NCT05916339 AWARE: Management of ADHD in Autism Spectrum Disorder
| NCT ID | NCT05916339 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Daniel Coury |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2023-10-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Daniel Coury, MD
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT05916339 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05916339 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05916339 currently recruiting?
Yes, NCT05916339 is actively recruiting participants. Contact the research team at Amanda.James@nationwidechildrens.org for enrollment information.
Where is the NCT05916339 trial being conducted?
This trial is being conducted at Irvine, United States, Los Angeles, United States, Portland, United States, Boston, United States and 9 additional locations.
Who is sponsoring the NCT05916339 clinical trial?
NCT05916339 is sponsored by Daniel Coury. The principal investigator is Daniel Coury, MD at Nationwide Children's Hospital. The trial plans to enroll 500 participants.