Treating Young Children With Attention Deficit Hyperactivity Disorder
NCT ID: NCT07300956
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
370 participants
INTERVENTIONAL
2026-02-28
2030-07-31
Brief Summary
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Detailed Description
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The most common medications used to treat Attention-Deficit/Hyperactivity Disorder in preschool-age children are Methylphenidate and Guanfacine. Currently, there is not enough research to help families and doctors choose between these two medications when treating this age group. This research study will fill this gap by directly comparing the benefits and side effects of Methylphenidate and Guanfacine for treating Attention-Deficit/Hyperactivity Disorder in this age group, giving families and clinicians the information they need to make evidence-based treatment choices.
The main goal of this study is to compare the effectiveness of Methylphenidate and Guanfacine in children ages 3-5, focusing on clinically meaningful improvement in overall functioning. Clinicians will measure the child's improvement using the Clinical Global Impressions scale.
There are also secondary goals in this study. One of those secondary goals is to understand how acceptable and tolerable each of these medications is, from the family perspective and the clinician perspective. This will be learned in a few ways. It will be measured through how long participants choose to stay on the medication and through surveys from caregivers about medication side effects (Pittsburgh Side Effect Rating Scale) at the beginning of the study and again 4, 8, 12, and 16 weeks after starting medication.
The other secondary goals are to understand if medication choice impacts a child and their family in other ways (e.g. behavioral symptoms, parenting stress) and learn about any factors that may influence a child's response to medication (e.g. age, initial symptoms). This information will primarily come from caregiver surveys (Parenting Stress Index, Vanderbilt Attention-Deficit/Hyperactivity Disorder Parent Rating Scales, Affective Reactivity Index). If the caregiver agrees, and the child has a teacher, their teacher will also complete surveys (Vanderbilt Attention-Deficit/Hyperactivity Disorder Teacher Rating Scales, Affective Reactivity Index). The Vanderbilt Attention-Deficit/Hyperactivity Disorder Rating Scales are completed at the beginning of the study and again 4, 8, 12, and 16 weeks after starting medication. The Parenting Stress Index and Affective Reactivity Index are completed at the beginning of the study and again 8 and 16 weeks after starting medication.
Caregivers and their child will be required to attend 3 in person visits (before starting medication and again 8 weeks and 16 weeks after starting medication. At these visits, a study doctor will measure the child's height, weight, blood pressure, and heart rate to make sure that the medication is safe to start or continue. The other 3 visits with study doctors can be in-person or online. If a teacher is completing study surveys, they will all be available through a secure, online platform.
This study uses a randomization to compare the effectiveness of Methylphenidate and Guanfacine in preschool-age children with Attention-Deficit/Hyperactivity Disorder, including how side effects may differ.
This study aims to provide evidence-based guidance on using Methylphenidate and Guanfacine in treating Attention-Deficit/Hyperactivity Disorder in preschool-age children. Evidence about each medicine's effectiveness in this age group will help families and clinicians make more informed decisions when treating preschool-age children with Attention-Deficit/Hyperactivity Disorder.
This research study is being co-designed with parents, clinicians, and health systems stakeholders. Working with these stakeholders helps ensure that the research will be practical for families, clinicians, and health systems. Caregivers of children with Attention-Deficit/Hyperactivity Disorder, who are 3-5 (inclusive) will be recruited to participate. Across the United States, 5 total sites will participate to enroll a total of 370 children in this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Guanfacine
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.
Guanfacine (GUA)
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
Methylphenidate
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.
Methylphenidate (MPH)
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
Interventions
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Guanfacine (GUA)
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
Methylphenidate (MPH)
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
Eligibility Criteria
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Inclusion Criteria
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
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
3 Years
5 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Developmental Behavioral Pediatrics Research Network
UNKNOWN
Boston Children's Hospital, Boston, MA, USA
OTHER
Children's Mercy Hospital Kansas City
OTHER
Stanford University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Tanya Froehlich, MD
Division Director, Professor
Locations
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Stanford Medicine Children's Health
Palo Alto, California, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Melisa Deras, MS
Role: primary
Meaghan Bowen, BS
Role: primary
Luis Saniz Y Diaz, BBA
Role: primary
Hannah R Bush, MA
Role: primary
Jessica Meline, MPH
Role: primary
Other Identifiers
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BPS-2024C2-39495
Identifier Type: -
Identifier Source: org_study_id