Treating Young Children With Attention Deficit Hyperactivity Disorder
Key facts
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Where
- Boston, Cincinnati, Kansas City, Palo Alto, and Philadelphia, United StatesSee the 5 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 370 people, planned
- Started
- 16 Feb 2026
- Expected to end
- Jul 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Guanfacine (GUA)
- Methylphenidate (MPH)
- Record updated
- 14 September 2026
Who can take part
- Age
- 3 years to 5 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Males or females 3 to 5 years of age, inclusive (e.g. children age 5 years, 11 months are eligible)
- 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)
- 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)
- The child's clinician and caretakers have decided on or are considering initiating drug therapy (with either Methylphenidate or Guanfacine)
- Primary language is English or Spanish
Who cannot take part
- History of taking Methylphenidate or Guanfacine. Prior use of other Attention-Deficit/Hyperactivity Disorder medications or other psychotropic medications is allowed
- 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)
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 5 years old?
Where in United States
- Boston Children's HospitalBoston, United StatesContact: Ellie WadeTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Hannah R Bush, MATaking people
- Children's Mercy HospitalKansas City, United StatesContact: Luis Saniz Y Diaz, BBATaking people
- Stanford Medicine Children's HealthPalo Alto, United StatesContact: Melisa Deras, MSTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Jessica Meline, MPHTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- GuanfacineExisting treatment, for comparison
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.
Treatment: Guanfacine (GUA)
- MethylphenidateExisting treatment, for comparison
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.
Treatment: Methylphenidate (MPH)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparing Medication Treatments for Neurodevelopmental Differences in Young Children on Rates of Beneficial Response
- Fit questions
- Built from NCT07300956, who can take part
- Record updated
- 14 September 2026