NCT07591896

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

March 17, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

ADHDvirtual realityserious games

Outcome Measures

Primary Outcomes (1)

  • 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

    two weeks

Study Arms (2)

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.

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.

Behavioral: a VR-based episodic future thinking

Interventions

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.

executive function

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.

EF+VR-EFT

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants with incomplete or missing questionnaire data (8 cases were excluded based on this criterion in the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2026

First Posted

May 18, 2026

Study Start

June 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

May 18, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations