Clinical trial NCT04427150: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
name: Education University of Hong Kong
First posted: 2020-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Accuracy of Affective Prosody Recognition
timeFrame: Before & after 8-week intervention program
measure: Change in Ability in Discriminating Pitch Differences
timeFrame: Before & after 8-week intervention program
measure: Change in Accuracy in Processing Rapid Presentation of Two Tones
timeFrame: Before & after 8-week intervention program
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Centre of Learning Science
Study officials:
affiliation: Hong Kong Baptist University
name: Ann M Lui, PhD
role: PRINCIPAL_INVESTIGATOR
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