Treating Young Children With Attention Deficit Hyperactivity Disorder

NCT07300956 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: BPS-2024C2-39495
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

Attention-Deficit/Hyperactivity Disorder; Methylphenidate; Guanfacine; Preschool Children; Comparative Effectiveness; Prospective Study

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Improvement

  The Clinical Global Impression-Improvement scale is a seven-point rating tool that evaluates how a participant's Attention-Deficit/Hyperactivity Disorder symptoms have changed since their baseline measurement. Although this scale can be used for other mental health conditions, in this study it is applied specifically to Attention-Deficit/Hyperactivity Disorder. A score of "1" indicates "very much improved," while a score of "7" indicates "very much worse." Higher scores reflect a worse outcome.

  From enrollment to the end of the 16-week medication treatment.

Secondary Outcomes (7)

• Medication discontinuation within 16 weeks

  From medication randomization assignment to the end of the 16-week medication treatment.

• Vanderbilt Attention-Deficit/Hyperactivity Disorder Parent Rating Scales

  From enrollment to the end of the 16-week medication treatment.

• Vanderbilt Attention-Deficit/Hyperactivity Disorder Teacher Rating Scales

  From enrollment to the end of the 16-week medication treatment.

• Parenting Stress Index Short Form

  From enrollment to the end of the 16-week medication treatment.

• Affective Reactivity Index - Caregiver

  From enrollment to the end of the 16-week medication treatment.

Study Arms (2)

Guanfacine

ACTIVE COMPARATOR

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.

Drug: Guanfacine (GUA)

Methylphenidate

ACTIVE COMPARATOR

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.

Drug: Methylphenidate (MPH)

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

Guanfacine

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

Methylphenidate

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• 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

Study Sites (5)

Stanford Medicine Children's Health

Palo Alto, California, 94304, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hannah Bush, MA

CONTACT

513-636-1391; Hannah.Bush@cchmc.org

Jess Meline, MPH

CONTACT

267-581-6578; melinej@chop.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director, Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)