions are employed requiring a total of 68 participants.

Statistical analysis will employ different methodology for within subject and between group analysis.
QEEG Analysis
EEG raw recording will be uploaded to NeuroGuide (http://www.appliedneuroscience.com/research.htm) for editing (reliability level of 0.9) and analysis. Analyse includes across frequency bandwidths, (delta, theta, alpha, beta, gamma), in 1 htz bins for power, magnitude, phase and connectivity across cortical areas. Topographical power maps are generated:
NeuroStat: software will process repeat measures analysis of variance (ANOVA) and paired t-tests, pre-vs- post intervention.
NeuroBatch: processes group comparison statistics. Differences between groups will be analzed.
ECG will be assessed with Biopac MP150 Nomadic physiological acquisition (Biopac Systems, Inc., Santa Barbara, CA).
The ECG and heart period data will be visually inspected and edited offline with CardioEdit software (Brain-Body Center, University of Illinois at Chicago). Editing will consist of integer arithmetic (i.e., dividing intervals between heart beats when detections of R-wave from the ECG were missed or adding intervals when spuriously invalid detections occurred). RSA will be calculated with CardioBatch software (Brain-Body Center, University of Illinois at Chicago) consistent with procedures developed by Porges (1985). The Porges method quantifies the amplitude of RSA with age specific parameters that are sensitive to the maturational shifts in the frequency of breathing.
Voice Prosody
Data will be assessed via Prosody software (Brain-Body Lab). Prosodic features of speech will be measured by a multi-stage quantitative analysis of the digitized voice recordings.
SPSS software will be utilized for repeat measures ANOVA for within and between group comparisons. Comparative analysis will include:
1. Motor measures to RSA to answer the question of is there a relationship between vagal regulation of the heart (state regulation) and motor skills?
2. Motor measures and social scales to answer the question of is there a relationship between pro-social behaviours and motor skills?
3. Frontal asymmetry and pro social and motor skills?
4. Connectivity and prosocial social
5. Auditory sensitivities and motor skills

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2017
Actual
Date of last participant enrolment
Anticipated
10/08/2018
Actual
Date of last data collection
Anticipated
26/10/2018
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297340 0
University
Name [1] 297340 0
LaTrobe University
Country [1] 297340 0
Australia
Primary sponsor type
University
Name
LaTrobe University
Address
LaTrobe University
School of Psychological Sciences
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country
Australia
Secondary sponsor category [1] 296478 0
None
Name [1] 296478 0
Address [1] 296478 0
Country [1] 296478 0
Other collaborator category [1] 279677 0
Individual
Name [1] 279677 0
Dr. Stephen Porges
Address [1] 279677 0
Department of Psychiatry
UNC Hospitals - Chapel Hil
101 Manning Dr, Chapel Hill, NC, USA 27514
Country [1] 279677 0
United States of America
Other collaborator category [2] 279707 0
Individual
Name [2] 279707 0
Dr. Keri Heilman
Address [2] 279707 0
Department of Psychiatry
UNC Hospitals - Chapel Hil
101 Manning Dr, Chapel Hill, NC, USA 27514
Country [2] 279707 0
Australia
Other collaborator category [3] 279710 0
Individual
Name [3] 279710 0
Dr. Darren Hocking
Address [3] 279710 0
Senior Research Fellow, ARC DECRA Fellow
College of Science, Health and Engineering
School of Psychology and Public Health
Department of Psychology and Counselling
Biological Sciences Building 2, Level 1, Room 119,
La Trobe University,
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country [3] 279710 0
Australia
Other collaborator category [4] 279711 0
Individual
Name [4] 279711 0
Dr. Darren Hedley
Address [4] 279711 0
Research Fellow
College of Science, Health and Engineering
School of Psychology and Public Health
Department of Psychology and Counselling
La Trobe University
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country [4] 279711 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298440 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 298440 0
La Trobe University
The University Human Ethics Committee (UHEC)
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Ethics committee country [1] 298440 0
Australia
Date submitted for ethics approval [1] 298440 0
21/09/2017
Approval date [1] 298440 0
Ethics approval number [1] 298440 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2046 2046 0 0
/AnzctrAttachments/373510(v11-09-2017-16-50-46)-Ethics- PIS- Parent for Child Particpation Sept 7.docx (Participant information/consent)
Attachments [2] 2047 2047 0 0
/AnzctrAttachments/373510-Ethics- Child Assent form Sept 7-1.docx (Participant information/consent)

Contacts
Principal investigator
Name 77098 0
Ms Joanne McIntyre, OT, MS, PhD Candidate
Address 77098 0
LaTrobe University
School of Psychological Sciences
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country 77098 0
Australia
Phone 77098 0
+61 413 738 958
Fax 77098 0
Email 77098 0
J.McIntyre@latrobe.edu.au
Contact person for public queries
Name 77099 0
Ms Joanne McIntyre OT, MS, PhD Candidate
Address 77099 0
LaTrobe University
School of Psychological Sciences
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country 77099 0
Australia
Phone 77099 0
+61 413 738 958
Fax 77099 0
Email 77099 0
J.McIntyre@latrobe.edu.au
Contact person for scientific queries
Name 77100 0
Ms Joanne McIntyre OT, MS, PhD Candidate
Address 77100 0
LaTrobe University
School of Psychological Sciences
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country 77100 0
Australia
Phone 77100 0
+61 413 738 958
Fax 77100 0
Email 77100 0
J.McIntyre@latrobe.edu.au

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