Management of ADHD in Autism Spectrum Disorder
ADHD, Autism Spectrum Disorder
About this trial
This is an interventional health services research trial for ADHD focused on measuring ADHD, Autism, ASD
Eligibility Criteria
Inclusion Criteria: Patient and/or legally authorized representative must be willing and able to give informed consent/assent for participation in this study. Patient and their caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements. Patient must be between 4 and 17 years of age (inclusive) at time of enrollment. Patient must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS (Autism Diagnostic Observation Schedule) or CARS (Childhood Autism Rating Scale), etc.). Patient must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid). Patient must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence). Patient must have a consistent reporter (e.g., parent) who spends regular time with the child. Patient 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. Patient with prior trial of ADHD medication more than one year before enrollment, based on clinician judgement of reason for prior trial failure. Patient and/or family/caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study. Exclusion Criteria: Patient history of more than one prior trial of an ADHD medication within the past year. Less than 4 weeks since last ADHD medication was taken. 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.
Sites / Locations
- University of California, Irvine
- Children's Hospital Los Angeles
- Maine Medical Center
- Massachusetts General Hospital Lurie Center for Autism
- University of Rochester
- Cincinnati Children's Hospital Medical Center
- Nationwide Children's Hospital
- Children's Hospital of Philadelphia
- University of Pittsburgh
- University of Virginia
- University of Alberta, Glenrose Rehabilitation Hospital
- Holland Bloorview Kids Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Stage 1 - Stimulant
Stage 2 - Alpha-2 Agonist or Alternate Stimulant
This proposed naturalistic, pragmatic clinical trial does not involve investigational drugs. Sequential, multiple assignment randomized trial (SMART) pragmatic clinical trial. Stage 1 - randomization to either Amphetamine (AMP) or Methylphenidate (MPH). The specific medication prescribed by the physician will be determined by discussion between physician and parent / caregiver and review of the subject's insurance coverage. Subjects will receive their medication from their pharmacy.
Stage 2 - randomization to either Alpha-2 Agonist or other stimulant not randomized to in Stage 1: Amphetamine (AMP) or Methylphenidate (MPH). (frequency, dosage, format, and duration dependent on participant and study doctor discussion).