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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04427150
Other study ID # HKBU 12604418
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2020
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source Hong Kong Baptist University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria: - Cantonese as mother language - IQ > 70 - Children with autism spectrum disorder Exclusion Criteria: - Children diagnosed with dyslexia - Prior diagnosis of mental disorders

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hong Kong Centre of Learning Science Kowloon Tong

Sponsors (3)

Lead Sponsor Collaborator
Hong Kong Baptist University Education University of Hong Kong, The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (33)

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* Note: There are 33 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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