NCT07308210

Brief 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. 1.Does hybrid EF training using virtual human stimuli improve the EF and symptoms of autistic individuals?
  2. 2.What are the parents' attitudes toward the training program?
  3. 3.Undergo computerized training at home five 30-minute sessions a week, for two weeks
  4. 4.Visit the university campus before and after the training program to undertake an assessment

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
May 2024Dec 2027

Study Start

First participant enrolled

May 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Go/No-Go Task - The false alarm rate

    The percentage of false alarms made on no-go trials

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

  • The Sternberg Working Memory Task - Accuracy at set size 6

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

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

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

    Difference in mean RT between repeat and switch trials

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

  • 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

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

  • 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

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

  • Parents' Feedback Questionnaire - Score

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

    Within one week after the last training session

Study Arms (1)

Hybrid computerized executive function training

EXPERIMENTAL

Hybrid computerized executive function training five 30-minute sessions a week, for two weeks.

Behavioral: Hybrid computerized executive function training

Interventions

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.

Hybrid computerized executive function training

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Any neurological conditions
  • Head injuries requiring hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (9)

  • 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.

    PMID: 25384390BACKGROUND
  • 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.

    PMID: 22456815BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 10945922BACKGROUND
  • 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

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

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

    PMID: 12639695BACKGROUND
  • 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.

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

    PMID: 5939936BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Michael Yeung, PhD

    The Education University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 29, 2025

Study Start

May 2, 2024

Primary Completion

August 27, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations