Online Neuroplasticity Training for Remediation of ADHD in Adolescent Children (ONTRAC)

Study Overview
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Brief Summary
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This project shall rigorously evaluate the effectiveness of a novel, neuroplasticity-based internet-deliverable cognitive training program, which specifically targets the treatment of core cognitive dysfunctions observed in adolescents with Attention Deficit Hyperactivity Disorder (ADHD/ADD), to be tested in a clinical population in New Delhi, India.

Detailed Description
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Children diagnosed with ADHD, now comprising nearly 9% of American children and a similar proportion of Indian children, are at risk for failure or drop out from school, prone to developing addictions, having driving accidents, committing felonies later in life and suffer from an overall poor quality of life. Rescuing the cognitive faculties of these children is thus of immediate importance, not only from the perspective of the individual, but also from the urgency posed by the large socio-economic and health-care burdens associated with this disorder. The investigators have recently developed an efficient, state-of-the-art, web-based, cost-effective and highly scalable cognitive training program for ADHD ('Rewired') that can translate into real-life functional gains for the affected children. The novel program targets the fundamental neurobehavioral/ cognitive deficits identified in this disorder. These include deficits in general alertness, selective attention and working memory of goal-relevant information, control of impulsive actions and suppression of distracting information - a panoply of problems that have not been comprehensively addressed by any intervention in this population to-date. Recent advances in neuroscientific research have provided key insight into the application of brain-based methods to behavioral training to drive substantial functional gains. This research forms the mechanistic basis of the development approach. Moreover, the principal exercise forms in the training program have independently demonstrated significant benefits in other attentionally-impaired populations towards remediation of the core cognitive deficits that intersect with the deficient domains in ADHD. Here, the core exercise forms have been tailored and elaborated into a comprehensive program suite of 26 engaging, performance-adaptive, and rewarding training modules that provide 30 hours of rigorous neuroplasticity-based cognitive training for children with ADHD. The investigators propose to validate the usability and feasibility of this novel training program in a randomized controlled trial (RCT) setting. It is hypothesized that improvements in the specific core cognitive domains deficient in ADHD, shall translate to better overall cognitive function in daily life as well as significant reduction of ADHD symptom severity. The current intervention ultimately projects a better life quality for children with ADHD, and has the potential to substantially reduce the large personal, familial, societal and economic burden associated with the disorder worldwide.

Official Title
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Double Blind Randomized Controlled Trial Evaluation of a Novel Brain Plasticity-based Training Program for the Remediation of Cognitive Deficits in Adolescents With ADHD in New Delhi, India

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Cognitive Training
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ADHD as verified by a semi-structured clinical interview using the Kiddie-SADS (Schedule for Affective Disorders and Schizophrenia) interview schedule for school-aged children and SWAN rating scale (Polderman et al., 2007) Access to an internet connected computer for online training Exclusion Criteria: Fulfilling criteria for diagnosis of clinically significant conduct disorder Autistic or Asperger's syndrome Depression History of seizure disorder or seizure episodes over the last 2 years Motor/ perceptual handicap that prevents computer use

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Training<br>Training group participants will engage in 30 hours of at-home online training on the novel neuroplasticity-based cognitive training program ('Rewired') in 30 minute sessions completed approximately 3-5 days per week, for a total training period lasting 12-20 weeks. Both visual and auditory exercise forms will be practiced daily. Level progression criteria will be flexibly set to assure that almost all individuals can reach them in a reasonable time. Training compliance and performance data (accuracies and reaction times) will be continuously monitored remotely, and analyzed over secure online servers to assure that subjects are completing their training as scheduled and to deal with any unexpected road-blocks in training. | Behavioral: Cognitive Training<br>* The training comprises a suite of 26 engaging, performance-adaptive, and rewarding training modules that provide 30 hours of rigorous neuroplasticity-based cognitive training for children with ADHD addressing deficits in core cognitive domains of alertness, selective attention and working memory of goal-relevant information, control of impulsive actions and suppression of distracting information.<br>|
| Active Comparator: Active Control<br>The active control group shall engage in an at-home computer game suite, as used in a prior cognitive training trial in a psychiatric population (Fisher et al., 2009), for the same number of hours as the training group to control for the effects of computer exposure and interaction, contact with clinical research personnel and monetary rewards. Compliance will be monitored via an online data portal. | Behavioral: Active Control<br>* Participants will engage in any 4 of 13 suite games (visual tiled puzzles, word games etc.) from the Hoyle Puzzle and Board games program. Suite games are randomly assigned in each session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD rating scale IV change from baseline |  | Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGIC change from baseline | Clinical Global Impressions of Change | Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention |