Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorMerja Nikula
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of ADHD (ICD-10 F90.0) and
Methylphenidate medication and
Age 8-12 years and
Finnish as a native language
Disqualifiers
Sensitivity to flashing light,
Epilepsy (ICD-10 G40),
Mental retardation (ICD-10 F70-F79),
Pervasive developmental disorders (ICD-10 F84),
Trial design
Design model
Parallel
Treatments tested in this trial
Parental Guidance
BehavioralParents 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 Game
BehavioralVirtual 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.
Treatment groups
88 Participants
are divided into 4 treatment groupsGroup A: Parental Guidance+Virtual Reality GameExperimental treatment 2 interventions
Group B: Parental GuidanceExperimental treatment 1 intervention
Group C: Virtual Reality GameExperimental treatment 1 intervention
Group D: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.2
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.3
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.4
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.Secondary outcomes
1
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.2
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.3
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.4
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.
Time frame
Baseline, 4-6 weeks, 6 months and 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Merja Nikula
Lead sponsor
Oulu University Hospital
Sponsor institution
University of Oulu
Collaborator
Aalto University
Collaborator
University of Helsinki
Collaborator
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov