Actively Recruiting
AWARE: Management of ADHD in Autism Spectrum Disorder
Led by Daniel Coury ยท Updated on 2025-10-29
500
Participants Needed
12
Research Sites
221 weeks
Total Duration
On this page
Sponsors
D
Daniel Coury
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AWARE: Management of ADHD in Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legal caregiver can give informed consent or assent
- Participant or caregiver can follow all study requirements
- Participant is between 4 and 17 years old
- Participant has confirmed diagnosis of autism spectrum disorder based on medical records
- Participant can consistently take medication by pill, liquid, or mixed with food/liquid
- Participant has confirmed ADHD diagnosis based on DSM-5 criteria
- Participant has a consistent reporter (e.g., parent) who spends regular time with them
- Participant can be on stable doses of certain psychotropic medications for over 4 weeks
- Participant has not taken ADHD medication in the last 7 days
- Caregiver speaks English or Spanish well enough to complete study questionnaires
You will not qualify if you...
- Participant has taken ADHD medication within the past 7 days
- Participant is not stable on other medications (less than 4 weeks)
- Any other risk factor preventing safe use of study medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Maine Medical Center
Portland, Maine, United States, 04102
Actively Recruiting
4
Massachusetts General Hospital Lurie Center for Autism
Boston, Massachusetts, United States, 02421
Actively Recruiting
5
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19178
Actively Recruiting
9
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15262
Actively Recruiting
10
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
11
University of Alberta, Glenrose Rehabilitation Hospital
Edmonton, Canada
Actively Recruiting
12
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Canada
Actively Recruiting
Research Team
A
Amanda James, BS
CONTACT
S
Samantha Sharpe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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