A Multimodal Intervention Program for Children With Attention Deficits (Child ViReal Support Program)
NCT ID: NCT05391698
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2022-03-01
2022-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Parent Training - Child Training (Group PC)
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.
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.
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.
Child Training - Parent Training (Group CP)
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
9 Years
12 Years
ALL
No
Sponsors
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University of Crete
OTHER
Responsible Party
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Panagiota Dimitropoulou
Assistant Professor in Educational Psychology
Principal Investigators
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Panagiota Dimitropoulou, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Crete
Locations
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University of Crete, Department of Psychology
Rethymno, , Greece
Countries
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Other Identifiers
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H2020-MSCA-ITN-2018 813546
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Neo-PRISM-C ESR-12
Identifier Type: -
Identifier Source: org_study_id