Autism Spectrum DisorderNCT04427150
Affective Prosody Recognition and Auditory Intervention for Children With Autism Spectrum Disorders (ASD)
A study testing Auditory Training and Non-auditory training in people with Autism Spectrum Disorder, run by Hong Kong Baptist University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Auditory Training and Non-auditory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cantonese as mother language
- IQ > 70
- Children with autism spectrum disorder
Who cannot join
- Children diagnosed with dyslexia
- Prior diagnosis of mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Affective Prosody Recognition Among Children With Autism Spectrum Disorders and the Effectiveness of an Auditory Intervention Using a Mobile App
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Auditory Training, Non-auditory training
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory TrainingBehavioural
A series of psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
Non-auditory trainingBehavioural
A series of non-psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Auditory Training Group | Experimental | 12 hours of psychoacoustic training over 8 weeks Receives: Behavioral: Auditory Training |
| Other Training Group | Active comparator | 12 hours of non-psychoacoustic training over 8 weeks Receives: Behavioral: Non-auditory training |
| TD Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Before & after 8-week intervention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start25 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, Education University of Hong Kong
- Responsible party
- Principal investigator, Ming Lui, Hong Kong Baptist University
- Investigators
- Ann M Lui, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427150
- Sponsor's protocol ID
- HKBU 12604418
- Status last verified
- Mar 2022
- First submitted
- 1 Jun 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous individual participant data will be uploaded to an publicly accessible database should the results were published as a journal article.
Publications
Ashwin C, Baron-Cohen S, Wheelwright S, O'Riordan M, Bullmore ET. Differential activation of the amygdala and the 'social brain' during fearful face-processing in Asperger Syndrome. Neuropsychologia. 2007 Jan 7;45(1):2-14. doi: 10.1016/j.neuropsychologia.2006.04.014. Epub 2006 Jun 30.
PubMed 16806312Baron-Cohen S, Leslie AM, Frith U. Does the autistic child have a "theory of mind"? Cognition. 1985 Oct;21(1):37-46. doi: 10.1016/0010-0277(85)90022-8. No abstract available.
PubMed 2934210Bonnel A, Mottron L, Peretz I, Trudel M, Gallun E, Bonnel AM. Enhanced pitch sensitivity in individuals with autism: a signal detection analysis. J Cogn Neurosci. 2003 Feb 15;15(2):226-35. doi: 10.1162/089892903321208169.
PubMed 12676060Boucher J, Lewis V, Collis GM. Voice processing abilities in children with autism, children with specific language impairments, and young typically developing children. J Child Psychol Psychiatry. 2000 Oct;41(7):847-57.
PubMed 11079427Oram Cardy JE, Flagg EJ, Roberts W, Brian J, Roberts TP. Magnetoencephalography identifies rapid temporal processing deficit in autism and language impairment. Neuroreport. 2005 Mar 15;16(4):329-32. doi: 10.1097/00001756-200503150-00005.
PubMed 15729132Castelli F, Happe F, Frith U, Frith C. Movement and mind: a functional imaging study of perception and interpretation of complex intentional movement patterns. Neuroimage. 2000 Sep;12(3):314-25. doi: 10.1006/nimg.2000.0612.
PubMed 10944414Demopoulos C, Hopkins J, Kopald BE, Paulson K, Doyle L, Andrews WE, Lewine JD. Deficits in auditory processing contribute to impairments in vocal affect recognition in autism spectrum disorders: A MEG study. Neuropsychology. 2015 Nov;29(6):895-908. doi: 10.1037/neu0000209. Epub 2015 May 25.
PubMed 26011112Demopoulos C, Lewine JD. Audiometric Profiles in Autism Spectrum Disorders: Does Subclinical Hearing Loss Impact Communication? Autism Res. 2016 Jan;9(1):107-20. doi: 10.1002/aur.1495. Epub 2015 May 11.
PubMed 25962745Devine RT, Hughes C. Silent films and strange stories: theory of mind, gender, and social experiences in middle childhood. Child Dev. 2013 May-Jun;84(3):989-1003. doi: 10.1111/cdev.12017. Epub 2012 Nov 30.
PubMed 23199139Gaab N, Gabrieli JD, Deutsch GK, Tallal P, Temple E. Neural correlates of rapid auditory processing are disrupted in children with developmental dyslexia and ameliorated with training: an fMRI study. Restor Neurol Neurosci. 2007;25(3-4):295-310.
PubMed 17943007Gebauer L, Skewes J, Horlyck L, Vuust P. Atypical perception of affective prosody in Autism Spectrum Disorder. Neuroimage Clin. 2014 Oct 5;6:370-8. doi: 10.1016/j.nicl.2014.08.025. eCollection 2014.
PubMed 25379450Globerson E, Amir N, Kishon-Rabin L, Golan O. Prosody recognition in adults with high-functioning autism spectrum disorders: from psychoacoustics to cognition. Autism Res. 2015 Apr;8(2):153-63. doi: 10.1002/aur.1432. Epub 2014 Nov 26.
PubMed 25428545Golan O, Baron-Cohen S, Hill JJ, Golan Y. The "reading the mind in films" task: complex emotion recognition in adults with and without autism spectrum conditions. Soc Neurosci. 2006;1(2):111-23. doi: 10.1080/17470910600980986.
PubMed 18633780Grossman 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.
PubMed 22450703Hudepohl MB, Robins DL, King TZ, Henrich CC. The role of emotion perception in adaptive functioning of people with autism spectrum disorders. Autism. 2015 Jan;19(1):107-12. doi: 10.1177/1362361313512725. Epub 2013 Dec 11.
PubMed 24335115
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Affective Prosody Recognition Among Children With Autism Spectrum Disorders and the Effectiveness of an Auditory Intervention Using a Mobile App
- ClinicalTrials.gov ID
- NCT04427150
- Acronym / sponsor ID
- HKBU 12604418
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, Education University of Hong Kong
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Auditory Training Group | Experimental | Behavioral: Auditory Training12 hours of psychoacoustic training over 8 weeks |
| Other Training Group | Active comparator | Behavioral: Non-auditory training12 hours of non-psychoacoustic training over 8 weeks |
| TD Group | No intervention | – |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cantonese as mother language
- IQ > 70
- Children with autism spectrum disorder
Key exclusion criteria (2 listed)
- Children diagnosed with dyslexia
- Prior diagnosis of mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory TrainingA series of psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes | Behavioural | Auditory Training Group |
| Non-auditory trainingA series of non-psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes | Behavioural | Other Training Group |
Primary outcome
Change in Accuracy of Affective Prosody Recognition
Time frame: Before & after 8-week intervention program
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
Time frame: Before & after 8-week intervention program
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
Time frame: Before & after 8-week intervention program
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 16806312Ashwin C, Baron-Cohen S, Wheelwright S, O'Riordan M, Bullmore ET. Differential activation of the amygdala and the 'social brain' during fearful face-processing in Asperger Syndrome. Neuropsychologia. 2007 Jan 7;45(1):2-14. doi: 10.1016/j.neuropsychologia.2006.04.014. Epub 2006 Jun 30.
- Background: PubMed 2934210Baron-Cohen S, Leslie AM, Frith U. Does the autistic child have a "theory of mind"? Cognition. 1985 Oct;21(1):37-46. doi: 10.1016/0010-0277(85)90022-8. No abstract available.
- Background: PubMed 12676060Bonnel A, Mottron L, Peretz I, Trudel M, Gallun E, Bonnel AM. Enhanced pitch sensitivity in individuals with autism: a signal detection analysis. J Cogn Neurosci. 2003 Feb 15;15(2):226-35. doi: 10.1162/089892903321208169.
- Background: PubMed 11079427Boucher J, Lewis V, Collis GM. Voice processing abilities in children with autism, children with specific language impairments, and young typically developing children. J Child Psychol Psychiatry. 2000 Oct;41(7):847-57.
- Background: PubMed 15729132Oram Cardy JE, Flagg EJ, Roberts W, Brian J, Roberts TP. Magnetoencephalography identifies rapid temporal processing deficit in autism and language impairment. Neuroreport. 2005 Mar 15;16(4):329-32. doi: 10.1097/00001756-200503150-00005.
- Background: PubMed 10944414Castelli F, Happe F, Frith U, Frith C. Movement and mind: a functional imaging study of perception and interpretation of complex intentional movement patterns. Neuroimage. 2000 Sep;12(3):314-25. doi: 10.1006/nimg.2000.0612.
- Background: PubMed 26011112Demopoulos C, Hopkins J, Kopald BE, Paulson K, Doyle L, Andrews WE, Lewine JD. Deficits in auditory processing contribute to impairments in vocal affect recognition in autism spectrum disorders: A MEG study. Neuropsychology. 2015 Nov;29(6):895-908. doi: 10.1037/neu0000209. Epub 2015 May 25.
- Background: PubMed 25962745Demopoulos C, Lewine JD. Audiometric Profiles in Autism Spectrum Disorders: Does Subclinical Hearing Loss Impact Communication? Autism Res. 2016 Jan;9(1):107-20. doi: 10.1002/aur.1495. Epub 2015 May 11.
- Background: PubMed 23199139Devine RT, Hughes C. Silent films and strange stories: theory of mind, gender, and social experiences in middle childhood. Child Dev. 2013 May-Jun;84(3):989-1003. doi: 10.1111/cdev.12017. Epub 2012 Nov 30.
- Background: PubMed 17943007Gaab N, Gabrieli JD, Deutsch GK, Tallal P, Temple E. Neural correlates of rapid auditory processing are disrupted in children with developmental dyslexia and ameliorated with training: an fMRI study. Restor Neurol Neurosci. 2007;25(3-4):295-310.
- Background: PubMed 25379450Gebauer L, Skewes J, Horlyck L, Vuust P. Atypical perception of affective prosody in Autism Spectrum Disorder. Neuroimage Clin. 2014 Oct 5;6:370-8. doi: 10.1016/j.nicl.2014.08.025. eCollection 2014.
- Background: PubMed 25428545Globerson E, Amir N, Kishon-Rabin L, Golan O. Prosody recognition in adults with high-functioning autism spectrum disorders: from psychoacoustics to cognition. Autism Res. 2015 Apr;8(2):153-63. doi: 10.1002/aur.1432. Epub 2014 Nov 26.
- Individual participant dataSharing planned: Yes. Anonymous individual participant data will be uploaded to an publicly accessible database should the results were published as a journal article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Lui, PhD principal investigator
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Training and Non-auditory training in people with Autism Spectrum Disorder, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Accuracy of Affective Prosody Recognition (time frame: Before & after 8-week intervention program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427150, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.