Phase II year
2019
(last award dollars: 2022)
Phase II Amount
$3,598,859
ADHD is a highly prevalent disorder that creates significant professional, social and personal difficulties for the patients - there is a real need for additional, non-pharmacological treatments. The target of our product is inconsistent control of sustained attention, an important remediation target for ADHD with major real-life impact. Sustained attention is related to symptom severity and correlated with real-life functions such as reading, listening, driving and work safety. Sustained attention measures and inattention symptoms in ADHD have also been correlated with academic achievement. Our Sustained Attention Control (SAC) teaching approach is quite different from brain training methods and uses an innovative (patented) approach based on models and evidence-based studies of experiential learning. It includes 6 essential teaching factors, identified in the literature for promoting meaningful learning and transfer, that differentiate us from existing products (Table 1, Commercialization Plan). Better transfer can occur when a conceptual understanding of attentional control, self-awareness and metacognitive skills are developed. In a previous Phase-I project we built a prototype of our SAC teaching mobile-software and tested it in a full RCT, double-blind, active control, study (n=63). We found significantly greater improvements in the SAC group than the active Control group on both primary outcome measures: a sustained attention measure (Conners CPT RT Variability), and time-limited reading comprehension (Nelson-Denny Reading Test), demonstrating far transfer to a standardized test of an important real-life activity impaired in adults with ADHD. Based on exit interviews from that study we conducted additional design work and extensive customer research that revealed that adults with ADHD need an additional step of training that develops metacognitive skills for applying their attentional awareness to daily life. In answer to this need, we designed the Learning-To-Transfer module (Phase-I of this Fast Track) with the expectation that, when integrated with SAC (Phase-II of this Fast Track), it will amplify our prior far transfer results. The exit interviews also identified areas for improvement of the SAC modules related to UX and motivation/adherence to be built in Phase-II. We will: PHASE-I:Aim-1: Build and test the Learning-To-Transfer (LTT) module, a complex attentive listening task simulating daily life listening challenges, with performance feedback. PHASE-II: Aim-2: Integrate LTT into the SAC teaching program. Build software tools to improve UX ease of use; add a training exercise and increase skins for variety; improve difficulty leveling; add new prescriptive tool for reflection and applications of learning to daily-life activities. PHASE-II: Aim-3: Test the efficacy of fully integrated prototype (expanded SAC+LTT) with a RCT, double-blind, active control study with 140 participants, using an Intention-To-Treat design, with outcome measures for far transfer [Nelson Denny Reading Comprehension; STISIM Driving Simulator test; Woodcock-Johnson Oral Comprehension; BAARS-IV Symptoms].
Public Health Relevance Statement: Narrative. Attention-Deficit/Hyperactivity Disorder (ADHD) is a highly prevalent disorder incurring billions of dollars of economic impact annually and treated primarily by pharmacological methods. There is a real need for additional, non-pharmacological treatments. This project is aimed at demonstrating the efficacy of an innovative new product that uses mobile apps and web-based tools to improve attentional control in adults with ADHD.
NIH Spending Category: Attention Deficit Disorder (ADD); Basic Behavioral and Social Science; Behavioral and Social Science; Brain Disorders; Clinical Research; Clinical Trials and Supportive Activities; Mental Health
Project Terms: Academic achievement; active control; Active Learning; Address; Adherence; Adult; Android; Area; Attention; Attention deficit hyperactivity disorder; attentional control; Automobile Driving; Awareness; base; Blinded; Brain; Clinic; Clinical; Code; Cognitive; commercialization; Complex; Comprehension; comprehension test; Computer software; Computers; Conduct Clinical Trials; Consumption; Control Groups; design; Development; Disease; Double-Blind Method; economic impact; Educational process of instructing; efficacy testing; Elements; evidence base; Exercise; expectation; Feedback; Foundations; Impairment; improved; inattention; informant; innovation; Intention; Intervention; Interview; Learning; Legal patent; Life; Literature; Measures; Methods; mobile application; Modeling; Motivation; off-patent; Oral; Outcome Measure; Participant; Patients; Performance; Pharmacology; Phase; primary outcome; product development; programs; prototype; Proxy; Psychological Transfer; Randomized; Reading; reading comprehension; remediation; Research; Safety; Self Perception; Severities; skills; Skin; social; Software Tools; Specific qualifier value; Standardization; Step training; Stimulus; Structure; sustained attention; Symptoms; Testing; Therapeutic; Time; tool; Training; usability; Volition; web-based tool; Work
