Adding VR-Based Episodic Future Thinking Training to Executive- Function Training for Children With ADHD: A Randomized Controlled Trial (Virtual Realit)

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 Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: executive function; Behavioral: a VR-based episodic future thinking

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: executive function; 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; 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.
Experimental: EF+VR-EFT; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ADHD; virtual reality; serious games
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: QL000008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No