A Multimodal Intervention Program for Children With Attention Deficits (Child ViReal Support Program)

University of Crete

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity; Attention Deficit

Treatments: Combination Product: Child Training (iVR + CBT); Behavioral: Behavioral Parent Training (BPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05391698

H2020-MSCA-ITN-2018 813546 (Other Grant/Funding Number)

Neo-PRISM-C ESR-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Parent Training - Child Training (Group PC)

Experimental group

Description:

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.

Treatment:

Combination Product: Child Training (iVR + CBT)

Behavioral: Behavioral Parent Training (BPT)

Child Training - Parent Training (Group CP)

Experimental group

Description:

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.

Treatment:

Combination Product: Child Training (iVR + CBT)

Behavioral: Behavioral Parent Training (BPT)