AWARE: Management of ADHD in Autism Spectrum Disorder (NCT05916339)
Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, Irvine — Irvine, California
Age range: 4 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- University of California, Irvine — Irvine, California
- Children's Hospital Los Angeles — Los Angeles, California
- Maine Medical Center — Portland, Maine
- Massachusetts General Hospital Lurie Center for Autism — Boston, Massachusetts
- University of Rochester — Rochester, New York
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania
- University of Virginia — Charlottesville, Virginia
- University of Alberta, Glenrose Rehabilitation Hospital — Edmonton,
- Holland Bloorview Kids Rehabilitation Hospital — Toronto,
📞 Contact the Study Coordinator
Phone: (614) 722-4006
Email: Amanda.James@nationwidechildrens.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.