NeuroTrainer Cognitive Training For Academic Focus
NCT Number: NCT06512974
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ADHD - Combined Type|ADHD Predominantly Inattentive Type|ADHD, Predominantly Hyperactive - Impulsive
Interventions: BEHAVIORAL: NeuroTrainer
Sponsor: NeuroTrainer
Collaborators: National Institute of Mental Health (NIMH)|University of California, Davis
Sex: ALL
Age: CHILD
Enrollment: 155
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-02-28

Summary:
This clinical trial aims to evaluate the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control functions in students with and without attention-related difficulties.

Primary Outcome Measures: NIH Toolbox Flanker Inhibitory Control and Attention Test (RT), This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the reaction time (RT) outcome from this assessment., Week 1, Month 2, Month 3, Month 9|NIH Toolbox Flanker Inhibitory Control and Attention Test (IIV-RT), This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment., Week 1, Month 2, Month 3, Month 9|NIH Toolbox Flanker Inhibitory Control and Attention Test (% Correct), This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the percent correct outcome from this assessment., Week 1, Month 2, Month 3, Month 9|NIH Toolbox Dimensional Change Card Sort Test (% Correct), This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the percent correct outcome from this assessment., Week 1, Month 2, Month 3, Month 9|NIH Toolbox Dimensional Change Card Sort Test (Omissions), This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the omissions outcome from this assessment., Week 1, Month 2, Month 3, Month 9|NIH Toolbox Dimensional Change Card Sort Test (RT), This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the response time (RT) outcome from this assessment., Week 1, Month 2, Month 3, Month 9|NIH Toolbox Dimensional Change Card Sort Test (IIV-RT), This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment., Week 1, Month 2, Month 3, Month 9|NIH Toolbox List Sorting Working Memory Test, This test serves as an evaluation of an individual's working memory capabilities. Participants will be presented with different stimuli visually and audibly, and they will be asked to recall and sequence them accordingly. The test takes approximately 7 minutes to complete., Week 1, Month 2, Month 3, Month 9|NIH Toolbox Pattern Comparison Processing Speed Test, This is an assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. The test takes approximately 4 minutes to complete., Week 1, Month 2, Month 3, Month 9
Secondary Outcome Measures: ADHD Rating Scale-5 (ADHD:RS-5) - Inattention Subscale, The investigators will assess the symptoms of ADHD by utilizing the parent and teacher ADHD Rating Scale-5 (ADHD:RS-5) Inattention Subscale, using two academic teachers and one parent for each participant. This 9-item subscale is specifically designed to evaluate the core ADHD symptoms of Inattention. By incorporating the perspectives of both teachers and parents, the investigators aim to obtain a comprehensive understanding of the participants' ADHD symptoms across settings. ADHD:RS-5: will be completed by prior school year teachers if the student has been in the class for less than 2 months. Higher scores represent a higher frequency of symptoms and this a worse outcome. For each item, "0" is the minimum and "3" is the maximum value., Week 1, Month 2, Month 3, Month 9|ADHD Rating Scale-5 (ADHD:RS-5) - Impulsivity/Hyperactivity Subscale, The investigators will assess the symptoms of ADHD by utilizing the parent and teacher ADHD Rating Scale-5 (ADHD:RS-5) Impulsivity/Hyperactivity Subscale, using two academic teachers and one parent for each participant. This 9-item subscale is specifically designed to evaluate the core ADHD symptoms of Impulsivity/Hyperactivity. By incorporating the perspectives of both teachers and parents, the investigators aim to obtain a comprehensive understanding of the participants' ADHD symptoms across settings. ADHD:RS-5: will be completed by prior school year teachers if the student has been in the class for less than 2 months. Higher scores represent a higher frequency of symptoms and this a worse outcome. For each item, "0" is the minimum and "3" is the maximum value., Week 1, Month 2, Month 3, Month 9|Academic Performance Rating Scale (APRS), The 19-item Academic Performance Rating Scale (APRS; DuPaul et al.,1991) evaluates student academic performance and is ecologically valid due to (1) assessing in real classroom environments, mirroring academic challenges and behaviors, (2) evaluated by teachers who gain insights into students' academic performance beyond standard tests, and (3) encompassing aspects of academic abilities including behavior, productivity, and work accuracy. This scale has a high test-retest reliability (2-week test-retest=.93-.95; α=.94-.95). Higher scores indicate better academic functioning and impulse control in school. For each item, "1" is the minimum and "5" is the maximum value., Week 1, Month 2, Month 3, Month 9