Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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This study evaluates the impact of computerized inhibitory control training on attention-deficit hyperactivity disorder (ADHD) symptoms and ADHD-linked neural signatures in children with ADHD. Children were randomly assigned to adaptive computerized training (n=20) or non-adaptive computerized training control (n=20) with identical stimuli and goals.

Detailed Description
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Both medication and cognitive behavioral therapy are effective treatments for many children, however, adherence to both medication and therapy regimes is low. Thus, identifying effective adjunct treatments for ADHD is imperative. Previous studies exploring computerized training programs as supplementary treatments have targeted working memory or attention. However, many lines of research point to inhibitory control (IC) playing a central role in ADHD pathophysiology. IC abnormalities in children with ADHD have been evidenced both in behavioral performance on computerized tasks as well as in the structure and function of neural systems known to support IC function. Furthermore, these IC abnormalities have been linked to symptom severity. Given findings that the most successful training interventions for children with ADHD are those that have implemented IC training along wtih working memory or attention and previous work demonstrating that IC is a central deficit for children with ADHD, it is surprising that no studies have sought to investigate programs that specifically target IC. Investigators hypothesize that training IC alone will decrease symptoms of ADHD, and information confirming this hypothesis would contribute to making training regimens for children with ADHD efficient by identifying the primary cognitive skill that requires intervention. To test this, they administer a randomized control trial of either adaptive of non-adaptive stop signal reaction time (SSRT) tasks to children with ADHD and assess effects of training on ADHD symptoms and neural activity.

Official Title
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Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Adaptive Inhibitory Control Training
* Behavioral: Non-adaptive Inhibitory Control Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of inattentive or combined subtype ADHD by a licensed clinician and consistent acess to Wi-Fi at home. Exclusion Criteria: Any known genetic abnormalities, a diagnosis of autism spectrum disorder, or current use of medication for psychiatric disorders other than ADHD (e.g. depression, anxiety).

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children were randomly assigned to adaptive treatment (n=20) or non-adaptive control (n=20) with identical tasks, stimuli, and goals. Children were instructed to train for 5 days a week (25m/day) for 4-weeks. All participants had between 10-20 training sessions at study completion.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptive Inhibitory Control Training<br>Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition involved real-time adaptive gameplay that increased in difficulty as performance increased. | Behavioral: Adaptive Inhibitory Control Training<br>* Playing computerized stop-signal reaction time tasks that had been modified to increase in difficulty as performance increased.<br>|
| Active Comparator: Non-Adaptive Inhibitory Control Training<br>Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition had no change in difficulty (non-adaptive gameplay). | Behavioral: Non-adaptive Inhibitory Control Training<br>* Playing computerized stop-signal reactions time tasks that do not change in difficulty level (non-adaptive).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Parent-Reported Inattention Symptoms | Parent-report of inattention symptoms using the Swanson, Nolan, and Pelham Questionnaire (SNAP-IV). The SNAP-IV is based on a 0 to 3 rating scale (Not at All = 0, Just A Little = 1, Quite a Bit = 2, and Very Much = 3). Subscale inattention items are calculated by summing the score for the 9 inattention items and dividing by 9. | Baseline and 4-weeks | 
| Change in Average Parent-Reported Hyperactivity Symptoms | Parent-report of hyperactivity symptoms used the Swanson, Nolan, and Pelham Questionnaire (SNAP-IV). The SNAP-IV is based on a 0 to 3 rating scale (Not at All = 0, Just A Little = 1, Quite a Bit = 2, and Very Much = 3). Subscale hyperactivity items are calculated by summing the score for the 9 hyperactivity items and dividing by 9. | Baseline and 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Relative Theta Power During Resting-State Electroencephalogram(EEG) Recording | EEG data was collected for both eyes open and eyes closed resting state for 7 trials of 30 seconds each. For each participant, relative power in the theta band (5-8 Hz) was calculated for two regions of interest analogous to bilateral parietal electrodes in the international 10-10 system using frequency band analyses. | Baseline and 4-weeks | 
| Change in Teacher Reported Inattention | Teachers or other non-parental caretakers (e.g. babysitter) completed the teacher report versions of the Conners. The Conner's is based on a 0 to 3 rating scale with 0 being Not true at all, 1 = Just a little true, 2 = pretty much true, and 3 = Very much true. The teacher-report inattention score was calculated by norming and averaging ratings of the inattention domains in the Conner's Teacher Report. | Baseline and 4-weeks | 
| Change in Teacher Reported Hyperactivity | Teachers or other non-parental caretakers (e.g. babysitter) completed the teacher report versions of the Conners. The Conner's is based on a 0 to 3 rating scale with 0 being Not true at all, 1 = Just a little true, 2 = pretty much true, and 3 = Very much true. The teacher-report hyperactivity score was calculated by norming and averaging ratings of the hyperactivity domains in the Conner's Teacher Report. | Baseline and 4-weeks | 
| Change in N200 Event-Related Potential (ERP) Component During Inhibition | The N200 is a negative going component maximal over frontal scalp cites, which peaks roughly between 200 and 350 ms post stimulus onset. Each subject's ERP response on both errors of commission and correct inhibition trials of a stop-signal reaction time task were analyzed for changes in amplitude and latency. | Baseline and 4-weeks |