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.
• 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.