Attention DeficitNCT05391698
A Multimodal Intervention Program for Children With Attention Deficits (Child ViReal Support Program)
A study testing Behavioral Parent Training (BPT) and Child Training (iVR + CBT) in people with Attention Deficit and Attention Deficit Disorder With Hyperactivity, run by University of Crete at 1 site in Greece.
Trial summary
The main aim of this study is the development and implementation of a multimodal intervention program consisting of parent training and child training which utilizes the potentials of immersive virtual reality technology (iVR) in order to test its effectiveness for children with attention deficits. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Attention Deficit, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Behavioral Parent Training (BPT) and Child Training (iVR + CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants 9-12 years old and their parents
- ADHD diagnosis (by the approved body of Ministry of Health)
- Greek speaking participants (child and parents)
- Full Scale IQ > 80 (WISC-V) for child
- Naïve drug treatment for ADHD
- Participants able to comply with all testing and study requirements
Who cannot join
- Treatment with psychostimulants or other psychotropic drugs
- Children who received intervention based on CBT or parents who attended other behavior parent training programs
- History of comorbid neurological disorders, seizure disorder, autism spectrum disorders, psychosis, or severe dysregulation disorders that may interfere with study participation or use of virtual reality equipment
- Participants presenting a hearing or vision impairment that does not allow the tasks to be performed with the use virtual reality equipment
- Intellectual disability or WISC-V full scale IQ < 78 (1.5 standard deviations (SD) below mean)
- Non-Greek speaking child or parent
- Parents or children who refuse to give written consent for their participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Treatment Response to State-of-the-art Interventions for Attention Deficits: Child Temperament, Cognitive Profiles and Family Dynamics
The main aim of this study is the development and implementation of a multimodal intervention program consisting of parent training and child training which utilizes the potentials of immersive virtual reality technology (iVR) in order to test its effectiveness for children with attention deficits.
Read the detailed description
Attention deficits are commonly observed in children and attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed childhood neurodevelopmental disorders. It is evidently known that attention deficits affect children's school, social and family life making it essential for them and their parents to receive specialized supportive services. Behavioral parent training (BPT) and cognitive-behavioral treatment (CBT) are considered evidence-based interventions for children with ADHD. In fact, they have positive effects on the management of children's behaviors, organization, reduction of parental stress and enhancement of parental self-efficacy. In addition to these traditional evidence-based interventions, immersive virtual reality (iVR) technology has been applied lately as part of intervention programs for children with attention deficits / ADHD diagnosis specifically for cognitive training.
In line with the above, investigators have designed and developed a multimodal intervention program named Child ViReal Support program. This program is comprised of parent training and child training and utilizes the potentials of iVR technology. In order to assess the efficacy of Child ViReal Support program, the investigators will conduct a randomized controlled trial, which consists of a pre-training phase, a training phase, a post-training phase and a follow-up.
- Being tested
- Behavioral Parent Training (BPT), Child Training (iVR + CBT)
- Keywords
- immersive virtual reality (iVR), multimodal intervention, behavioral parent training, cognitive-behavioral treatment, neurodevelopmental dysfunctions, cognitive training
- 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.
Behavioral Parent Training (BPT)Behavioural
The parent training consists of 8 weekly group sessions where parents are trained on behavior modification techniques, optimal parental practices as well as techniques for the enhancement of their children's cognitive deficits.
Child Training (iVR + CBT)Combination product
The child training program is comprised of 16 individualized weekly sessions. It utilizes the potentials of immersive virtual reality (iVR) technology for the training of focused and sustained attention and combines practices based on cognitive-behavioral approach for children's training on behavioral and emotional self-regulation skills.
| Study group | Role | What they receive |
|---|---|---|
| Parent Training - Child Training (Group PC) | Experimental | Parents of families who will be randomized in Group PC will first take part in behavioral parent training. After the completion of the parent training program and the assessment (Time 2 assessment), their children will take part in the individualized child training program. Receives: Behavioral: Behavioral Parent Training (BPT); Combination Product: Child Training (iVR + CBT) |
| Child Training - Parent Training (Group CP) | Experimental | Children of families who will be randomized in Group CP will first take part in the individualized child training program. After the completion of the child training program and the assessment (Time 2 assessment), parents will take part in the behavioral parent training program. Receives: Behavioral: Behavioral Parent Training (BPT); Combination Product: Child Training (iVR + CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale-IV (ADHD-RS-IV) - Greek
ADHD Rating Scale-IV (Greek version, parent report) is a clinician-administered questionnaire completed by the child's parents. The scale consists of 18 questions that assess inattention (9 items) and hyperactivity/impulsivity (9 items). The total score is obtained by adding the raw scores of Inattention subscale and Hyperactivity/impulsivity subscale. Each item is rated on a 4-point Likert scale (0=Never or Rarely, 1=Sometimes, 2=Often, 3=Very Often) with total scores ranging from 0-54, while inattention subscale score and hyperactivity/impulsivity subscale score range from 0-27 each. A higher score indicates more severe ADHD symptoms.
Changes in scores of Inattention subscale, Hyperactivity/Impulsivity subscale and Total Score will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Attention Network Task
Attention Network Task (ANT child version) is a computerized task that was developed to measure the three networks of attention in children as described by Posner and colleagues, namely the alerting network, the orienting network and the executive control network.
The scores for each network are obtained by reaction time subtractions of different stimulus combinations (cues, congruent conditions, incongruent conditions).
Changes in scores of alerting network, orienting network and executive control network will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Go/ No-Go Task
Go/No-Go task is a computerized task that was developed to measure attention and response inhibition. The task was developed by the research team in accordance with Conner's CPT-III task and the participant responds to certain stimuli (Go-trials) and withhold response to other stimuli (No-Go trials). There are 6 blocks of 60 trials (80% go-trials, 20% no-go trials) and there are four scores obtained from participants' responses: 1) Correct hits rate, 2) Omission error rate (do not respond in a target, inattention), 3) Commission error rate (response on a no-go trial, impulsivity) and 4) Reaction time of response on a go-trial (slower RT shows inattention).
Changes in: 1) average correct hits rate, 2) average number of omission errors, 3) average number of commission errors and 4) reaction time variability will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Psychosocial Adjustment Test (Child report)
Psychosocial Adjustment Test is an assessment tool for the timely detection of children's skills or deficiencies in the social and emotional areas of their lives, in school adaptation as well as for the detection of difficulties in intrapersonal or interpersonal adaptation. It consists of 115 questions in a 5-point Likert scale (1=Not at all, 2=A little, 3=Moderate, 4=Very, 5=Too much) that yield five different factors: 1) Social adequacy, 2) School adequacy, 3) Emotional adequacy, 4) Self-perception and 5) Behavioral problems.
Changes in 1) Social adequacy, 2) Emotional adequacy and 3) Behavioral problems will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Secondary outcomes (4)
Working memory (WISC-V)
Working Memory Index (WISC-V) measures a child's ability to register, maintain and manipulate visual and auditory information in mind. Working Memory Index from WISC-V consists of two subscales: Digit Span and Picture Span.
Changes in Working Memory Index results will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Tower of Rethymnon (similar to Tower of Hanoi or Tower of London)
Tower of Rethymnon is a subtest included in the Detection and Evaluation Tool for Executive Functions and it is an adaptation of the Tower of London. This test evaluates the ability to plan, to use cognitive control and to solve problems in non-verbal contexts.
Changes in Tower of Rethymnon results will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Parenting Stress Index-Short Form (PSI-SF)
Parenting Stress Index-Short Form (PSI-SF) is a parent-report questionnaire that evaluates parenting stress, which is a variable affected by child's characteristics, parent's characteristics and by the situations surrounding their relationship. It consists of 36 items and results in five subcategories of parenting stress: 1) Parental Distress Score, 2) Parent-Child Dysfunctional Interaction Score, 3) Difficult Child Score, 4) Total Stress Score and 4) Defensive Responding Score.
Changes in the above five scores will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Parenting Sense of Competence Scale (PSOC)
Parenting Sense of Competence Scale (PSOC) is a parent-report questionnaire that evaluates the parents' sense and perception regarding their parental ability and adequacy. It consists of 17 items and results in a Total PSOC Score. Higher score indicates greater sense of parental adequacy.
Changes in Total PSOC Score will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Measured: 8-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Mar 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention DeficitStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiota Dimitropoulou, University of Crete
- Investigators
- Panagiota Dimitropoulou, PhD, Principal investigator, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391698
- Sponsor's protocol ID
- Neo-PRISM-C ESR-12
- Other IDs
- H2020-MSCA-ITN-2018 813546
- Status last verified
- Nov 2023
- First submitted
- 21 May 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pachiti I, Milienos FS, Papadopoulos TC, Dimitropoulou P. Child training in the Child ViReal Support Program: Combining iVR-based cognitive training and CBT techniques in a pilot study. PLoS One. 2026 Feb 27;21(2):e0343364. doi: 10.1371/journal.pone.0343364. eCollection 2026.
PubMed 41758830
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Treatment Response to State-of-the-art Interventions for Attention Deficits: Child Temperament, Cognitive Profiles and Family Dynamics
- ClinicalTrials.gov ID
- NCT05391698
- Acronym / sponsor ID
- Neo-PRISM-C ESR-12
- Keywords
- immersive virtual reality (iVR), multimodal intervention, behavioral parent training, cognitive-behavioral treatment, neurodevelopmental dysfunctions, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 26 May 2022 (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.
The main aim of this study is the development and implementation of a multimodal intervention program consisting of parent training and child training which utilizes the potentials of immersive virtual reality technology (iVR) in order to test its effectiveness for children with attention deficits.
Detailed description
Attention deficits are commonly observed in children and attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed childhood neurodevelopmental disorders. It is evidently known that attention deficits affect children's school, social and family life making it essential for them and their parents to receive specialized supportive services. Behavioral parent training (BPT) and cognitive-behavioral treatment (CBT) are considered evidence-based interventions for children with ADHD. In fact, they have positive effects on the management of children's behaviors, organization, reduction of parental stress and enhancement of parental self-efficacy. In addition to these traditional evidence-based interventions, immersive virtual reality (iVR) technology has been applied lately as part of intervention programs for children with attention deficits / ADHD diagnosis specifically for cognitive training.
In line with the above, investigators have designed and developed a multimodal intervention program named Child ViReal Support program. This program is comprised of parent training and child training and utilizes the potentials of iVR technology. In order to assess the efficacy of Child ViReal Support program, the investigators will conduct a randomized controlled trial, which consists of a pre-training phase, a training phase, a post-training phase and a follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Training - Child Training (Group PC) | Experimental | Behavioral: Behavioral Parent Training (BPT), Combination Product: Child Training (iVR + CBT)Parents of families who will be randomized in Group PC will first take part in behavioral parent training. After the completion of the parent training program and the assessment (Time 2 assessment), their children will take part in the individualized child training program. |
| Child Training - Parent Training (Group CP) | Experimental | Behavioral: Behavioral Parent Training (BPT), Combination Product: Child Training (iVR + CBT)Children of families who will be randomized in Group CP will first take part in the individualized child training program. After the completion of the child training program and the assessment (Time 2 assessment), parents will take part in the behavioral parent training program. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants 9-12 years old and their parents
- ADHD diagnosis (by the approved body of Ministry of Health)
- Greek speaking participants (child and parents)
- Full Scale IQ > 80 (WISC-V) for child
- Naïve drug treatment for ADHD
Key exclusion criteria (7 listed)
- Treatment with psychostimulants or other psychotropic drugs
- Children who received intervention based on CBT or parents who attended other behavior parent training programs
- History of comorbid neurological disorders, seizure disorder, autism spectrum disorders, psychosis, or severe dysregulation disorders that may interfere with study participation or use of virtual reality equipment
- Participants presenting a hearing or vision impairment that does not allow the tasks to be performed with the use virtual reality equipment
- Intellectual disability or WISC-V full scale IQ < 78 (1.5 standard deviations (SD) below mean)
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 |
|---|---|---|
| Behavioral Parent Training (BPT)The parent training consists of 8 weekly group sessions where parents are trained on behavior modification techniques, optimal parental practices as well as techniques for the enhancement of their children's cognitive deficits. | Behavioural | Child Training - Parent Training (Group CP), Parent Training - Child Training (Group PC) |
| Child Training (iVR + CBT)The child training program is comprised of 16 individualized weekly sessions. It utilizes the potentials of immersive virtual reality (iVR) technology for the training of focused and sustained attention and combines practices based on cognitive-behavioral approach for children's training on behavioral and emotional self-regulation skills. | Combination product | Child Training - Parent Training (Group CP), Parent Training - Child Training (Group PC) |
Primary outcome
ADHD Rating Scale-IV (ADHD-RS-IV) - Greek
Time frame: 8-16 weeks
ADHD Rating Scale-IV (Greek version, parent report) is a clinician-administered questionnaire completed by the child's parents. The scale consists of 18 questions that assess inattention (9 items) and hyperactivity/impulsivity (9 items). The total score is obtained by adding the raw scores of Inattention subscale and Hyperactivity/impulsivity subscale. Each item is rated on a 4-point Likert scale (0=Never or Rarely, 1=Sometimes, 2=Often, 3=Very Often) with total scores ranging from 0-54, while inattention subscale score and hyperactivity/impulsivity subscale score range from 0-27 each. A higher score indicates more severe ADHD symptoms. Changes in scores of Inattention subscale, Hyperactivity/Impulsivity subscale and Total Score will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Attention Network Task
Time frame: 8-16 weeks
Attention Network Task (ANT child version) is a computerized task that was developed to measure the three networks of attention in children as described by Posner and colleagues, namely the alerting network, the orienting network and the executive control network. The scores for each network are obtained by reaction time subtractions of different stimulus combinations (cues, congruent conditions, incongruent conditions). Changes in scores of alerting network, orienting network and executive control network will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Go/ No-Go Task
Time frame: 8-16 weeks
Go/No-Go task is a computerized task that was developed to measure attention and response inhibition. The task was developed by the research team in accordance with Conner's CPT-III task and the participant responds to certain stimuli (Go-trials) and withhold response to other stimuli (No-Go trials). There are 6 blocks of 60 trials (80% go-trials, 20% no-go trials) and there are four scores obtained from participants' responses: 1) Correct hits rate, 2) Omission error rate (do not respond in a target, inattention), 3) Commission error rate (response on a no-go trial, impulsivity) and 4) Reaction time of response on a go-trial (slower RT shows inattention). Changes in: 1) average correct hits rate, 2) average number of omission errors, 3) average number of commission errors and 4) reaction time variability will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
Psychosocial Adjustment Test (Child report)
Time frame: 8-16 weeks
Psychosocial Adjustment Test is an assessment tool for the timely detection of children's skills or deficiencies in the social and emotional areas of their lives, in school adaptation as well as for the detection of difficulties in intrapersonal or interpersonal adaptation. It consists of 115 questions in a 5-point Likert scale (1=Not at all, 2=A little, 3=Moderate, 4=Very, 5=Too much) that yield five different factors: 1) Social adequacy, 2) School adequacy, 3) Emotional adequacy, 4) Self-perception and 5) Behavioral problems. Changes in 1) Social adequacy, 2) Emotional adequacy and 3) Behavioral problems will be evaluated before, during and after the intervention as well as at a follow-up assessment (3-4 months after the end of the intervention program).
4 secondary outcomes
Working memory (WISC-V)
Time frame: 8-16 weeks
Tower of Rethymnon (similar to Tower of Hanoi or Tower of London)
Time frame: 8-16 weeks
Parenting Stress Index-Short Form (PSI-SF)
Time frame: 8-16 weeks
Parenting Sense of Competence Scale (PSOC)
Time frame: 8-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 41758830Pachiti I, Milienos FS, Papadopoulos TC, Dimitropoulou P. Child training in the Child ViReal Support Program: Combining iVR-based cognitive training and CBT techniques in a pilot study. PLoS One. 2026 Feb 27;21(2):e0343364. doi: 10.1371/journal.pone.0343364. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Panagiota Dimitropoulou, PhD principal investigator
University of Crete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Parent Training (BPT) and Child Training (iVR + CBT) in people with Attention Deficit and Attention Deficit Disorder With Hyperactivity, run by University of Crete at 1 site in Greece.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 29 Nov 2023. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale-IV (ADHD-RS-IV) - Greek (time frame: 8-16 weeks). 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?
On the ClinicalTrials.gov record for NCT05391698, which also lists 1 linked publication.
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 29 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.