Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
Daniel Coury
Summary
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.
Description
Current data shows that 1 in 54 children in the United States are diagnosed with autism spectrum disorder (ASD). Additional data shows that those diagnosed with autism are also at risk for being diagnosed with a co-occurring condition such as attention deficit/hyperactivity disorder (ADHD). Managing the symptoms of each can be challenging for providers, patients, and parents. Patients with ASD who are diagnosed with ADHD often face the challenge of finding the best medication options to treat symptoms. It is known that children with ASD and ADHD frequently respond differently to these treatme…
Eligibility
- Age range
- 4–17 years
- Sex
- All
- Healthy volunteers
- No
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 medica…
Interventions
- DrugRandomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid)
- DrugRandomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
If first line stimulant therapy (Amphetamine/Methylphenidate) is deemed not effective or tolerable, re-randomization to the alternate stimulant or alpha-2 agonist will occur. If participant is satisfied with first line stimulant treatment, first-line stimulant therapy will continue. Catapres, Clonidine, Guanfacine, Intuniv, Kapvay, Tenex
Locations (12)
- University of California, IrvineIrvine, California
- Children's Hospital Los AngelesLos Angeles, California
- Maine Medical CenterPortland, Maine
- Massachusetts General Hospital Lurie Center for AutismBoston, Massachusetts
- University of RochesterRochester, New York
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio