RECRUITING

AWARE: Management of ADHD in Autism Spectrum Disorder

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Conditions

ADHDAutism Spectrum DisorderAutismASD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-01
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05916339

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.

Ages Eligible for Study:4 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.
  2. 2. Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements.
  3. 3. Participant must be between 4 and 17 years of age (inclusive) at time of enrollment.
  4. 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. 5. Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid).
  6. 6. Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence).
  7. 7. Participant must have a consistent reporter (e.g., parent) who spends regular time with the child.
  8. 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. 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. 10. Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.
  1. 1. Participant has taken ADHD medication within the past 7 days.
  2. 2. Participant is not stable on other medications (\< 4 weeks).
  3. 3. Any other risk factor that might prevent patient from safely taking the study medications.
  4. * 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.

Contacts and Locations

Study Contact

Aria Dockham, MACPR
CONTACT
614-722-0723
Aria.Dockham@nationwidechildrens.org

Principal Investigator

Daniel Coury, MD
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Karen Kuhlthau, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Daniel Coury

  • Daniel Coury, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital
  • Karen Kuhlthau, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • ADHD
  • Autism
  • ASD

Additional Relevant MeSH Terms

  • ADHD
  • Autism Spectrum Disorder