Attention Deficit Hyperactivity DisorderVREALFUN-ADHDNCT06123741
Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.
A study testing Parental Guidance and Virtual Reality Game in people with Attention Deficit Hyperactivity Disorder, run by Merja Nikula at 1 site in Finland.
Trial summary
Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Parental Guidance and Virtual Reality Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFinland
- Study dates
- 10 Jan 2024to 31 Dec 2028
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of ADHD (ICD-10 F90.0) and
- Methylphenidate medication and
- Age 8-12 years and
- Finnish as a native language
Who cannot join
- Sensitivity to flashing light,
- Epilepsy (ICD-10 G40),
- Mental retardation (ICD-10 F70-F79),
- Pervasive developmental disorders (ICD-10 F84),
- Inflammatory diseases of the central nervous system (ICD-10 G00-G09),
- Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),
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- Traumatic brain injury ((ICD-10 S06),
- Brain tumour, and
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johanna Uusimaa, MD, PhD contact
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu, 90029
Merja Nikula, M.Psych., merja.nikula@pohde.fi
Johanna Uusimaa, MD, PhD, johanna.uusimaa@pohde.fi
About this study
Official title: Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)
Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.
The major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.
Researchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Parental Guidance, Virtual Reality Game
- Keywords
- Attention Deficit Hyperactivity Disorder, Attention, Executive Function, Virtual Reality, Child
- 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.
Parental GuidanceBehavioural
Also called Self-Help Program of children's challenging behaviour (Program name in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).
Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma) .
Virtual Reality GameBehavioural
Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home.
| Study group | Role | What they receive |
|---|---|---|
| Parental Guidance+Virtual Reality Game | Experimental | Not described Receives: Behavioral: Parental Guidance; Behavioral: Virtual Reality Game |
| Parental Guidance | Experimental | Not described Receives: Behavioral: Parental Guidance |
| Virtual Reality Game | Experimental | Not described Receives: Behavioral: Virtual Reality Game |
| Control Group | No intervention | This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epeli (Executive Performance in Everyday LIving) task
A virtual reality task for attention, executive function, and prospective memory. Change in total score, task efficacy, navigation efficacy, controller motion, and total action.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
ADHD-rating scale IV (ADHD-RS) (parent report)
The ADHD-RS (parent report) is an assessment of a child's ADHD symptoms with 18 items based on the child's behaviour over the past 6 months. 4-point Likert scale. The total score ranges 0-54, scores in inattention subscale and hyperactivity/impulsivity subscale range 0-27. Change in the total score, inattention subscale score, and hyperactivity/impulsivity subscale score on a parent-rated ADHD-RS. A lower score means a better outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Epeli Questionnaire (parent report)
An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on parent-rated Epeli- questionnaire. A higher score means a better outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Epeli Questionnaire (child report)
An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on child-rated Epeli- questionnaire. A higher score means a better outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Secondary outcomes (7)
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the parent. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on parent-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)
A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the teacher. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on teacher-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Concentration questionnaire (in Finnish: Keskittymiskysely)
An assessment of attention and executive function difficulties in school-aged children with 55 items. 3-point Likert Scale, Total score range 0-110. Change in Total score, Distractibility score (range 0-8), sum of Impulsivity and Motor hyperactivity subscales scores (range 0-32), sum of Directing, Sustaining and Shifting Attention subscales scores (range 0-30), and sum of Initiative, Planning, Execution and Evaluation of Action subscales scores (range 0-40) on teacher-rated Concentration questionnaire. In case the data in the Distractibility subscale, Impulsivity and Motor hyperactivity subscales, Attention subscales and Executive subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on Concentration questionnaire Total score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score implies a worse outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)
An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on parent-rated questionnaire. A higher score means a better outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)
An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on child-rated questionnaire. A higher score means a better outcome.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
N-back test
A test for a working memory. Change in 2-back and 1-back hitrate and reaction time.
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
The Conners Continuous Performance Test 3rd Edition (Conners CPT3)
A computerized attention task validated in individuals aged 8 years and older. Change in scores on Conners Continuous Performance Test (CPT-3).
Measured: Baseline, 4-6 weeks, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start10 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merja Nikula
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Aalto University, University of Helsinki, Helsinki University Central Hospital
- Responsible party
- Sponsor-investigator, Merja Nikula, Oulu University Hospital
- Investigators
- Johanna Uusimaa, MD, PhD, Study chair, Oulu University HospitalMerja Nikula, M.Psych., Principal investigator, Oulu University HospitalMirjami Mäntymaa, MD, PhD, Study director, Oulu University HospitalJuha Salmitaival, PhD, Study director, University of Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123741
- Sponsor's protocol ID
- 206/2021
- Acronym
- VREALFUN-ADHD
- Status last verified
- Nov 2026
- First submitted
- 28 Sep 2023
- Last updated
- 3 Nov 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)
- ClinicalTrials.gov ID
- NCT06123741
- Acronym / sponsor ID
- VREALFUN-ADHD / 206/2021
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Attention, Executive Function, Virtual Reality, Child
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Merja NikulaUniversity, hospital or other
- Collaborators
- University of Oulu, Aalto University, University of Helsinki, Helsinki University Central Hospital
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Nov 2023 (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.
Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.
The major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.
Researchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parental Guidance+Virtual Reality Game | Experimental | Behavioral: Parental Guidance, Behavioral: Virtual Reality Game |
| Parental Guidance | Experimental | Behavioral: Parental Guidance |
| Virtual Reality Game | Experimental | Behavioral: Virtual Reality Game |
| Control Group | No intervention | –This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of ADHD (ICD-10 F90.0) and
- Methylphenidate medication and
- Age 8-12 years and
- Finnish as a native language
Key exclusion criteria (9 listed)
- Sensitivity to flashing light,
- Epilepsy (ICD-10 G40),
- Mental retardation (ICD-10 F70-F79),
- Pervasive developmental disorders (ICD-10 F84),
- Inflammatory diseases of the central nervous system (ICD-10 G00-G09),
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 |
|---|---|---|
| Parental GuidanceAlso: Self-Help Program of children's challenging behaviour (Program name in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma) . | Behavioural | Parental Guidance, Parental Guidance+Virtual Reality Game |
| Virtual Reality GameVirtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home. | Behavioural | Parental Guidance+Virtual Reality Game, Virtual Reality Game |
Primary outcome
Epeli (Executive Performance in Everyday LIving) task
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
A virtual reality task for attention, executive function, and prospective memory. Change in total score, task efficacy, navigation efficacy, controller motion, and total action.
ADHD-rating scale IV (ADHD-RS) (parent report)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
The ADHD-RS (parent report) is an assessment of a child's ADHD symptoms with 18 items based on the child's behaviour over the past 6 months. 4-point Likert scale. The total score ranges 0-54, scores in inattention subscale and hyperactivity/impulsivity subscale range 0-27. Change in the total score, inattention subscale score, and hyperactivity/impulsivity subscale score on a parent-rated ADHD-RS. A lower score means a better outcome.
Epeli Questionnaire (parent report)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on parent-rated Epeli- questionnaire. A higher score means a better outcome.
Epeli Questionnaire (child report)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on child-rated Epeli- questionnaire. A higher score means a better outcome.
7 secondary outcomes
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
Concentration questionnaire (in Finnish: Keskittymiskysely)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
N-back test
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
The Conners Continuous Performance Test 3rd Edition (Conners CPT3)
Time frame: Baseline, 4-6 weeks, 6 months and 12 months.
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 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Johanna Uusimaa, MD, PhD contact
Johanna Uusimaa, MD, PhD study chair
Oulu University Hospital
Merja Nikula, M.Psych. principal investigator
Oulu University Hospital
Mirjami Mäntymaa, MD, PhD study director
Oulu University 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 Parental Guidance and Virtual Reality Game in people with Attention Deficit Hyperactivity Disorder, run by Merja Nikula at 1 site in Finland.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 Finland. 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?
Contact Merja Nikula, M.Psych. (+3588315 5218, merja.nikula@pohde.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epeli (Executive Performance in Everyday LIving) task (time frame: Baseline, 4-6 weeks, 6 months and 12 months.). The study lists 4 primary outcomes in all. 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 Nov 2026.