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Treating Young Children With Attention Deficit Hyperactivity Disorder

NCT ID: NCT07300956
Registry status: Recruiting
Study type: Interventional
Phase: Phase 4
Sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 370 participants (Estimated).

What is being studied

Intervention: Acids, Carbocyclic
Intervention: Amidines
Intervention: Carboxylic Acids
Intervention: Guanfacine
Drug: Guanfacine (GUA)
Intervention: Guanidines
Intervention: Heterocyclic Compounds
Intervention: Heterocyclic Compounds, 1-Ring
Intervention: Methylphenidate
Drug: Methylphenidate (MPH)
Intervention: Organic Chemicals
Intervention: Phenylacetates
Intervention: Piperidines

Who may be eligible

Ages: 3 Years to 5 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

5 study locations are listed.

Recruiting site status is explicitly provided for 5 locations; 5 are listed as Recruiting.

Countries: United States

California, United States: 1
Massachusetts, United States: 1
Missouri, United States: 1
Ohio, United States: 1
Pennsylvania, United States: 1

Sample of listed locations

Stanford Medicine Children's Health — Palo Alto, California, 94304, United States — Recruiting
Boston Children's Hospital — Boston, Massachusetts, 02115, United States — Recruiting
Children's Mercy Hospital — Kansas City, Missouri, 64108, United States — Recruiting
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, 45229, United States — Recruiting
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, 19104, United States — Recruiting

Study details

Start date: February 16, 2026
Primary completion date: February 1, 2030
Completion date: July 1, 2030
First posted: December 24, 2025
Collaborators: Boston Children's Hospital, Boston, MA, USA, Children's Hospital of Philadelphia, Children's Mercy Hospital Kansas City, Developmental Behavioral Pediatrics Research Network, Patient-Centered Outcomes Research Institute, Stanford University

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07300956
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07300956 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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