Comparing medications for ADHD in children with autism
Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
PHASE4 · Nationwide Children's Hospital · NCT05916339
This study is testing two ADHD medications to see which works better for children with autism and how parents can help track their effectiveness.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital (other) |
| Locations | 12 sites (Irvine, California and 11 other locations) |
| Trial ID | NCT05916339 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 4 to 17 with confirmed diagnoses of both autism spectrum disorder and ADHD.
Not a fit: Patients who do not have a diagnosis of ADHD or autism spectrum disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective medication management for children with ADHD and autism, improving their overall quality of life.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific combination of ADHD medications in ASD patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Irvine, California and 11 other locations
- 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)
- Nationwide Children's Hospital — Columbus, Ohio, United States (RECRUITING)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
- University of Alberta, Glenrose Rehabilitation Hospital — Edmonton, Canada (RECRUITING)
- Holland Bloorview Kids Rehabilitation Hospital — Toronto, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ADHD, Autism Spectrum Disorder, Autism, ASD