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Treating Young Children With Attention Deficit Hyperactivity Disorder

RecruitingPhase 4

Comparing Medication Treatments for Neurodevelopmental Differences in Young Children on Rates of Beneficial Response

Who can join

Ages 3 to 5 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Males or females 3 to 5 years of age, inclusive (e.g. children age 5 years, 11 months are eligible).
2. Child has a confirmed diagnosis of moderate or severe Attention-Deficit/Hyperactivity Disorder (diagnostic code: F90.9) based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria, review of supportive evidence (caregiver interview, behavioral observations, Vanderbilt Attention-Deficit/Hyperactivity Disorder Rating Scale results, any school or daycare information provided by caregiver).
3. Clinician-rated Clinical Global Impairment-Severity (see description below) rating of ≥4 (denoting moderate or greater impairment due to their Attention-Deficit/Hyperactivity Disorder symptoms).
4. The child's clinician and caretakers have decided on or are considering initiating drug therapy (with either Methylphenidate or Guanfacine).
5. Primary language is English or Spanish.

Exclusion Criteria:

1. History of taking Methylphenidate or Guanfacine. Prior use of other Attention-Deficit/Hyperactivity Disorder medications or other psychotropic medications is allowed.
2. Current use of other Attention-Deficit/Hyperactivity Disorder medications (e.g., amphetamines), other psychotropic medications (e.g., atypical antipsychotics or serotonin reuptake inhibitors), or centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines)
3. Electronic Health Record documentation of moderate to severe global developmental delay (F88) or intellectual disability (F70), or a score of \<55 on the Vineland Adaptive Behavior Scales-3.
4. Medical contraindications to taking Methylphenidate or Guanfacine, including cardiac risk factors (e.g. known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease), increased intraocular pressure, glaucoma, verbal tics, Tourette's Syndrome, psychosis

About the study

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.

What is being tested

Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 370 · Started: Feb 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07300956

Locations in the U.S.

CaliforniaStanford Medicine Children's Health, Palo Alto
MassachusettsBoston Children's Hospital, Boston
MissouriChildren's Mercy Hospital, Kansas City
OhioCincinnati Children's Hospital Medical Center, Cincinnati
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.