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

NCT05391698 | Completed DMC

• 2 other identifiers: Neo-PRISM-C ESR-12H2020-MSCA-ITN-2018 813546
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  8-16 weeks

Secondary Outcomes (4)

• Working memory (WISC-V)

  8-16 weeks

• Tower of Rethymnon (similar to Tower of Hanoi or Tower of London)

  8-16 weeks

• Parenting Stress Index-Short Form (PSI-SF)

  8-16 weeks

• Parenting Sense of Competence Scale (PSOC)

  8-16 weeks

Study Arms (2)

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.

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.

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

Interventions

Behavioral Parent Training (BPT) BEHAVIORAL

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 - Parent Training (Group CP); Parent Training - Child Training (Group PC)

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.

Child Training - Parent Training (Group CP); Parent Training - Child Training (Group PC)

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

University of Crete, Department of Psychology

Rethymno, 74100, Greece

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Panagiota Dimitropoulou, PhD

  University of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Educational Psychology

Study Record Dates

• First Submitted: May 21, 2022
• First Posted: May 26, 2022
• Study Start: March 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

GR (1)