AWARE: Management of ADHD in Autism Spectrum Disorder

NCT05916339 · tracked via the Priya Life Science Canada tracker

Sponsor

Daniel Coury

Phase

Phase 4

Started

2023-10-01

Last updated

2025-10-29

Condition(s) studied

ADHDAutism Spectrum Disorder

Investigational drug(s) / intervention(s)

Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medicationRandomization to either Alpha 2 agonist class of medication or alternate class of stimulant.

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)

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

Study 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

Sex

ALL

Min age

4 Years

Max age

17 Years

Healthy volunteers

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.

Primary outcome measure(s)

The Vanderbilt Parent Rating Scale — 16 Weeks
The primary outcome measure is The Vanderbilt Parent Rating Scale for ADHD consists of 18 item, each scored from 0 to 3. It has a minimum score of 0, maximum score of 54. Higher scores indicate worse outcome.

Trial sites (12)

Facility	City	Region	Status
University of California, Irvine	Irvine	California	Recruiting
Children's Hospital Los Angeles	Los Angeles	California	Recruiting
Maine Medical Center	Portland	Maine	Recruiting
Massachusetts General Hospital Lurie Center for Autism	Boston	Massachusetts	Recruiting
University of Rochester	Rochester	New York	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	Recruiting
University of Pittsburgh	Pittsburgh	Pennsylvania	Recruiting
University of Virginia	Charlottesville	Virginia	Recruiting
University of Alberta, Glenrose Rehabilitation Hospital	Edmonton	Canada	Recruiting
Holland Bloorview Kids Rehabilitation Hospital	Toronto	Canada	Recruiting

Other trials for the same condition

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Recruiting

Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach) Recruiting

Psilocybin for Treatment-Resistant Depression in Autism Active, not recruiting

Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study Starting soon

rTMS for Depression in Young Adults With Autism Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05916339 on ClinicalTrials.gov ↗ ← All trials in Canada