Clinical trial NCT05391698: A Multimodal Intervention Program for Children With Attention Deficits (Child ViReal Support Program)
Official title: Determinants of Treatment Response to State-of-the-art Interventions for Attention Deficits: Child Temperament, Cognitive Profiles and Family Dynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit
Attention Deficit Disorder With Hyperactivity
Keywords: immersive virtual reality (iVR)
multimodal intervention
behavioral parent training
cognitive-behavioral treatment
neurodevelopmental dysfunctions
cognitive training
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 16
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ADHD Rating Scale-IV (ADHD-RS-IV) - Greek
timeFrame: 8-16 weeks
measure: Attention Network Task
timeFrame: 8-16 weeks
measure: Go/ No-Go Task
timeFrame: 8-16 weeks
measure: Psychosocial Adjustment Test (Child report)
timeFrame: 8-16 weeks
Secondary outcomes:
measure: Working memory (WISC-V)
timeFrame: 8-16 weeks
measure: Tower of Rethymnon (similar to Tower of Hanoi or Tower of London)
timeFrame: 8-16 weeks
measure: Parenting Stress Index-Short Form (PSI-SF)
timeFrame: 8-16 weeks
measure: Parenting Sense of Competence Scale (PSOC)
timeFrame: 8-16 weeks
Other outcomes:
Locations:
city: Rethymnon
country: Greece
facility: University of Crete, Department of Psychology
Study officials:
affiliation: University of Crete
name: Panagiota Dimitropoulou, PhD
role: PRINCIPAL_INVESTIGATOR
References: