Treating Young Children With Attention Deficit Hyperactivity Disorder

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-5
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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)

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.

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

Trial design

Treatments tested in this trial

  • Guanfacine (GUA)
  • Methylphenidate (MPH)

Treatment groups

370 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Children's Hospital of Philadelphia

Collaborator

Developmental Behavioral Pediatrics Research Network

Collaborator

Boston Children's Hospital, Boston, MA, USA

Collaborator

Children's Mercy Hospital Kansas City

Collaborator

Stanford University

Collaborator