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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
View:

• Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.

• Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements.

• Participant must be between 4 and 17 years of age (inclusive) at time of enrollment.

• 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.).

• Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid).

• Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence).

• Participant must have a consistent reporter (e.g., parent) who spends regular time with the child.

• 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.

• 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.

⁃ Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.

Locations
United States
California
University of California, Irvine
RECRUITING
Irvine
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Massachusetts
Massachusetts General Hospital Lurie Center for Autism
RECRUITING
Boston
Maine
Maine Medical Center
RECRUITING
Portland
New York
University of Rochester
RECRUITING
Rochester
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
University of Pittsburgh
RECRUITING
Pittsburgh
Virginia
University of Virginia
RECRUITING
Charlottesville
Other Locations
Canada
University of Alberta, Glenrose Rehabilitation Hospital
RECRUITING
Edmonton
Holland Bloorview Kids Rehabilitation Hospital
RECRUITING
Toronto
Contact Information
Primary
Aria Dockham, MACPR
Aria.Dockham@nationwidechildrens.org
614-722-0723
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 500
Treatments
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).
Sponsors
Collaborators: University of Rochester, Nationwide Children's Hospital, MaineHealth, University of Michigan, University of California, Irvine, Children's Hospital Medical Center, Cincinnati, Massachusetts General Hospital, Children's Hospital of Philadelphia, University of Pittsburgh, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital Los Angeles, University of Alberta, University of Virginia, Patient-Centered Outcomes Research Institute
Leads: Daniel Coury

This content was sourced from clinicaltrials.gov