NCT04427150

Brief Summary

The proposed study aims to examine the abilities of children with ASD to recognize emotional tones of voice - also known as affective prosody - as compared to typically developing (TD) children. Past findings are mixed, and although some studies have found intact performance among individuals with ASD, it is possible that they rely on different underlying mechanisms in processing affective prosody compared to TD children. Our second objective is therefore to examine whether children with ASD have a stronger reliance on psychoacoustic abilities - including rapid auditory processing and pitch direction recognition - to identify emotional stimuli, as compared to TD children. Lastly, the investigators will study whether auditory training targeting psychoacoustic abilities would improve affective prosody recognition among children with ASD. Sixty children with ASD and 60 TD children between 10 to 12 years old will be recruited. Participants' psychoacoustic abilities and affective prosody recognition will be assessed in the pretest. The investigators hypothesize that psychoacoustic abilities are stronger predictors of affective prosody recognition among children with ASD than among TD children. The ASD children will then be randomly assigned to two groups: one group will receive auditory training; the other will be an active control group that receives non-auditory training. Both groups will receive 12 hours of training via a mobile app. The children will be assessed again in the posttest.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

June 1, 2020

Last Update Submit

March 15, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Accuracy of Affective Prosody Recognition

    Measures the change in the participants' ability in identifying emotional tone of words or sentences (sound stimuli). The participant will be tested before intervention and after intervention. For each test, participants will listen to word or sentences, which are pre-recorded by voice actors, then identify the emotional tone (happy, anger, fear, sad, or neutral) of the stimuli by pressing the corresponding keys on the keyboard. The accuracy of response will be used to assess the participants' ability.

    Before & after 8-week intervention program

  • Change in Ability in Discriminating Pitch Differences

    Measures the change the participants' ability in discriminating the pitch between two tones using the Pitch Discrimination Recognition task. The participant will be tested before intervention and after intervention. For each test, participants will listen to two tones and will be required to identify which tone has the higher pitch. The pitch difference between the two tones will change using a "two-down one-up" mechanism with a step-wise adjustment, which means the pitch difference will decrease every two consecutive correct responses or increase for every incorrect response. For every reversal (change from decrease to increase or vice versa) of stimuli, the latest pitch difference will be recorded. The average pitch difference of the final 8 reversals will be used to assess the participants' pitch discrimination ability. Lesser difference indicate stronger ability in discriminating the pitch between two tones.

    Before & after 8-week intervention program

  • Change in Accuracy in Processing Rapid Presentation of Two Tones

    Measures the change in the participants' ability in processing two rapid tones using the Rapid Auditory Processing task. The participant will be tested before intervention and after intervention. Two complex tones with fundamental frequency of 100Hz (Low tone) and 305Hz (High tone), each 75ms in duration, will be used throughout the entire test. For each trial, the participant will listen to two tones at ISI of 4ms, 8ms, or 30ms. The participants will be required to replicate the sequence of High or Low tones in each trial as quickly as possible. The accuracy of replicating the sequence will be used to assess the participants' ability.

    Before & after 8-week intervention program

Study Arms (3)

Auditory Training Group

EXPERIMENTAL

12 hours of psychoacoustic training over 8 weeks

Behavioral: Auditory Training

Other Training Group

ACTIVE COMPARATOR

12 hours of non-psychoacoustic training over 8 weeks

Behavioral: Non-auditory training

TD Group

NO INTERVENTION

Interventions

A series of psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes

Auditory Training Group

A series of non-psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes

Other Training Group

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Cantonese as mother language
  • IQ \> 70
  • Children with autism spectrum disorder

You may not qualify if:

  • Children diagnosed with dyslexia
  • Prior diagnosis of mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Learning Science

Kowloon Tong, Hong Kong

Location

Related Publications (33)

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    PMID: 25379450BACKGROUND
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    PMID: 25428545BACKGROUND
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    PMID: 18633780BACKGROUND
  • Grossman RB, Tager-Flusberg H. "Who said that?" Matching of low- and high-intensity emotional prosody to facial expressions by adolescents with ASD. J Autism Dev Disord. 2012 Dec;42(12):2546-57. doi: 10.1007/s10803-012-1511-2.

    PMID: 22450703BACKGROUND
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    PMID: 24335115BACKGROUND
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    PMID: 19545576BACKGROUND
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    PMID: 22399449BACKGROUND
  • Jones CR, Pickles A, Falcaro M, Marsden AJ, Happe F, Scott SK, Sauter D, Tregay J, Phillips RJ, Baird G, Simonoff E, Charman T. A multimodal approach to emotion recognition ability in autism spectrum disorders. J Child Psychol Psychiatry. 2011 Mar;52(3):275-85. doi: 10.1111/j.1469-7610.2010.02328.x. Epub 2010 Oct 18.

    PMID: 20955187BACKGROUND
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    PMID: 25178987BACKGROUND
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    PMID: 20488823BACKGROUND
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    PMID: 23245216BACKGROUND
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    PMID: 5541744BACKGROUND
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    PMID: 16639533BACKGROUND
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    PMID: 24634421BACKGROUND
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    PMID: 11521783BACKGROUND
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    PMID: 22494084BACKGROUND
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    PMID: 12108620BACKGROUND
  • Santos A, Joly-Pottuz B, Moreno S, Habib M, Besson M. Behavioural and event-related potentials evidence for pitch discrimination deficits in dyslexic children: improvement after intensive phonic intervention. Neuropsychologia. 2007 Mar 14;45(5):1080-90. doi: 10.1016/j.neuropsychologia.2006.09.010. Epub 2006 Nov 30.

    PMID: 17140611BACKGROUND
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    PMID: 16321562BACKGROUND
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    PMID: 23045218BACKGROUND
  • Wiethoff S, Wildgruber D, Kreifelts B, Becker H, Herbert C, Grodd W, Ethofer T. Cerebral processing of emotional prosody--influence of acoustic parameters and arousal. Neuroimage. 2008 Jan 15;39(2):885-93. doi: 10.1016/j.neuroimage.2007.09.028. Epub 2007 Sep 22.

    PMID: 17964813BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ann M Lui, PhD

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 120 participants (60 children with autism spectrum disorder and 60 typically developed children) will form three groups: Group 1 will contain 30 children with autism spectrum disorder (randomly selected) whom will partake in psychoacoustic intervention training. Group 2 will contain 30 children with autism spectrum disorder (randomly selected) whom will partake in non-psychoacoustic intervention training. Group 3 will contain 60 typically developed children whom will not partake in any training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 11, 2020

Study Start

September 25, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Anonymous individual participant data will be uploaded to an publicly accessible database should the results were published as a journal article.

Time Frame
Data will be provided when a journal article is published for indefinite time
Access Criteria
Access to the data will be made public. The link to the database will be provided in the journal article.

Locations