Treating Young Children With Attention Deficit Hyperactivity Disorder

Conditions

• Attention-Deficit/Hyperactivity Disorder (ADHD)

Eligibility Criteria

Sex

ALL

Age

3 Years - 5 Years

Healthy Volunteers

Not accepted

Interventions

• Guanfacine (GUA) — DRUG
  After engaging in behavioral therapy, participants randomized into this group participants will be prescribed Guanfacine. Each child's prescribing clinician determines the form and dose of guanfacine that the child receives. Guanfacine (GUA) medication brand names include: Intuniv, Tenex, guanfacine hydrochloride- extended release, guanfacine hydrochloride- immediate release
• Methylphenidate (MPH) — DRUG
  Participants randomized into this group will be prescribed Methylphenidate. Each child's prescribing clinician determines the form and dose of methylphenidate that the child receives. Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Relexxii, Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid), methylphenidate hydrochloride- extended release, methylphenidate hydrochloride- immediate release

Study Details

This project will evaluate the effectiveness of Methylphenidate versus Guanfacine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 3 through 5 years (inclusive), as measured by clinician rating of global improvement.

Key Dates

Start date

Feb 28, 2026

Status verified

Jan 2026

Primary completion

Feb 28, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

370 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Guanfacine
  After engaging in behavioral therapy, participants randomized to this group will be prescribed Guanfacine. The child's prescribing clinician will determine the form and dose of Guanfacine that the child receives.
• Active Comparator: Methylphenidate
  After engaging in behavioral therapy, participants randomized to this group will be prescribed Methylphenidate. The child's prescribing clinician will determine the form and dose of Methylphenidate that the child receives.

Primary Outcome Measure

Clinical Global Impression-Improvement [ Time Frame: From enrollment to the end of the 16-week medication treatment. ]

Central Contacts

• Hannah Bush, MA
  513-636-1391
  [email protected]
• Jess Meline, MPH
  267-581-6578
  [email protected]

Locations (5)

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