NeuroTrainer Cognitive Training For Academic Focus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorNeuroTrainer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnostic criteria met ADHD for any ADHD presentation type, with severity ratings of subthreshold, moderate or severe

Estimated IQ of 80 or greater

Between 11-17 years of age

Disqualifiers

Presence of suicidality

Presence of psychotic disorders

Visual or hearing impairment

Presence of severe depression

Trial design

Design model

Parallel

Treatments tested in this trial

  • NeuroTrainer

    Behavioral

    Virtual reality based cognitive training

Treatment groups

155 Participants
are divided into 2 treatment groups
Group A: NeuroTrainer InterventionExperimental treatment 1 intervention
Group B: Control ConditionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 1, Month 2, Month 3, Month 9
2

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.

Time frame
Week 1, Month 2, Month 3, Month 9
3

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.

Time frame
Week 1, Month 2, Month 3, Month 9
4

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.

Time frame
Week 1, Month 2, Month 3, Month 9

Secondary outcomes

1

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.

Time frame
Week 1, Month 2, Month 3, Month 9
2

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.

Time frame
Week 1, Month 2, Month 3, Month 9
3

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.

Time frame
Week 1, Month 2, Month 3, Month 9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NeuroTrainer

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

University of California, Davis

Collaborator