ADHDVirtual RealitNCT07591896
Adding VR-Based Episodic Future Thinking Training to Executive- Function Training for Children With ADHD: A Randomized Controlled Trial
A study testing executive function and a VR-based episodic future thinking in people with ADHD, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study recruited 80 children aged 5-12 with clinically diagnosed ADHD from Qilu Hospital, Shandong University, and randomly divided them into two groups with 40 children in each group: the EF-only group and the EF+VR-EFT group. Both groups received a 2-week intervention with 5 sessions per week Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- executive function and a VR-based episodic future thinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Dec 2025
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5-12 years with a clinical diagnosis of ADHD confirmed by a multidisciplinary clinical team according to DSM-5 criteria.
- Normal intellectual functioning.
- Absence of major neurological or medical disorders.
Who cannot join
- Participants with incomplete or missing questionnaire data (8 cases were excluded based on this criterion in the study).
Trial locations and contacts
1 site in 1 country.
About this study
This study recruited 80 children aged 5-12 with clinically diagnosed ADHD from Qilu Hospital, Shandong University, and randomly divided them into two groups with 40 children in each group: the EF-only group and the EF+VR-EFT group. Both groups received a 2-week intervention with 5 sessions per week
Read the detailed description
This study recruited 80 children aged 5-12 with clinically diagnosed ADHD from Qilu Hospital, Shandong University, and randomly divided them into two groups with 40 children in each group: the EF-only group and the EF+VR-EFT group. Both groups received a 2-week intervention with 5 sessions per week
- Conditions
- ADHD
- Being tested
- executive function, a VR-based episodic future thinking
- Keywords
- ADHD, virtual reality, serious games
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
executive functionBehavioural
Control Group (EF-only group): Participants received a 2-week standardized, non-immersive conventional executive function (EF) training, with 6 sessions per week (45 minutes per session) under researcher supervision, targeting core executive processes such as inhibitory control and working memory.
Experimental Group (EF+VR-EFT group): On the basis of the same conventional EF training as the control group, participants additionally completed a 20-minute VR-based episodic future thinking (VR-EFT) module per session, delivered via PICO headsets through immersive gameplay in a controlled clinical setting.
a VR-based episodic future thinkingBehavioural
Experimental Group (EF+VR-EFT group): On the basis of the same 2-week conventional EF training, participants additionally completed a VR-based episodic future thinking (VR-EFT) module in each session. Their executive function achieved more significant and stable improvements, particularly in higher-order domains.
| Study group | Role | What they receive |
|---|---|---|
| executive function | Active comparator | All participants received 2 weeks of conventional executive function (EF) training (6 sessions per week). After the intervention, their executive function improved slightly, with small changes in higher-order processes such as inhibitory control and metacognition. Receives: Behavioral: executive function |
| EF+VR-EFT | Experimental | Experimental Group (EF+VR-EFT group): On the basis of the same conventional EF training as the control group, participants additionally completed a 20-minute VR-based episodic future thinking (VR-EFT) module per session, delivered via PICO headsets through immersive gameplay in a controlled clinical setting. Receives: Behavioral: a VR-based episodic future thinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
BRIEF score
The main outcome measures of the study were assessed via the BRIEFfocusing on executive function changes after the 2-week intervention,BRIEF-assessed executive function changes, with specific difficulty score reductions in inhibition and metacognition
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2024
- Primary completion1 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591896
- Sponsor's protocol ID
- QL000008
- Acronym
- Virtual Realit
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding VR-Based Episodic Future Thinking Training to Executive- Function Training for Children With ADHD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07591896
- Acronym / sponsor ID
- Virtual Realit / QL000008
- Conditions
- ADHD
- Keywords
- ADHD, virtual reality, serious games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 18 May 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.
This study recruited 80 children aged 5-12 with clinically diagnosed ADHD from Qilu Hospital, Shandong University, and randomly divided them into two groups with 40 children in each group: the EF-only group and the EF+VR-EFT group. Both groups received a 2-week intervention with 5 sessions per week
Detailed description
This study recruited 80 children aged 5-12 with clinically diagnosed ADHD from Qilu Hospital, Shandong University, and randomly divided them into two groups with 40 children in each group: the EF-only group and the EF+VR-EFT group. Both groups received a 2-week intervention with 5 sessions per week
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| executive function | Active comparator | Behavioral: executive functionAll participants received 2 weeks of conventional executive function (EF) training (6 sessions per week). After the intervention, their executive function improved slightly, with small changes in higher-order processes such as inhibitory control and metacognition. |
| EF+VR-EFT | Experimental | Behavioral: a VR-based episodic future thinkingExperimental Group (EF+VR-EFT group): On the basis of the same conventional EF training as the control group, participants additionally completed a 20-minute VR-based episodic future thinking (VR-EFT) module per session, delivered via PICO headsets through immersive gameplay in a controlled clinical setting. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 5-12 years with a clinical diagnosis of ADHD confirmed by a multidisciplinary clinical team according to DSM-5 criteria.
- Normal intellectual functioning.
- Absence of major neurological or medical disorders.
Key exclusion criteria (1 listed)
- Participants with incomplete or missing questionnaire data (8 cases were excluded based on this criterion in the study).
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 functionControl Group (EF-only group): Participants received a 2-week standardized, non-immersive conventional executive function (EF) training, with 6 sessions per week (45 minutes per session) under researcher supervision, targeting core executive processes such as inhibitory control and working memory. Experimental Group (EF+VR-EFT group): On the basis of the same conventional EF training as the control group, participants additionally completed a 20-minute VR-based episodic future thinking (VR-EFT) module per session, delivered via PICO headsets through immersive gameplay in a controlled clinical setting. | Behavioural | executive function |
| a VR-based episodic future thinkingExperimental Group (EF+VR-EFT group): On the basis of the same 2-week conventional EF training, participants additionally completed a VR-based episodic future thinking (VR-EFT) module in each session. Their executive function achieved more significant and stable improvements, particularly in higher-order domains. | Behavioural | EF+VR-EFT |
Primary outcome
BRIEF score
Time frame: two weeks
The main outcome measures of the study were assessed via the BRIEFfocusing on executive function changes after the 2-week intervention,BRIEF-assessed executive function changes, with specific difficulty score reductions in inhibition and metacognition
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 18 May 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and a VR-based episodic future thinking in people with ADHD, run by Qilu Hospital of Shandong University 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?
The sponsor lists 3 inclusion and 1 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 18 May 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 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.
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?
BRIEF score (time frame: two weeks). 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 18 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.