AWARE: Management of ADHD in Autism Spectrum Disorder

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.

NCT Number	NCT05916339
Lead Sponsor	Daniel Coury Collaborators: Patient-Centered Outcomes Research Institute, University of California, Irvine, Holland Bloorview Kids Rehabilitation Hospital, University of Rochester, Nationwide Children's Hospital, Children's Hospital Medical Center, Cincinnati, University of Virginia, University of Alberta, Massachusetts General Hospital, MaineHealth, University of Michigan, University of Pittsburgh, Children's Hospital of Philadelphia, Children's Hospital Los Angeles
Conditions	ADHD, Autism Spectrum Disorder
Enrollment	500 participants
Start Date	2023-10-01
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-10-29