AWARE: Management of ADHD in Autism Spectrum Disorder
Recruiting
Phase 4Interventional Study
ADHDAutism Spectrum Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
4 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Health Services Research
Participants needed
500 (estimated)
Sponsor
Daniel Coury · Other
Who this trial is looking for
This trial is looking for children and teenagers with ADHD and autism to compare two types of medication. Participants will take either methylphenidate or amphetamine and may also try another kind of ADHD medication.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 4 and 17 years old.
I have been diagnosed with autism spectrum disorder.
I have been diagnosed with ADHD.
I can take my medication consistently.
I have someone who can report on my behavior.
I or my caregiver can understand English or Spanish.
I have not taken ADHD medication in the last 7 days.
You may not be able to join if
I have taken ADHD medication in the past 7 days.
I am not stable on other medications.
I have a risk factor that may prevent me from safely taking the study medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 med…
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.
Trial Locations
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Status
Eligibility Criteria
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 mu…
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.
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