Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD)

Sponsor

National Human Genome Research Institute (NHGRI) (NIH)

Overall Status

Not yet recruiting

CT.gov ID

NCT05608434

Collaborator

(none)

219

Enrollment

Location

Arms

42.8

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. A virtual reality-based game may help improve cognitive skills in children with ADHD. It may also help change how the brain functions.

Objective:

To see if a virtual reality-based game helps improve thinking skills and brain function in children with ADHD.

Eligibility:

Children aged 7 to 14 years with ADHD.

Design:

Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Blood or saliva may be collected. Participants may have an MRI scan of the brain.

Participants will receive a set of virtual reality games. The set includes 6 different games played by placing a smartphone inside a virtual reality headset. The participant will play a game for 20 minutes at least 3 days a week for 4 to 6 weeks.

The parent or caregiver will start each game using a tablet. Each of the 6 games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, and sustained attention.

Participants will have interviews each week. They will answer questions about motion sickness, eye strain, or headache.

Blood or saliva tests and the MRI may be repeated after the last game. A 6-month follow-up visit can be by phone or telehealth.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Behavioral: Floreo Virtual Reality application Behavioral: Floreo Virtual Reality application - non-adaptive	Phase 2

Detailed Description

Study Description: This study will be a randomized double-blind placebo-controlled trial examining the efficacy of a novel virtual reality (VR) adaptive cognitive training intervention for youth with ADHD in improving symptoms of inattention relative to a non-adaptive training control intervention. Prior to the main randomized trial, a proof-of concept open-label pilot study will assess the safety, tolerability, usability, feasibility, credibility and treatment expectancy of the intervention. It will also provide an initial assessment of the efficacy on the intervention in improving inattention symptoms and neuropsychological performance.

Objectives:

Primary Objective: Examine the efficacy of the Floreo VR intervention in improving symptoms of inattention in children/adolescents with ADHD.

Secondary Objectives: Examine the efficacy of the VR intervention in improving neuropsychological performance in five cognitive domains pertinent to ADHD.

Pilot Study Objective: Assess the safety, tolerability, usability, feasibility, credibility and treatment expectancy of the VR intervention. Provide an initial open-label assessment of the efficacy of the intervention.

Endpoints:

Primary Endpoint: The primary endpoint of the main trial is to investigate whether the intervention decreases symptoms of inattention as assessed using the ADHD Rating Scale-5 for Children and Adolescents (ADHD-RS-5).

A secondary aim of the main study is to investigate whether the intervention brings about improvements in performance on five neuropsychological performance indices. These are parameter A on the Rapid Visual Information Processing task (sustained attention), stop signal reaction time on the Stop Signal task (inhibitory control), visuospatial working memory as determined using number of correct responses on the Dot Matrix task, discounting steepness (parameter k) on the Delay Discounting task, a composite measure of temporal deviation on a Temporal Reproduction task, and the number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test. Pilot interventions Endpoints: Responses to structured interview items on safety, tolerability, usability, credibility and treatment expectancy of the intervention. Reports of adverse events will be used to assess safety. Feasibility will be assessed using participation and compliance rates. Usability will also be assessed using a System Usability Scale. Open-label assessments of efficacy will also be performed, using the ADHD-RS-5 inattention subscale. Secondary endpoints for the pilot study are the same as for the main study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

219 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Phase II Trial

Anticipated Study Start Date :

Feb 6, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group This group will undergo up to 20 daily sessions (20 minutes each) of the non-adaptive version of the Floreo VR training.	Behavioral: Floreo Virtual Reality application - non-adaptive This is a non-adaptive version of the Floreo VR application, created to serve as a control intervention in the present study. This control intervention will consist of the same training modules, but the performance demands will be kept low.
Experimental: Floreo VR group This group will undergo up to 20 daily sessions (20 minutes each) of the Floreo VR training.	Behavioral: Floreo Virtual Reality application Floreo VR is a novel VR-based cognitive training therapy for ADHD. It incorporates multiple learning modules, each of which targets a neuropsychological domain relevant to ADHD (inhibitory control, sustained attention, working memory, delay discounting, temporal processing, processing speed). The demands of the training intervention adapt to the subject s practice-driven improvements in performance. Specifically, when the subject is deemed to perform adequately well at a given level of difficulty, the training adapts by presenting a more challenging difficulty. This adaptation to the subject s performance is designed to allow for continued incremental improvements in the trained domains. The VR games take place in a spaceship themed environment. The VR training is designed to be used at home, under the supervision of a parent.

Arm

Intervention/Treatment

Placebo Comparator: control group

This group will undergo up to 20 daily sessions (20 minutes each) of the non-adaptive version of the Floreo VR training.

Behavioral: Floreo Virtual Reality application - non-adaptive

This is a non-adaptive version of the Floreo VR application, created to serve as a control intervention in the present study. This control intervention will consist of the same training modules, but the performance demands will be kept low.

Experimental: Floreo VR group

This group will undergo up to 20 daily sessions (20 minutes each) of the Floreo VR training.

Behavioral: Floreo Virtual Reality application

Floreo VR is a novel VR-based cognitive training therapy for ADHD. It incorporates multiple learning modules, each of which targets a neuropsychological domain relevant to ADHD (inhibitory control, sustained attention, working memory, delay discounting, temporal processing, processing speed). The demands of the training intervention adapt to the subject s practice-driven improvements in performance. Specifically, when the subject is deemed to perform adequately well at a given level of difficulty, the training adapts by presenting a more challenging difficulty. This adaptation to the subject s performance is designed to allow for continued incremental improvements in the trained domains. The VR games take place in a spaceship themed environment. The VR training is designed to be used at home, under the supervision of a parent.

Outcome Measures

Primary Outcome Measures

ADHD-RS-5 inattention sub-scale. [within one month of the end of VR training]
The ADHD-RS-569 is a rating scale based on the diagnostic criteria for ADHD as described in the DSM-51. Inattention symptoms are one of two key symptom domains for ADHD, and the target of the present intervention.

Secondary Outcome Measures

Stop signal reaction time on the Stop Signal task (inhibitory control) [within one month of the end of VR training]
Computerized neuropsychological assessment of inhibitory control
discounting steepness (parameter k) on the Delay Discounting task [within one month of the end of VR training]
Computerized neuropsychological assessment of delay discounting
Parameter A' on the Rapid Visual Information Processing task (sustained attention); [within one month of the end of VR training]
Computerized neuropsychological assessment of sustained attention
Temporal deviation on a temporal reproduction task [within one month of the end of VR training]
Computerized neuropsychological assessment of motor-timing
Number of correct responses on the Dot Matrix task [within one month of the end of VR training]
Computerized neuropsychological assessment of working memory
Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test. [within one month of the end of VR training]
Computerized neuropsychological assessment of processing speed

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

In order to be eligible to participate, an individual must meet all of the following criteria:

Children must provide informed assent and parents must provide informed consent to participate in the study.
Any gender identity, sex assigned at birth or race/ethnicity.
Aged between 7 and 14 years of age.
Diagnosis of ADHD. All forms of ADHD, including otherwise specified presentation.
Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
Unmedicated or treated for ADHD with stimulants under a treatment regimen that has been stable for at least four weeks.

For the pilot trial, the participants will be 30 children/adolescents with ADHD. All other criteria will be the same as for the main study.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)
History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.
Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.
Known to be pregnant.
Psychotic disorders (including schizophrenia, psychosis not otherwise specified) or current substance dependence. Participant is considered a suicide risk in the opinion of the PI.
Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g. limitations in mobility that would render the VR headset unusable).