AWARE: Management of ADHD in Autism Spectrum Disorder

ClinicalTrials.gov ID: NCT05916339

Public ClinicalTrials.gov record NCT05916339. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 28, 2026, 5:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05916339
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 4
Lead sponsor: Daniel Coury; Other
Enrollment: 500 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 4 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 30, 2023
Primary completion: Dec 31, 2026
Completion: Dec 29, 2027
Last update posted: Oct 28, 2025

2023 – 2027

United States locations

U.S. sites: 10
U.S. states: 7
U.S. cities: 10

Facility	City	State	ZIP	Site status
University of California, Irvine	Irvine	California	92697	Recruiting
Children's Hospital Los Angeles	Los Angeles	California	90027	Recruiting
Maine Medical Center	Portland	Maine	04102	Recruiting
Massachusetts General Hospital Lurie Center for Autism	Boston	Massachusetts	02421	Recruiting
University of Rochester	Rochester	New York	14642	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	43205	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19178	Recruiting
University of Pittsburgh	Pittsburgh	Pennsylvania	15262	Recruiting
University of Virginia	Charlottesville	Virginia	22903	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05916339, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 28, 2025 · Synced Jul 28, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05916339 live on ClinicalTrials.gov.

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