Determinants of Treatment Response to State-of-the-art Interventions for Attention Deficits: Child Temperament, Cognitive Profiles and Family Dynamics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Attention Deficit
- Sponsor
- University of Crete
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Go/ No-Go Task
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Panagiota Dimitropoulou
Assistant Professor in Educational Psychology
University of Crete
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
Outcomes
Primary Outcomes
Go/ No-Go Task
Time Frame: 8-16 weeks
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)
Time Frame: 8-16 weeks
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).
ADHD Rating Scale-IV (ADHD-RS-IV) - Greek
Time Frame: 8-16 weeks
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
Time Frame: 8-16 weeks
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).
Secondary Outcomes
- Parenting Stress Index-Short Form (PSI-SF)(8-16 weeks)
- Working memory (WISC-V)(8-16 weeks)
- Tower of Rethymnon (similar to Tower of Hanoi or Tower of London)(8-16 weeks)
- Parenting Sense of Competence Scale (PSOC)(8-16 weeks)