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AWARE: Management of ADHD in Autism Spectrum Disorder

RecruitingPhase 4

Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder

Who can join

Ages 4 to 17 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. 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, anticonvulsant) if dose has been stable for \> 4 weeks prior to consent with no plans for a dose change during the study.
9. 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.
10. Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.

Exclusion Criteria:

1. Participant has taken ADHD medication within the past 7 days.
2. Participant is not stable on other medications (\< 4 weeks).
3. 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.

About the study

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.

What is being tested

Sponsor: Daniel Coury · Participants: 500 · Started: Oct 1, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05916339

Locations in the U.S.

CaliforniaUniversity of California, Irvine, Irvine
Children's Hospital Los Angeles, Los Angeles
MaineMaine Medical Center, Portland
MassachusettsMassachusetts General Hospital Lurie Center for Autism, Boston
New YorkUniversity of Rochester, Rochester
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Nationwide Children's Hospital, Columbus
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
University of Pittsburgh, Pittsburgh
VirginiaUniversity of Virginia, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.