Autism Spectrum DisorderNCT07801833
Executive Function Training Program for Children With ASD
A study testing Executive Function Training Program in people with Autism Spectrum Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn whether a structured executive function training program can improve executive function, adaptive behavior, and self-regulation in elementary school students with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Executive Function Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Mar 2026to Jan 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 9 to 12 years who are attending elementary school
- Diagnosis of autism spectrum disorder (ASD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Full-scale intelligence quotient (IQ) of 70 or higher
- Ability to understand the study procedures and participate in the intervention program
- Availability of a parent or legal guardian who is able to participate in the parent sessions and study assessments
Who cannot join
- Presence of a severe neurological or medical condition that may interfere with participation in the study
- Presence of a severe psychiatric or behavioral condition that may interfere with participation in the group-based intervention
- Significant sensory or physical impairment that would prevent participation in the intervention or assessments
- Concurrent participation in another structured intervention program targeting executive function during the study period
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: A Randomized Controlled Trial for the Development and Validation of an Executive Function Training Program for Elementary School Students
The goal of this clinical trial is to learn whether a structured executive function training program can improve executive function, adaptive behavior, and self-regulation in elementary school students with autism spectrum disorder (ASD). The main questions it aims to answer are:
Does the program improve participants' executive function skills and their ability to use these skills in daily life? Does the program improve participants' adaptive behavior and self-regulation?
Read more
Researchers will compare participants who receive the executive function training program with participants in a waitlist control group to determine whether the program is effective.
Participants will be randomly assigned to either the intervention group or the waitlist control group and will complete assessments before and after the intervention. The intervention consists of a structured, group-based program provided once a week for 12 weeks. Children participate in sessions designed to teach and practice executive function strategies, while their parents participate in parent education and review of home practice to support the use of these skills in daily life.
The program focuses on skills such as planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. Participants practice applying these strategies to situations encountered at home, at school, and in everyday life.
Read the detailed description
Executive function refers to a set of skills that support goal-directed behavior and independent functioning, including planning, organization, task initiation, time management, emotional and impulse control, flexible thinking, working memory, and self-monitoring. Difficulties in executive function may affect how children with autism spectrum disorder (ASD) manage everyday demands at home, at school, and in social situations. These difficulties may also be related to adaptive functioning and self-regulation.
This study evaluates a structured executive function training program developed for elementary school students with ASD. The program is designed to help children understand executive function strategies, practice them in structured activities, and apply them to situations encountered in everyday life. Rather than focusing only on performance on cognitive tasks, the intervention emphasizes the practical use of executive function skills for daily activities, school routines, emotional and behavioral regulation, and interactions with others.
The program is delivered in a group format over 12 weekly sessions. Intervention sessions use explicit instruction, therapist modeling, guided practice, role-play and other activities, feedback, and home practice. The major areas addressed include planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. Visual materials and age-appropriate activities are used to help children understand and practice the strategies.
Parents participate in a parallel parent component. They review the skills taught to their children, receive guidance on supporting the use of these strategies, and review the child's home practice with the intervention team. Parent involvement is intended to promote generalization of skills learned during the sessions to everyday settings.
Participants are randomly assigned to an intervention group or a waitlist control group. After the initial intervention period and post-intervention assessment, participants in the waitlist control group are also offered the program. The study examines whether participation in the program is associated with improvement in executive function and its use in daily life, as well as adaptive behavior, self-regulation, and related psychosocial functioning.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Executive Function Training Program
- Keywords
- Executive Function, Executive Function Training, Adaptive Behavior, Self-Regulation, Parent-Mediated Intervention
- Medical subject headings
- Autism Spectrum Disorder, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive Function Training ProgramBehavioural
A 12-week, structured, group-based executive function training program delivered once weekly to elementary school students aged 9-12 years with autism spectrum disorder (ASD) and their parents. Each weekly session includes an 80-minute child session and a 65-minute parent session. The child sessions use explicit instruction, modeling, guided practice, role-play, feedback, and home practice to teach and practice executive function strategies related to planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. In parallel, parents receive education on the same executive function topics taught to their children and review their child's home practice. Parent involvement is designed to help children apply and generalize the executive function strategies learned in the program to daily life at home, at school, and in other everyday situations.
| Study group | Role | What they receive |
|---|---|---|
| Executive Function Training Group | Experimental | Participants receive a structured, group-based executive function training program once a week for 12 weeks. The program includes an 80-minute child session and a 65-minute parent session each week. Parents receive education on the same executive function topics taught to their children and review home practice to support the application and generalization of these skills in daily life. Receives: Behavioral: Executive Function Training Program |
| Waitlist Control Group | No intervention | Participants do not receive the executive function training program during the initial 12-week intervention period. After completion of the post-intervention assessment, participants in the waitlist control group are offered the same executive function training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
The BRIEF-2 is a parent-report questionnaire that assesses executive function behaviors in children's everyday life. The Global Executive Composite (GEC), index scores, and individual clinical scale scores will be analyzed to evaluate changes in different aspects of executive functioning. Higher T-scores indicate greater difficulties with executive functioning, whereas lower T-scores indicate fewer difficulties.
Measured: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Secondary outcomes (4)
Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
The Vineland-3 is a standardized measure of adaptive functioning in everyday life. The Adaptive Behavior Composite (ABC) score will be used as the primary outcome measure. Domain scores for Communication, Daily Living Skills, and Socialization will also be analyzed. Higher scores indicate better adaptive functioning.
Measured: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Emotion Regulation as Assessed by the Emotion Regulation Checklist (ERC)
The Emotion Regulation Checklist (ERC) is a 24-item questionnaire that assesses children's emotional regulation and emotional lability/negativity. Items are rated on a 4-point scale from 1 (Never) to 4 (Always). Scores for the Emotion Regulation and Lability/Negativity subscales will be analyzed, with higher Emotion Regulation scores indicating better emotion regulation and higher Lability/Negativity scores indicating greater emotional dysregulation.
Measured: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Academic Self-Regulation as Assessed by the Academic Self-Regulation Questionnaire (SRQ-A)
The Academic Self-Regulation Questionnaire (SRQ-A) is a child-report measure that assesses children's reasons for engaging in school-related behaviors. It includes four regulatory styles: external regulation, introjected regulation, identified regulation, and intrinsic motivation. Items are rated on a 4-point scale, with higher subscale scores indicating greater endorsement of the corresponding regulatory style. Subscale scores and the Relative Autonomy Index (RAI) will be analyzed, with higher RAI scores indicating more autonomous or self-determined regulation.
Measured: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Prosocial Self-Regulation as Assessed by the Prosocial Self-Regulation Questionnaire (SRQ-P)
The Prosocial Self-Regulation Questionnaire (SRQ-P) is a child-report measure that assesses children's reasons for engaging in prosocial behaviors. It includes three regulatory styles: external regulation, introjected regulation, and identified regulation. Items are rated on a 4-point scale, with higher subscale scores indicating greater endorsement of the corresponding regulatory style. Subscale scores will be analyzed to assess changes in the regulation of prosocial behavior.
Measured: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start12 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Jeong Yoo, MD., Ph.D., Principal investigator, Seoul National University College of Medicine, Child and Adolescent Psychiatry Clinic Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801833
- Sponsor's protocol ID
- B-2512-1015-001
- Status last verified
- Apr 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for the Development and Validation of an Executive Function Training Program for Elementary School Students
- ClinicalTrials.gov ID
- NCT07801833
- Acronym / sponsor ID
- B-2512-1015-001
- Conditions
- Autism Spectrum Disorder
- Keywords
- Executive Function, Executive Function Training, Adaptive Behavior, Self-Regulation, Parent-Mediated Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Sep 2026 (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 goal of this clinical trial is to learn whether a structured executive function training program can improve executive function, adaptive behavior, and self-regulation in elementary school students with autism spectrum disorder (ASD). The main questions it aims to answer are:
Does the program improve participants' executive function skills and their ability to use these skills in daily life? Does the program improve participants' adaptive behavior and self-regulation?
Researchers will compare participants who receive the executive function training program with participants in a waitlist control group to determine whether the program is effective.
Participants will be randomly assigned to either the intervention group or the waitlist control group and will complete assessments before and after the intervention. The intervention consists of a structured, group-based program provided once a week for 12 weeks. Children participate in sessions designed to teach and practice executive function strategies, while their parents participate in parent education and review of home practice to support the use of these skills in daily life.
The program focuses on skills such as planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. Participants practice applying these strategies to situations encountered at home, at school, and in everyday life.
Detailed description
Executive function refers to a set of skills that support goal-directed behavior and independent functioning, including planning, organization, task initiation, time management, emotional and impulse control, flexible thinking, working memory, and self-monitoring. Difficulties in executive function may affect how children with autism spectrum disorder (ASD) manage everyday demands at home, at school, and in social situations. These difficulties may also be related to adaptive functioning and self-regulation.
This study evaluates a structured executive function training program developed for elementary school students with ASD. The program is designed to help children understand executive function strategies, practice them in structured activities, and apply them to situations encountered in everyday life. Rather than focusing only on performance on cognitive tasks, the intervention emphasizes the practical use of executive function skills for daily activities, school routines, emotional and behavioral regulation, and interactions with others.
The program is delivered in a group format over 12 weekly sessions. Intervention sessions use explicit instruction, therapist modeling, guided practice, role-play and other activities, feedback, and home practice. The major areas addressed include planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. Visual materials and age-appropriate activities are used to help children understand and practice the strategies.
Parents participate in a parallel parent component. They review the skills taught to their children, receive guidance on supporting the use of these strategies, and review the child's home practice with the intervention team. Parent involvement is intended to promote generalization of skills learned during the sessions to everyday settings.
Participants are randomly assigned to an intervention group or a waitlist control group. After the initial intervention period and post-intervention assessment, participants in the waitlist control group are also offered the program. The study examines whether participation in the program is associated with improvement in executive function and its use in daily life, as well as adaptive behavior, self-regulation, and related psychosocial functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive Function Training Group | Experimental | Behavioral: Executive Function Training ProgramParticipants receive a structured, group-based executive function training program once a week for 12 weeks. The program includes an 80-minute child session and a 65-minute parent session each week. Parents receive education on the same executive function topics taught to their children and review home practice to support the application and generalization of these skills in daily life. |
| Waitlist Control Group | No intervention | –Participants do not receive the executive function training program during the initial 12-week intervention period. After completion of the post-intervention assessment, participants in the waitlist control group are offered the same executive function training program. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 9 to 12 years who are attending elementary school
- Diagnosis of autism spectrum disorder (ASD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Full-scale intelligence quotient (IQ) of 70 or higher
- Ability to understand the study procedures and participate in the intervention program
- Availability of a parent or legal guardian who is able to participate in the parent sessions and study assessments
Key exclusion criteria (4 listed)
- Presence of a severe neurological or medical condition that may interfere with participation in the study
- Presence of a severe psychiatric or behavioral condition that may interfere with participation in the group-based intervention
- Significant sensory or physical impairment that would prevent participation in the intervention or assessments
- Concurrent participation in another structured intervention program targeting executive function during the study period
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 |
|---|---|---|
| Executive Function Training ProgramA 12-week, structured, group-based executive function training program delivered once weekly to elementary school students aged 9-12 years with autism spectrum disorder (ASD) and their parents. Each weekly session includes an 80-minute child session and a 65-minute parent session. The child sessions use explicit instruction, modeling, guided practice, role-play, feedback, and home practice to teach and practice executive function strategies related to planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. In parallel, parents receive education on the same executive function topics taught to their children and review their child's home practice. Parent involvement is designed to help children apply and generalize the executive function strategies learned in the program to daily life at home, at school, and in other everyday situations. | Behavioural | Executive Function Training Group |
Primary outcome
Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
The BRIEF-2 is a parent-report questionnaire that assesses executive function behaviors in children's everyday life. The Global Executive Composite (GEC), index scores, and individual clinical scale scores will be analyzed to evaluate changes in different aspects of executive functioning. Higher T-scores indicate greater difficulties with executive functioning, whereas lower T-scores indicate fewer difficulties.
4 secondary outcomes
Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Time frame: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Emotion Regulation as Assessed by the Emotion Regulation Checklist (ERC)
Time frame: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Academic Self-Regulation as Assessed by the Academic Self-Regulation Questionnaire (SRQ-A)
Time frame: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Prosocial Self-Regulation as Assessed by the Prosocial Self-Regulation Questionnaire (SRQ-P)
Time frame: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
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.
Hee Jeong Yoo, MD., Ph.D. principal investigator
Seoul National University College of Medicine, Child and Adolescent Psychiatry Clinic Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive Function Training Program in people with Autism Spectrum Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 5 inclusion and 4 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 3 Sep 2026. 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 South Korea. 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?
Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) (time frame: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention). 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 3 Sep 2026.