AWARE: Management of ADHD in Autism Spectrum Disorder

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

Interventions

DRUG

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)

DRUG

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

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• Holland Bloorview Kids Rehabilitation Hospital

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• MaineHealth

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Daniel Coury

  lead OTHER

Principal Investigators

• Daniel Coury, MD · Nationwide Children's Hospital

• Karen Kuhlthau, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2027-01-01

Completion

2027-12-30

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations