Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate

Timothy E. Wilens, Stephen V. Faraone, Paul G. Hammerness, Steven R. Pliszka, Cassandra L. Uchida, Norberto J. DeSousa, Floyd R. Sallee, Bev Incledon, Jeffrey H. Newcorn

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior–Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful. Method: Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression–Improvement (CGI-I) = 1 and CGI-I ≤ 2. Percentages of participants achieving these thresholds were calculated. Results: Thresholds for CGI-I = 1/CGI-I ≤ 2, respectively, were 27/20 (BSFQ), 5/3 (PREMB-R AM), and 9/5 (PREMB-R PM)-point decreases. More children achieved clinically meaningful improvements with DR/ER-MPH versus placebo (all p <.05). Conclusion: DR/ER-MPH increased proportions of children achieving clinically meaningful improvements in BSFQ and PREMB-R.

Original languageEnglish (US)
JournalJournal of Attention Disorders
DOIs
StateAccepted/In press - 2021

Keywords

  • ADHD
  • BSFQ
  • functional impairment
  • methylphenidate
  • PREMB-R

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Clinical Psychology

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