AWARE: Management of ADHD in Autism Spectrum Disorder

Description

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

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Study Overview

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Study Details

Study overview

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.

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

AWARE: Management of ADHD in Autism Spectrum Disorder

Condition
ADHD
Intervention / Treatment

-

Contacts and Locations

Irvine

University of California, Irvine, Irvine, California, United States, 92697

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Portland

Maine Medical Center, Portland, Maine, United States, 04102

Boston

Massachusetts General Hospital Lurie Center for Autism, Boston, Massachusetts, United States, 02421

Rochester

University of Rochester, Rochester, New York, United States, 14642

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19178

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15262

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

4 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Daniel Coury,

Daniel Coury, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Karen Kuhlthau, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2027-12-30