Compares ADHD medicines in children and teens with autism
Tests two stimulant medicines and an alpha-2 agonist for ADHD in children with autism.
Plain-language title generated from the registry record
Registry title: AWARE: Management of ADHD in Autism Spectrum Disorder
Key facts
- Where
- Boston, Charlottesville, Cincinnati, Columbus, Greenville, Irvine, Los Angeles, Philadelphia, Pittsburgh, Portland, and Rochester, United StatesSee the 11 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 17 years old?
Source: NCT05916339, who can take part
Where in United States
- Massachusetts General Hospital Lurie Center for AutismBoston, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- Nationwide Children's HospitalColumbus, United StatesTaking people
- Prisma Health-UpstateGreenville, United StatesTaking people
- University of California, IrvineIrvine, United StatesTaking people
- Children's Hospital Los AngelesLos Angeles, United StatesTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
- University of PittsburghPittsburgh, United StatesTaking people
- Maine Medical CenterPortland, United StatesTaking people
- University of RochesterRochester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daniel Coury
- Trial code
- NCT05916339
- Record updated
- 22 October 2026
- Original 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. 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.Read full original descriptionShow less
Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
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.
Inclusion: 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.
Exclusion: 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.