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Affective Prosody Recognition and Auditory Intervention for Children With Autism Spectrum Disorders (ASD)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Auditory Training
Non-auditory training
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Children diagnosed with dyslexia
  • Prior diagnosis of mental disorders

Sites / Locations

  • Centre of Learning Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Auditory Training Group

Other Training Group

TD Group

Arm Description

12 hours of psychoacoustic training over 8 weeks

12 hours of non-psychoacoustic training over 8 weeks

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2020
Last Updated
March 15, 2022
Sponsor
Hong Kong Baptist University
Collaborators
The Hong Kong Polytechnic University, Education University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04427150
Brief Title
Affective Prosody Recognition and Auditory Intervention for Children With Autism Spectrum Disorders (ASD)
Official Title
Examining Affective Prosody Recognition Among Children With Autism Spectrum Disorders and the Effectiveness of an Auditory Intervention Using a Mobile App
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
The Hong Kong Polytechnic University, Education University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Participants will sign an informed consent statement prior to arriving at the lab. Participants with ASD will be randomly assigned into either the auditory training group (Group 1) or the active control group (Group 2). Participants without ASD will be assigned to the typically developed group (Group 3). Groups 1 and 2 will complete all stages of the study, whereas Group 3 will only complete the pre-test stage. Pre-test: Researchers will assess participants' affective prosody recognition ability and psychoacoustic ability. The tests will be conducted in a sound attenuated lab located at Hong Kong Baptist University. The tests include an affective prosody recognition test, a pitch discrimination recognition test, a rapid auditory processing test, and a theory of mind test. Intervention Training: Participants will be required to partake in an intervention training program. The program will adopt training exercises provided by Posit Science - BrainHQ. The participants will be asked to complete a training session of 15-30 minutes each day for 8 weeks, arriving at a total of at least 8 hours of training. The progress of intervention training will be closely monitored by the research team. Post-test: Participant will be asked to return to the lab for post-test assessment of the same tests, and complete an autism assessment (ADOS-2) and intelligence assessment (WISC-IV) conducted by a clinical psychologist, as well as a non-verbal Intelligence test (KBIT-2) conducted by a trained researcher. Note: For ethical and fairness purposes, participants from Group 2 will be allowed to access the intervention training after Post-test. To encourage completion of the intervention training program, participants who successfully complete 8 hours of training will be offered a monetary reward as a token of appreciation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auditory Training Group
Arm Type
Experimental
Arm Description
12 hours of psychoacoustic training over 8 weeks
Arm Title
Other Training Group
Arm Type
Active Comparator
Arm Description
12 hours of non-psychoacoustic training over 8 weeks
Arm Title
TD Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Auditory Training
Intervention Description
A series of psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
Intervention Type
Behavioral
Intervention Name(s)
Non-auditory training
Intervention Description
A series of non-psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
Primary Outcome Measure Information:
Title
Change in Accuracy of Affective Prosody Recognition
Description
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.
Time Frame
Before & after 8-week intervention program
Title
Change in Ability in Discriminating Pitch Differences
Description
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.
Time Frame
Before & after 8-week intervention program
Title
Change in Accuracy in Processing Rapid Presentation of Two Tones
Description
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.
Time Frame
Before & after 8-week intervention program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cantonese as mother language IQ > 70 Children with autism spectrum disorder Exclusion Criteria: Children diagnosed with dyslexia Prior diagnosis of mental disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Lui, PhD
Organizational Affiliation
Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Learning Science
City
Kowloon Tong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymous individual participant data will be uploaded to an publicly accessible database should the results were published as a journal article.
IPD Sharing Time Frame
Data will be provided when a journal article is published for indefinite time
IPD Sharing Access Criteria
Access to the data will be made public. The link to the database will be provided in the journal article.
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Affective Prosody Recognition and Auditory Intervention for Children With Autism Spectrum Disorders (ASD)

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