NCT05916339 · Daniel Coury
AWARE: Management of ADHD in Autism Spectrum Disorder
What this study 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.
View original scientific description
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.
Interventions
DRUG
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid)
DRUG
Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
If first line stimulant therapy (Amphetamine/Methylphenidate) is deemed not effective or tolerable, re-randomization to the alternate stimulant or alpha-2 agonist will occur. If participant is satisfied with first line stimulant treatment, first-line stimulant therapy will continue. Catapres, Clonidine, Guanfacine, Intuniv, Kapvay, Tenex
Primary outcome measures
The Vanderbilt Parent Rating Scale
Time frame: 16 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study. 2. Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements. 3. Participant must be between 4 and 17 years of age (inclusive) at time of enrollment. 4. Participant must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS or CARS, etc.). 5. Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid). 6. Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence). 7. Participant must have a consistent reporter (e.g., parent) who spends regular time with the child. 8. Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvuls
Where
- Irvine, California
- Los Angeles, California
- Portland, Maine
- Boston, Massachusetts
- Rochester, New York
- Cincinnati, Ohio
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Charlottesville, Virginia
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
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations