<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427150</url>
  </required_header>
  <id_info>
    <org_study_id>HKBU 12604418</org_study_id>
    <nct_id>NCT04427150</nct_id>
  </id_info>
  <brief_title>Affective Prosody Recognition and Auditory Intervention for Children With Autism Spectrum Disorders (ASD)</brief_title>
  <official_title>Examining Affective Prosody Recognition Among Children With Autism Spectrum Disorders and the Effectiveness of an Auditory Intervention Using a Mobile App</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Baptist University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Education University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hong Kong Baptist University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study aims to examine the abilities of children with ASD to recognize emotional&#xD;
      tones of voice - also known as affective prosody - as compared to typically developing (TD)&#xD;
      children. Past findings are mixed, and although some studies have found intact performance&#xD;
      among individuals with ASD, it is possible that they rely on different underlying mechanisms&#xD;
      in processing affective prosody compared to TD children. Our second objective is therefore to&#xD;
      examine whether children with ASD have a stronger reliance on psychoacoustic abilities -&#xD;
      including rapid auditory processing and pitch direction recognition - to identify emotional&#xD;
      stimuli, as compared to TD children. Lastly, the investigators will study whether auditory&#xD;
      training targeting psychoacoustic abilities would improve affective prosody recognition among&#xD;
      children with ASD. Sixty children with ASD and 60 TD children between 10 to 12 years old will&#xD;
      be recruited. Participants' psychoacoustic abilities and affective prosody recognition will&#xD;
      be assessed in the pretest. The investigators hypothesize that psychoacoustic abilities are&#xD;
      stronger predictors of affective prosody recognition among children with ASD than among TD&#xD;
      children. The ASD children will then be randomly assigned to two groups: one group will&#xD;
      receive auditory training; the other will be an active control group that receives&#xD;
      non-auditory training. Both groups will receive 12 hours of training via a mobile app. The&#xD;
      children will be assessed again in the posttest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will sign an informed consent statement prior to arriving at the lab.&#xD;
      Participants with ASD will be randomly assigned into either the auditory training group&#xD;
      (Group 1) or the active control group (Group 2). Participants without ASD will be assigned to&#xD;
      the typically developed group (Group 3). Groups 1 and 2 will complete all stages of the&#xD;
      study, whereas Group 3 will only complete the pre-test stage.&#xD;
&#xD;
      Pre-test: Researchers will assess participants' affective prosody recognition ability and&#xD;
      psychoacoustic ability. The tests will be conducted in a sound attenuated lab located at Hong&#xD;
      Kong Baptist University. The tests include an affective prosody recognition test, a pitch&#xD;
      discrimination recognition test, a rapid auditory processing test, and a theory of mind test.&#xD;
&#xD;
      Intervention Training: Participants will be required to partake in an intervention training&#xD;
      program. The program will adopt training exercises provided by Posit Science - BrainHQ. The&#xD;
      participants will be asked to complete a training session of 15-30 minutes each day for 8&#xD;
      weeks, arriving at a total of at least 8 hours of training. The progress of intervention&#xD;
      training will be closely monitored by the research team.&#xD;
&#xD;
      Post-test: Participant will be asked to return to the lab for post-test assessment of the&#xD;
      same tests, and complete an autism assessment (ADOS-2) and intelligence assessment (WISC-IV)&#xD;
      conducted by a clinical psychologist, as well as a non-verbal Intelligence test (KBIT-2)&#xD;
      conducted by a trained researcher.&#xD;
&#xD;
      Note: For ethical and fairness purposes, participants from Group 2 will be allowed to access&#xD;
      the intervention training after Post-test.&#xD;
&#xD;
      To encourage completion of the intervention training program, participants who successfully&#xD;
      complete 8 hours of training will be offered a monetary reward as a token of appreciation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Accuracy of Affective Prosody Recognition</measure>
    <time_frame>Before &amp; after 8-week intervention program</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Ability in Discriminating Pitch Differences</measure>
    <time_frame>Before &amp; after 8-week intervention program</time_frame>
    <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 &quot;two-down one-up&quot; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Accuracy in Processing Rapid Presentation of Two Tones</measure>
    <time_frame>Before &amp; after 8-week intervention program</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Auditory Training Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 hours of psychoacoustic training over 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other Training Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 hours of non-psychoacoustic training over 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TD Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Auditory Training</intervention_name>
    <description>A series of psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes</description>
    <arm_group_label>Auditory Training Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-auditory training</intervention_name>
    <description>A series of non-psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes</description>
    <arm_group_label>Other Training Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cantonese as mother language&#xD;
&#xD;
          -  IQ &gt; 70&#xD;
&#xD;
          -  Children with autism spectrum disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children diagnosed with dyslexia&#xD;
&#xD;
          -  Prior diagnosis of mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann M Lui, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Baptist University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre of Learning Science</name>
      <address>
        <city>Kowloon Tong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
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  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Baptist University</investigator_affiliation>
    <investigator_full_name>Ming Lui</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymous individual participant data will be uploaded to an publicly accessible database should the results were published as a journal article.</ipd_description>
    <ipd_time_frame>Data will be provided when a journal article is published for indefinite time</ipd_time_frame>
    <ipd_access_criteria>Access to the data will be made public. The link to the database will be provided in the journal article.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427150
org study id: HKBU 12604418
nct id: NCT04427150
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Change in Accuracy of Affective Prosody Recognition
time frame: Before & after 8-week intervention program
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.
measure: Change in Ability in Discriminating Pitch Differences
time frame: Before & after 8-week intervention program
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.
measure: Change in Accuracy in Processing Rapid Presentation of Two Tones
time frame: Before & after 8-week intervention program
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.
arm group label: Auditory Training Group
arm group type: Experimental
description: 12 hours of psychoacoustic training over 8 weeks
arm group label: Other Training Group
arm group type: Active Comparator
description: 12 hours of non-psychoacoustic training over 8 weeks
arm group label: TD Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Auditory Training
description: A series of psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
arm group label: Auditory Training Group
intervention type: Behavioral
intervention name: Non-auditory training
description: A series of non-psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
arm group label: Other Training Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ann M Lui, PhD
role: Principal Investigator
affiliation: Hong Kong Baptist University
facility: 
country: Hong Kong
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responsible party type: Principal Investigator
investigator affiliation: Hong Kong Baptist University
investigator full name: Ming Lui
investigator title: Associate Professor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: Yes
ipd description: Anonymous individual participant data will be uploaded to an publicly accessible database should the results were published as a journal article.
ipd time frame: Data will be provided when a journal article is published for indefinite time
ipd access criteria: Access to the data will be made public. The link to the database will be provided in the journal article.