Comparing medications for ADHD in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial examines the effectiveness of two stimulant medications, methylphenidate and amphetamine, in treating ADHD in children and adolescents diagnosed with autism spectrum disorder (ASD). Utilizing a sequential, multiple assignment randomization trial (SMART) design, the study also explores the role of alpha-2 agonists in medication management. The goal is to enhance clinicians' understanding of medication options and improve treatment outcomes for patients with co-occurring ADHD and ASD. Parents will play an active role in assessing medication effectiveness and guiding adjustments based on their observations and discussions with healthcare providers.

Why it matters

Who can join: the full rules

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 medication (via pill, liquid or mixed with food/liquid).
6. Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence).
7. Participant must have a consistent reporter (e.g., parent) who spends regular time with the child.
8. 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.
9. 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.
10. Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.

Exclusion Criteria:

1. Participant has taken ADHD medication within the past 7 days.
2. Participant is not stable on other medications (\< 4 weeks).
3. 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.

Where it's running

• University of California, Irvine
  Irvine, California, United States Recruiting
• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Maine Medical Center
  Portland, Maine, United States Recruiting
• Massachusetts General Hospital Lurie Center for Autism
  Boston, Massachusetts, United States Recruiting
• University of Rochester
  Rochester, New York, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Daniel Coury, MD — Nationwide Children's Hospital
• Study coordinator: Amanda James, BS
• Email: Amanda.James@nationwidechildrens.org
• Phone: (614) 722-4006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.