AWARE: Managing ADHD in Autism Spectrum Disorder
This study, called AWARE, is looking at the best ways to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and teenagers who also have Autism Spectrum Disorder (ASD). Researchers want to compare two common types of stimulant medications: Amphetamine (like Adderall, Mydayis) and Methylphenidate (like Concerta, Focalin). If these don't work well, participants might try the other stimulant or an Alpha 2 agonist medication. The study will enroll about 500 children aged 4 to 17. Success will be measured by changes in ADHD symptoms, as reported by parents using the Vanderbilt Parent Rating Scale after 16 weeks. The study's current status is unclear.
- Study design
- This is an interventional study that will enroll about 500 participants. Participants will be randomly assigned to receive either an Amphetamine or Methylphenidate medication.
- What's involved
- Participants will have their ADHD symptoms measured using the Vanderbilt Parent Rating Scale at 16 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 16 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AWARE: Management of ADHD in Autism Spectrum Disorder
At a glance
Conditions
NCT05916339
Where you'd take part
This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Hospital Los Angeles
Los Angeles, Californiastudy coordinator listed
Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohiostudy coordinator listed
Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Canadastudy coordinator listed
Recruiting
Maine Medical Center
Portland, Mainestudy coordinator listed
Recruiting
Massachusetts General Hospital Lurie Center for Autism
Boston, Massachusettsstudy coordinator listed
Recruiting
Nationwide Children's Hospital
Columbus, Ohiostudy coordinator listed
Recruiting
University of Alberta, Glenrose Rehabilitation Hospital
Edmonton, Canadastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Daniel Coury, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital
- Karen Kuhlthau, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- The Vanderbilt Parent Rating Scale16 Weeks
The primary outcome measure is The Vanderbilt Parent Rating Scale for ADHD consists of 18 item, each scored from 0 to 3. It has a minimum score of 0, maximum score of 54. Higher scores indicate worse outcome.