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

What this Trial Is About

Researchers are evaluating the comparative effectiveness of two stimulant medications, methylphenidate and amphetamine, in treating ADHD in children and adolescents with autism spectrum disorder (ASD). This pragmatic clinical trial also examines the role of alpha-2 agonist medications for those who do not respond to first-line stimulant treatments. The goal is to improve medication selection and reduce repeated trials of multiple medications, which are common in current care practices for this population. Participants will be randomly assigned in a two-stage process. In the first stage, children will receive either an amphetamine or methylphenidate medication, chosen through discussion between the physician and parent and considering insurance coverage. If the first-line stimulant is not effective or tolerable, the second stage involves randomization to either an alpha-2 agonist medication or the alternate stimulant. The dose, frequency, and duration of medications are tailored through ongoing discussions between the participant, family, and study doctor. Throughout the study, parents will regularly provide ratings on their child's symptoms and behaviors using tools such as the Vanderbilt Parent Rating Scale, Clinical Global Impression, and Aberrant Behavior Checklist. These assessments will mostly be completed electronically, minimizing the need for hospital visits. The study team will monitor medication effectiveness, side effects, and parent observations to guide treatment decisions. Participation lasts at least 16 weeks, during which safety and symptom management are closely followed to develop best practices for ADHD treatment in children with ASD.

AWARE: Management of ADHD in Autism Spectrum Disorder