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Autism Spectrum DisorderNCT07308210

Hybrid Computerized EF Training Using Virtual Human Stimuli for Autism

A study testing Hybrid computerized executive function training in people with Autism Spectrum Disorder, run by Education University of Hong Kong at 1 site in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this pilot clinical trial is to learn the preliminary feasibility and efficacy of a home-based hybrid computerized executive function (EF) training program using social stimuli for autistic individuals. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 8 to 17 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Hybrid computerized executive function training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteHong Kong
Study dates
2 May 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Having met the DSM-V-TR criteria for autism spectrum disorder
  • Age between 8 and 17 years
  • Normal or corrected-to-normal vision

Who cannot join

  • Any neurological conditions
  • Head injuries requiring hospitalization

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • The Education University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Developing a Home-based Executive Function Training Program for Autistic Individuals

The goal of this pilot clinical trial is to learn the preliminary feasibility and efficacy of a home-based hybrid computerized executive function (EF) training program using social stimuli for autistic individuals. The main questions it aims to answer are:

  1. Does hybrid EF training using virtual human stimuli improve the EF and symptoms of autistic individuals?
  2. What are the parents' attitudes toward the training program?
Read more

Researchers will compare changes in EF task performance and parent-report autistic symptoms and investigate parents' responses on a feedback questionnaire after autistic individuals undergo two weeks of training.

Participants will:

  1. Undergo computerized training at home five 30-minute sessions a week, for two weeks
  2. Visit the university campus before and after the training program to undertake an assessment
Read the detailed description

To facilitate the integration of executive functioning (EF) and socio-emotional cue processing, we developed a novel home-based EF training program utilizing virtual, culturally relevant human facial stimuli for autistic individuals. We will ask autistic participants aged 8-17 to engage in training using this newly developed application at home over a two-week period, with five 30-minute sessions per week.

The newly developed hybrid computerized training application features three games targeting the three core components of executive function (EF): shifting, inhibition, and updating (Miyake et al., 2000). These games utilize 20 virtual Asian characters generated with Character Creator 4 (Reallusion Inc.).

The Face-Judgment Game (Categorization or "分門別類") trains shifting and mental flexibility by involving sex and emotion judgments (de Vries \& Geurts, 2012). Each round has 33 trials. Trials begin with a blank period, followed by a cue period lasting between 2000 ms and a decreasing duration from 1000 ms to 200 ms as difficulty increases. The cue is either "Sex" or "Emotion." After these periods, a face displaying happiness or fear is shown at the center of the screen. The player judges the face's sex (male/female) or emotion (happy/scared) based on the cue, responding as quickly and accurately as possible. Trials are either repeat trials (same judgment as previous) or switch trials (different judgment). Performance indices include mean switch reaction time (RT) and switch cost RT, used for difficulty adjustment.

The Gaze-Arrow Game (Point Out The Way or "指點迷津") trains inhibition and interference control by requiring processing gaze direction amid distractors (Eriksen \& Eriksen, 1974). Each round has 32 trials. Trials start with a blank period, then present a neutral or emotional face along with arrow flankers pointing left or right. The number of arrow pairs increases from one to five across levels, creating greater interference when target and flanker directions mismatch (Chanceaux et al., 2014). The player judges gaze direction. Trials are either congruent (gaze and arrows same direction) or incongruent (opposite directions). Performance is measured by the mean incongruent RT and the RT difference between incongruent and congruent trials (interference score), used for level adjustment.

The Running Memory Game (Character Memorization or "人物記憶") trains updating working memory by processing face identities (Morris \& Jones, 1990). Each trial begins with an instruction cue, followed by a sequence of neutral or emotional faces. The cue prompts the player to remember a face from n trials earlier, with n increasing from 1 to 5 to impose greater working memory demands. The sequence length varies randomly from 6 to 10 faces, with no repeated identities. After the sequence, five recent faces are shown, and the player selects the face matching the cue. Accuracy serves as the performance index for level adjustment.

Assessments of participants' EF and clinical symptoms will be conducted within one week before the first training session and within one week after the last training session. Additionally, we will examine parents' attitudes toward the program.

The go/no-go task measures inhibition (Picton et al., 2007). It requires participants to press a button in response to one letter (go trials) and to withhold responses to other letters (no-go trials). Each trial consists of a letter appearing for 300 ms, followed by an interstimulus interval of 1,000 to 1,400 ms (mean = 1,200 ms). The go:no-go ratio is 3:1, with 240 go trials and 80 no-go trials. The false alarm rate is analyzed.

The Sternberg working memory task assesses the storage and retrieval of items from short-item memory (Sternberg, 1966). It requires participants to remember sets of 3 or 6 capital English letters, one by one. The two set sizes are equiprobable and presented in a randomized order. On each trial, participants see a fixation cross for 500 ms, followed by the letter stimuli presented for 2,000 ms. This is followed by a 3,000-ms blank period, then a lowercase letter probe appears for 1,000 ms, followed by an interstimulus interval of 1,750 to 2,250 ms (mean = 2,000 ms). The response time window is 2,750 ms. There are28 trials for each set size. Accuracy at set size 6 is analyzed.

The digit task-switching task measures shifting (Monsell, 2003). On each trial, a fixation cross is shown for 500 ms. Next, a cue indicating either "large/small" (magnitude judgment) or "odd/even" (parity judgment) is presented either at 0 ms or 1,000 ms before a single digit, ranging from 1 to 9 (excluding 5). Upon seeing the digit, participants are required to judge the digit according to the cue as fast as possible via a button press. A repeat trial occurs when the current judgment is the same as the previous one, and a switch trial is defined when the present judgment differed from the last one. These two trial types and the two cue-target intervals are equiprobable, with 32 trials for each combination. The reaction time (RT) switch cost (i.e., difference in mean RT between repeat and switch trials) at 0-ms cue-target interval, which allows no preparation, is analyzed.

The Social Responsiveness Scale-2 (SRS-2) has 65 items measuring the social function deficits associated with autism (e.g., "has difficulty relating to peers") (Constantino \& Gruber, 2012). Each item is rated on a 4-point scale from "0" (never true) to "3" (almost always true). The questionnaire yields two DSM-V compatible subscale scores, including the Social Communication and Interaction (SCI) and Restricted Interests and Repetitive Behavior (RRB) scores. The raw scores of these two subscales are analyzed.

A feedback questionnaire is completed by parents to evaluate their attitudes toward the training program and to collect suggestions for game improvement. They rate six items on a 7-point Likert scale, from -3 to +3. These items include 'interestingness of the training games' (from very boring to very interesting), 'difficulty of the training games' (from too easy to too difficult), 'duration of the training games' (from too short to too long), 'perceived change in the child following training' (from very negative to very positive), 'satisfaction with the overall arrangement of the training' (from very dissatisfied to very satisfied), 'willingness to have the child join similar cognitive training in the future' (from very unwilling to very willing).

We hypothesize that both EF and clinical symptoms will improve due to enhanced integration of EF and social-cognitive processes. The hypothesis will be confirmed by conducting t-tests on the outcome measures.

Being tested
Hybrid computerized executive function 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.

  • Hybrid computerized executive function trainingBehavioural

    The Face-Judgment game trains shifting through 33 trials where players judge a face's sex or emotion based on cues. Trials include repeat or switch judgments, with cue durations decrease from 1,000 ms to 200 ms to increase difficulty. Performance metrics include mean switch RT and switch cost RT for adjusting difficulty. The Gaze-Arrow game enhances inhibition by requiring players to process gaze direction amidst distractors. Each round has 32 trials with faces and arrows pointing left or right. Arrow pairs increase from 1 to 5 across levels, increasing interference in incongruent trials, where gaze and arrow directions mismatch. Players judge gaze direction; performance is measured by mean incongruent RT and interference score. The Running Memory game trains working memory by having players recall face identities from n trials earlier, with n increasing from 1 to 5. Afterward, players select the face matching the cue from five options, with accuracy guiding level adjustments.

Study groups in NCT07308210
Study groupRoleWhat they receive
Hybrid computerized executive function trainingExperimentalHybrid computerized executive function training five 30-minute sessions a week, for two weeks.
Receives: Behavioral: Hybrid computerized executive function training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Go/No-Go Task - The false alarm rate

    The percentage of false alarms made on no-go trials

    Measured: Within one week before the first training session and within one week after the last training session

  2. The Sternberg Working Memory Task - Accuracy at set size 6

    The percentage of probes recognized when arrays of 6 letters are to be remembered

    Measured: Within one week before the first training session and within one week after the last training session

  3. The Digit Task-Switching Task - Reaction time (RT) switch cost

    Difference in mean RT between repeat and switch trials

    Measured: Within one week before the first training session and within one week after the last training session

  4. The Social Responsiveness Scale-2 (SRS-2) - Social Communication and Interaction (SCI) raw score

    A parent-reported measure of social functioning deficits associated with autism

    Measured: Within one week before the first training session and within one week after the last training session

  5. The Social Responsiveness Scale-2 (SRS-2) - Restricted Interests and Repetitive Behavior (RRB) raw score

    A parent-reported measure of behavioral inflexibility associated with autism

    Measured: Within one week before the first training session and within one week after the last training session

  6. Parents' Feedback Questionnaire - Score

    Parents' attitudes toward various statements regarding the training program, rated on a 7-point Likert scale (from -3 to +3)

    Measured: Within one week after the last training session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start2 May 2024
  3. Primary completion27 Aug 2024
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07308210
Sponsor's protocol ID
2022-2023-0504
Status last verified
Dec 2025
First submitted
15 Dec 2025
Last updated
29 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chanceaux M, Mathot S, Grainger J. Effects of number, complexity, and familiarity of flankers on crowded letter identification. J Vis. 2014 Nov 10;14(6):7. doi: 10.1167/14.6.7.

    PubMed 25384390
  • de Vries M, Geurts HM. Cognitive flexibility in ASD; task switching with emotional faces. J Autism Dev Disord. 2012 Dec;42(12):2558-68. doi: 10.1007/s10803-012-1512-1.

    PubMed 22456815
  • Eriksen, B. A., & Eriksen, C. W. (1974). Effects of noise letters upon the identification of a target letter in a nonsearch task. Perception & psychophysics, 16(1), 143-149. https://doi.org/10.3758/BF03203267

  • Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.

    PubMed 10945922
  • Morris, N., & Jones, D. M. (1990). Memory updating in working memory: The role of the central executive. British journal of psychology, 81(2), 111-121. https://doi.org/10.1111/j.2044-8295.1990.tb02349.x

  • Constantino, J. N., & Gruber, C. P. (2012). Social responsiveness scale, Second Edition (SRS-2). Torrance, CA: Western Psychological Services.

  • Monsell S. Task switching. Trends Cogn Sci. 2003 Mar;7(3):134-140. doi: 10.1016/s1364-6613(03)00028-7.

    PubMed 12639695
  • Picton TW, Stuss DT, Alexander MP, Shallice T, Binns MA, Gillingham S. Effects of focal frontal lesions on response inhibition. Cereb Cortex. 2007 Apr;17(4):826-38. doi: 10.1093/cercor/bhk031. Epub 2006 May 12.

    PubMed 16699079
  • Sternberg S. High-speed scanning in human memory. Science. 1966 Aug 5;153(3736):652-4. doi: 10.1126/science.153.3736.652.

    PubMed 5939936

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid computerized executive function training in people with Autism Spectrum Disorder, run by Education University of Hong Kong 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: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

The Go/No-Go Task - The false alarm rate (time frame: Within one week before the first training session and within one week after the last training session). The study lists 6 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 NCT07308210, which also lists 9 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 29 Dec 2025.

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