AWARE: Management of ADHD in Autism Spectrum Disorder

Conditions

• ADHD
• Autism Spectrum Disorder

Eligibility Criteria

Sex

ALL

Age

4 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication — DRUG
  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. — DRUG
  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 Details

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.

Key Dates

Start date

Oct 1, 2023

Status verified

Oct 2025

Primary completion

Jan 1, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• 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).

Primary Outcome Measure

The Vanderbilt Parent Rating Scale [ Time Frame: 16 Weeks ]

Central Contacts

• Amanda James, BS
  (614) 722-4006
  [email protected]
• Samantha Sharpe
  (614) 722-8509
  [email protected]

Locations (10)

Find similar trials in Irvine, CA

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