AWARE: Management of ADHD in Autism Spectrum Disorder

Recruiting now · Phase 4

Conditions studied: ADHD, Autism Spectrum Disorder

In brief

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.

Key facts

Study ID: NCT05916339
Run by: Daniel Coury
People needed: 500
Starts: 2023-10-01
Expected to finish: 2027-12-30
Last updated by the study team: 2025-10-29

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of California, Irvine — Irvine, California, United States (enrolling)
Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
Maine Medical Center — Portland, Maine, United States (enrolling)
Massachusetts General Hospital Lurie Center for Autism — Boston, Massachusetts, United States (enrolling)
University of Rochester — Rochester, New York, United States (enrolling)
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
University of Virginia — Charlottesville, Virginia, United States (enrolling)
University of Alberta, Glenrose Rehabilitation Hospital — Edmonton, Canada (enrolling)
Holland Bloorview Kids Rehabilitation Hospital — Toronto, Canada (enrolling)

Full record on ClinicalTrials.gov

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