Autism Spectrum Disorder High-FunctioningPhase 1NCT06421272
APP-based Emotion Recognition Training Improve ASD Social Function
A Phase 1 study testing APP-based emotion recognition intervention and APP-based memory intervention in people with Autism Spectrum Disorder High-Functioning, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder High-Functioning
- What is being tested?
- APP-based emotion recognition intervention and APP-based memory intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 May 2024
- Phase
- Phase 1
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Inclusion criteria: Clinical diagnosis of Autism Spectrum Disorder and follow these criteria: (1) Age range: 4-10 years old, gender not limited;(2) Ethnicity: Han nationality;(3) Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Comparison Score greater than or equal to 5 points (Le et al., 2022);(4) Considering that only high-functioning autism individuals can successfully complete the eye-tracking tasks, children with a Wechsler score greater than or equal to 60 points are selected; Exclusion criteria: (1) No neurological complications, such as epilepsy, cerebral palsy, fragile X syndrome, etc.;(2) No prior medical interventions, such as taking antipsychotic drugs, receiving transcranial magnetic stimulation, acupuncture, etc.;(3) No abnormal imaging diagnosis or any brain injury.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology
Chengdu, Sichuan, 611731
Weihua Zhao, Phd, +86 18780247797, zarazhao@uestc.edu.cn
About this study
The main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children.
Read the detailed description
50 ASD children age ranged from 4-10 years old will be randomly allocated to either app-based emotional recognition training or memory training groups for 2 months. Before and after training, some assessements were measured including Autism Diagnostic Observation Schedule-2, Childhood Autism Rating Scale, Wechsler Intelligence Scale and Psychoeducational Profile-3. Some other questionnaires are also collected including Social Responsibility Scale-2,Repetitive behavior scale-Revised,Caregiver Strains Questionnaire，Social Communication Questionnaire，Social Anxiety Scale for Children，Adaptive behavior assessment Schedule. Four eye-tracking tasks as follows: (1) Dynamic geometrical paired with dynamic child dancing; (2) Static neutral and emotional faces; (3) A dynamic gaze-following task; (4) social interaction behaviors paired with the toys alone; (5) spinning actions conducted via children paired with objects.
- Being tested
- APP-based emotion recognition intervention, APP-based memory intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP-based emotion recognition interventionBehavioural
ASD children were asked to play emotion recognition-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.
APP-based memory interventionBehavioural
ASD children were asked to play memory-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.
| Study group | Role | What they receive |
|---|---|---|
| APP-based emotion recognition trainning | Experimental | Experimental group: ASD children were asked to do emotion recognition for eight weeks using iPAD. Two 15-minsute sessions each day was required. Receives: Behavioral: APP-based emotion recognition intervention |
| APP-based memory training | Active comparator | Control group: ASD children were asked to do memory training (i.e. 1 back) for eight weeks using iPAD. Two 15-minsute sessions each day was required. Receives: Behavioral: APP-based memory intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADOS-2 assessment
ADOS-2 assessment
Measured: 1-2 hour
SRS-2
SRS-2
Measured: half an hour
Secondary outcomes (1)
Visual performance across five tasks based on eye-tracking
Tasked based eye-tracking performance including fixation time, fixation counts
Measured: half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder High-FunctioningStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group (emotion recognition); control group (memory training)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Zhao, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421272
- Sponsor's protocol ID
- UESTC-neuSCAN-94
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APP-based Emotion Recognition Training Improve ASD Social Function
- ClinicalTrials.gov ID
- NCT06421272
- Acronym / sponsor ID
- UESTC-neuSCAN-94
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 20 May 2024 (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 main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children.
Detailed description
50 ASD children age ranged from 4-10 years old will be randomly allocated to either app-based emotional recognition training or memory training groups for 2 months. Before and after training, some assessements were measured including Autism Diagnostic Observation Schedule-2, Childhood Autism Rating Scale, Wechsler Intelligence Scale and Psychoeducational Profile-3. Some other questionnaires are also collected including Social Responsibility Scale-2,Repetitive behavior scale-Revised,Caregiver Strains Questionnaire，Social Communication Questionnaire，Social Anxiety Scale for Children，Adaptive behavior assessment Schedule. Four eye-tracking tasks as follows: (1) Dynamic geometrical paired with dynamic child dancing; (2) Static neutral and emotional faces; (3) A dynamic gaze-following task; (4) social interaction behaviors paired with the toys alone; (5) spinning actions conducted via children paired with objects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group (emotion recognition); control group (memory training)
| Arm | Type | Receives |
|---|---|---|
| APP-based emotion recognition trainning | Experimental | Behavioral: APP-based emotion recognition interventionExperimental group: ASD children were asked to do emotion recognition for eight weeks using iPAD. Two 15-minsute sessions each day was required. |
| APP-based memory training | Active comparator | Behavioral: APP-based memory interventionControl group: ASD children were asked to do memory training (i.e. 1 back) for eight weeks using iPAD. Two 15-minsute sessions each day was required. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| APP-based emotion recognition interventionASD children were asked to play emotion recognition-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required. | Behavioural | APP-based emotion recognition trainning |
| APP-based memory interventionASD children were asked to play memory-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required. | Behavioural | APP-based memory training |
Primary outcome
ADOS-2 assessment
Time frame: 1-2 hour
ADOS-2 assessment
SRS-2
Time frame: half an hour
SRS-2
1 secondary outcome
Visual performance across five tasks based on eye-tracking
Time frame: half an hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APP-based emotion recognition intervention and APP-based memory intervention in people with Autism Spectrum Disorder High-Functioning, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 20 May 2024. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADOS-2 assessment (time frame: 1-2 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2024.