NCT05916339RecruitingPhase 4
AWARE: Management of ADHD in Autism Spectrum Disorder
Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 31 May 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Daniel Coury
- Diseases
- Autism
- NCT number
- NCT05916339
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 500
- From 1 Oct 2023 to the primary completion date, 1 Jan 2027
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has taken ADHD medication within the past 7 days.
- Participant is not stable on other medications (\< 4 weeks).
- Any other risk factor that might prevent patient from safely taking the study medications.
- There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire IQ range.
Who the study is looking for
- Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.
- Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements.
- Participant must be between 4 and 17 years of age (inclusive) at time of enrollment.
- 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.).
- Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid).
- Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence).
- Participant must have a consistent reporter (e.g., parent) who spends regular time with the child.
- Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for \> 4 weeks prior to consent with no plans for a dose change during the study.
- It has been at least 7 days since the participant last took an ADHD medication and the presiding clinician believes this to be a sufficient amount of time.
- Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.
Age in the registry: 4 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta, Glenrose Rehabilitation Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Holland Bloorview Kids Rehabilitation Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Massachusetts General Hospital Lurie Center for Autism Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Prisma Health-Upstate Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Maine Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.