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Ethical Considerations and Lessons Learned in a Randomized Controlled Trial of ThinkRx Cognitive Training for Children With Learning Disabilities and/or ADHD

By: & Published: 2020 | Product: SAGE Research Methods Cases: Medicine and Health
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In a randomized controlled trial, we examined the efficacy of 60 hr of ThinkRx, a clinician-delivered cognitive training program delivered to children with learning disabilities and/or ADHD. In this case review, we discuss the ethical considerations for using a waitlist control group instead of a sham intervention in lengthy behavioral interventions with a vulnerable population. We describe the control group options we considered and why we selected waitlist controls. We also discuss lessons we learned in the sampling and assessment stages of our study, including providing clarity in exclusionary criteria, testing technology equipment and Internet access, optimal scheduling, and verifying the validity of testing measures with our specific population. We report our quantitative and qualitative outcomes from two articles published on this study including statistically significant differences in eight of the nine measures, clinically significant changes in IQ score for the ADHD subset, and parent-reported improvements in self-esteem, self-discipline, cooperative behaviors, and school performance.

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