Clinical trial NCT01772485: Online Neuroplasticity Training for Remediation of ADHD in Adolescent Children (ONTRAC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2013-01-21
Enrollment: 31
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ADHD rating scale IV change from baseline
timeFrame: 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 outcomes:
measure: CGIC change from baseline
timeFrame: Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention
Other outcomes:
measure: Test of Variables of Attention (TOVA), visual form, change from baseline
timeFrame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention.
measure: Spatial Sternberg Task change from baseline
timeFrame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention
measure: Verbal Sternberg Task change from baseline
timeFrame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention
measure: Stroop task change from baseline
timeFrame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: University of California, San Francisco
name: Jyoti Mishra, PhD
role: PRINCIPAL_INVESTIGATOR
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