NCT07300956 Treating Young Children With Attention Deficit Hyperactivity Disorder
| NCT ID | NCT07300956 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Attention-Deficit/Hyperactivity Disorder (ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 370 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 370 participants in total. It began in 2026-02-16 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07300956 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 5 Years, studying Attention-Deficit/Hyperactivity Disorder (ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07300956 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07300956 currently recruiting?
Yes, NCT07300956 is actively recruiting participants. Contact the research team at ddbp.adhd.research@cchmc.org for enrollment information.
Where is the NCT07300956 trial being conducted?
This trial is being conducted at Palo Alto, United States, Boston, United States, Kansas City, United States, Cincinnati, United States and 1 additional location.
Who is sponsoring the NCT07300956 clinical trial?
NCT07300956 is sponsored by Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 370 participants.