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

Primary Purpose

Attention Deficit, Attention Deficit Disorder With Hyperactivity

Status
Active
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Behavioral Parent Training (BPT)
Child Training (iVR + CBT)
Sponsored by
University of Crete
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit focused on measuring immersive virtual reality (iVR), multimodal intervention, behavioral parent training, cognitive-behavioral treatment, neurodevelopmental dysfunctions, cognitive training

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Crete, Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Parent Training - Child Training (Group PC)

Child Training - Parent Training (Group CP)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

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).
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).
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).
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).

Full Information

First Posted
May 21, 2022
Last Updated
July 13, 2023
Sponsor
University of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT05391698
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Crete

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit, Attention Deficit Disorder With Hyperactivity
Keywords
immersive virtual reality (iVR), multimodal intervention, behavioral parent training, cognitive-behavioral treatment, neurodevelopmental dysfunctions, cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Training - Child Training (Group PC)
Arm Type
Experimental
Arm 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.
Arm Title
Child Training - Parent Training (Group CP)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Parent Training (BPT)
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Child Training (iVR + CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADHD Rating Scale-IV (ADHD-RS-IV) - Greek
Description
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).
Time Frame
8-16 weeks
Title
Attention Network Task
Description
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).
Time Frame
8-16 weeks
Title
Go/ No-Go Task
Description
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).
Time Frame
8-16 weeks
Title
Psychosocial Adjustment Test (Child report)
Description
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).
Time Frame
8-16 weeks
Secondary Outcome Measure Information:
Title
Working memory (WISC-V)
Description
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).
Time Frame
8-16 weeks
Title
Tower of Rethymnon (similar to Tower of Hanoi or Tower of London)
Description
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).
Time Frame
8-16 weeks
Title
Parenting Stress Index-Short Form (PSI-SF)
Description
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).
Time Frame
8-16 weeks
Title
Parenting Sense of Competence Scale (PSOC)
Description
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).
Time Frame
8-16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiota Dimitropoulou, PhD
Organizational Affiliation
University of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Crete, Department of Psychology
City
Rethymnon
ZIP/Postal Code
74100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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