Recruiting

ADHD Management

Sponsor:

Daniel Coury

Code:

NCT05916339

Conditions

ADHD

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication

Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.

Study Details

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.

Conditions

ADHD

Autism Spectrum Disorder

Study ID

NCT05916339

Start date

Oct 1, 2023

Status verified date

Oct, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Stage 1 - Stimulant

This proposed naturalistic, pragmatic clinical trial does not involve investigational drugs. Sequential, multiple assignment randomized trial (SMART) pragmatic clinical trial.

Stage 1 - randomization to either Amphetamine (AMP) or Methylphenidate (MPH). The specific medication prescribed by the physician will be determined by discussion between physician and parent / caregiver and review of the subject's insurance coverage. Subjects will receive their medication from their pharmacy.

active comparator: Stage 2 - Alpha-2 Agonist or Alternate Stimulant

Stage 2 - randomization to either Alpha-2 Agonist or other stimulant not randomized to in Stage 1: Amphetamine (AMP) or Methylphenidate (MPH).

(frequency, dosage, format, and duration dependent on participant and study doctor discussion).

Interventions

Randomization 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)

Randomization 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

Primary outcome measure

  • The Vanderbilt Parent Rating Scale [ Time Frame: 16 Weeks ]

Central Contacts and Locations

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Principal Investigator:

Peter Chung, MD

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Principal Investigator:

Kathryn Smith, RN, MN, DrPH

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Principal Investigator:

Danielle Sipsock, MD

Massachusetts General Hospital Lurie Center for Autism

Recruiting

Boston, Massachusetts, United States, 02421

Contacts

Alexander Cordova

acordova1@mgh.harvard.edu

Principal Investigator:

Ann Neumeyer, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Lynn Cole, DNP

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Julia Anixt, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Principal Investigator:

Eric Butter, PhD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19178

Contacts

Danielle Collins

collinsd2@chop.edu

Principal Investigator:

Carlyn Glatts, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15262

Contacts

Sarah McAuliffe-Bellin

412-235-5447mcausj@upmc.edu

Principal Investigator:

Benjamin Handen

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Susie Hoffman

SRH@uvahealth.org

Principal Investigator:

Richard Stevenson, MD

University of Alberta, Glenrose Rehabilitation Hospital

Recruiting

Edmonton, Canada

Contacts

Principal Investigator:

Lonnie Zwaigenbaum, MD

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Canada

Contacts

Principal Investigator:

Danielle Baribeau, MD, PhD

More Information

Sponsor

Daniel Coury

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • ADHD
  • Autism
  • ASD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Daniel Coury on 2025-10-29.