Attention-Deficit/Hyperactivity Disorder (ADHD)Phase 4TYCANCT07300956
Treating Young Children With Attention Deficit Hyperactivity Disorder
A Phase 4 study testing Guanfacine (GUA) and Methylphenidate (MPH) in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- Guanfacine (GUA) and Methylphenidate (MPH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Feb 2026to Jul 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Ellie Wade, ellie.wade@childrens.harvard.edu
Elizabeth Harstad, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Hannah R Bush, MA, Hannah.Bush@cchmc.org
Tanya E Froehlich, MD
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Luis Saniz Y Diaz, BBA, lesainzydiaz@cmh.edu
Simone Moody, PhD
- Recruiting
Stanford Medicine Children's Health
Palo Alto, California, 94304
Melisa Deras, MS, mderas08@stanford.edu
Irene Loe, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Jessica Meline, MPH, melinej@chop.edu
Nathan Blum, MD
About this study
Official title: Comparing Medication Treatments for Neurodevelopmental Differences in Young Children on Rates of Beneficial Response
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.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders, affecting 2-3% of U.S. children under 6 (also called preschool-age children. Preschool Attention-Deficit/Hyperactivity Disorder is linked to difficulties in school or daycare, with friendships and family relationships, and accidental injuries. Behavioral therapy is recommended as the first step in treating preschool-age Attention-Deficit/Hyperactivity Disorder. However, for some children, behavior therapy is not enough. For these children, medication may also be needed to treat their Attention-Deficit/Hyperactivity Disorder.
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.
- Being tested
- Guanfacine (GUA), Methylphenidate (MPH)
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Methylphenidate, Guanfacine, Preschool Children, Comparative Effectiveness, Prospective Study
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. 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. Receives: Drug: Methylphenidate (MPH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the 16-week medication treatment.
Secondary outcomes (7)
Medication discontinuation within 16 weeks
The percent of participants who discontinue medication prior to 16 weeks will be measured to assess treatment acceptability.
Measured: From medication randomization assignment to the end of the 16-week medication treatment.
Vanderbilt Attention-Deficit/Hyperactivity Disorder Parent Rating Scales
This caregiver-completed questionnaire includes 55 items across three sections. The first section contains 18 Attention-Deficit/Hyperactivity Disorder symptom items rated on a three-point scale from "Never" (0) to "Very Often" (3), with Attention-Deficit/Hyperactivity Disorder total symptom scores ranging from a minimum of 0 to a maximum of 54. The second section contains 29 items related to behavioral and mental health comorbidity symptoms (e.g., oppositional defiant, disordered conduct, anxiety, and mood symptoms) rated on a three-point scale from "Never" (0) to "Very Often" (3), with comorbidity total symptom scores ranging from a minimum of 0 to a maximum of 87. The third section includes eight performance/impairment-related items rated on a five-point scale from "Excellent" (1) to "Problematic" (5), with performance/impairment total scores ranging from 8 to 40. On all sections, higher scores indicate more severe symptoms and/or greater impairment.
Measured: From enrollment to the end of the 16-week medication treatment.
Vanderbilt Attention-Deficit/Hyperactivity Disorder Teacher Rating Scales
This measure, completed by teachers (if applicable), includes 43 items divided into three sections. The first section contains 18 Attention-Deficit/Hyperactivity Disorder symptoms items rated on a three-point scale from "Never" (0) to "Very Often" (3), with Attention-Deficit/Hyperactivity Disorder total symptom scores ranging from a minimum of 0 to a maximum of 54. The second section contains 17 items related to behavioral and mental health comorbidity symptoms (e.g., oppositional defiant, disordered conduct, anxiety, and mood symptoms) rated on a three-point scale from "Never" (0) to "Very Often" (3), with comorbidity total symptom scores ranging from 0 51. The third section includes eight performance/impairment-related items rated on a five-point scale from "Excellent" (1) to "Problematic" (5), with performance/impairment total scores ranging from 8 to 40. On all sections, higher scores indicate more severe symptoms and/or greater impairment.
Measured: From enrollment to the end of the 16-week medication treatment.
Parenting Stress Index Short Form
Caregivers will complete the Parenting Stress Index Short Form, which consists of 36 items. Each item is rated on a five-point scale ranging from 1= "Strongly Disagree" to 5= "Strongly Agree." Total scores can range from 36 to 180, with higher scores indicating greater levels of parenting stress.
Measured: From enrollment to the end of the 16-week medication treatment.
Affective Reactivity Index - Caregiver
This measure, completed by caregivers, includes 7 items. For each item, the caregiver responds by answering 0="Not True," 1="Somewhat True," or 2="Certainly True." Total scores range from 0 to 14. Higher scores indicate higher levels of irritability, whereas lower scores indicate lower levels of irritability.
Measured: From enrollment to the end of the 16-week medication treatment.
Affective Reactivity Index - Teacher
This measure, completed by teachers (if applicable), includes 7 items. For each item, teachers respond by answering 0="Not True," 1="Somewhat True," or 2="Certainly True." Total scores range from 0 to 14. Higher scores indicate higher levels of irritability, whereas lower scores indicate lower levels of irritability.
Measured: From enrollment to the end of the 16-week medication treatment.
Pittsburgh Side Effects Rating Scale
The Pittsburgh Side Effects Rating Scale will be completed by caregivers and will measure safety and tolerability. This version of the scale has been adapted to include one additional item related to daytime sleepiness, a known side effect of Guanfacine, resulting in a total of 14 items. Each item is rated on a scale from 0 to 3, where 0 means the side effect is not present, 1 means the side effect is mild, 2 means the side effect is moderate, and 3 means the side effect is severe. Total scores range from 0 to 42, with 0 indicating no side effect symptoms and higher scores indicating more/worse side effects.
Measured: From enrollment to the end of the 16-week medication treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start16 Feb 2026
- Primary completionFeb 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Children's Hospital of Philadelphia, Developmental Behavioral Pediatrics Research Network, Boston Children's Hospital, Boston, MA, USA, Children's Mercy Hospital Kansas City, Stanford University
- Responsible party
- Principal investigator, Tanya Froehlich, MD, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300956
- Sponsor's protocol ID
- BPS-2024C2-39495
- Acronym
- TYCA
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, we do not plan to share individual participant data from this study. Our Institutional Review Board approval is contingent upon maintaining participant privacy and confidentiality, and sharing individual-level data would not be consistent with these requirements. While we may share aggregated, de-identified summary findings in publications or presentations, we cannot share any data that could potentially be linked back to individual participants. Only summary-level results will be made publicly available through publications and ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Medication Treatments for Neurodevelopmental Differences in Young Children on Rates of Beneficial Response
- ClinicalTrials.gov ID
- NCT07300956
- Acronym / sponsor ID
- TYCA / BPS-2024C2-39495
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Methylphenidate, Guanfacine, Preschool Children, Comparative Effectiveness, Prospective Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Children's Hospital of Philadelphia, Developmental Behavioral Pediatrics Research Network, Boston Children's Hospital, Boston, MA, USA, Children's Mercy Hospital Kansas City, Stanford University
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders, affecting 2-3% of U.S. children under 6 (also called preschool-age children. Preschool Attention-Deficit/Hyperactivity Disorder is linked to difficulties in school or daycare, with friendships and family relationships, and accidental injuries. Behavioral therapy is recommended as the first step in treating preschool-age Attention-Deficit/Hyperactivity Disorder. However, for some children, behavior therapy is not enough. For these children, medication may also be needed to treat their Attention-Deficit/Hyperactivity Disorder.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guanfacine | Active comparator | Drug: Guanfacine (GUA)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. |
| Methylphenidate | Active comparator | Drug: Methylphenidate (MPH)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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Guanfacine |
| 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 | Drug | Methylphenidate |
Primary outcome
Clinical Global Impression-Improvement
Time frame: From enrollment to the end of the 16-week medication treatment.
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.
7 secondary outcomes
Medication discontinuation within 16 weeks
Time frame: From medication randomization assignment to the end of the 16-week medication treatment.
Vanderbilt Attention-Deficit/Hyperactivity Disorder Parent Rating Scales
Time frame: From enrollment to the end of the 16-week medication treatment.
Vanderbilt Attention-Deficit/Hyperactivity Disorder Teacher Rating Scales
Time frame: From enrollment to the end of the 16-week medication treatment.
Parenting Stress Index Short Form
Time frame: From enrollment to the end of the 16-week medication treatment.
Affective Reactivity Index - Caregiver
Time frame: From enrollment to the end of the 16-week medication treatment.
Affective Reactivity Index - Teacher
Time frame: From enrollment to the end of the 16-week medication treatment.
Pittsburgh Side Effects Rating Scale
Time frame: From enrollment to the end of the 16-week medication treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. At this time, we do not plan to share individual participant data from this study. Our Institutional Review Board approval is contingent upon maintaining participant privacy and confidentiality, and sharing individual-level data would not be consistent with these requirements. While we may share aggregated, de-identified summary findings in publications or presentations, we cannot share any data that could potentially be linked back to individual participants. Only summary-level results will be made publicly available through publications and ClinicalTrials.gov.
Related trials for Attention-Deficit/Hyperactivity Disorder (ADHD)
Not yet recruiting
Development and Evaluation of a Digital Game Intervention Targeting Children Vulnerable to ADHD
ADHD or ADHD Traits
RecruitingObservational study
Multimodal Biomarkers Predicting Medication-Induced Adverse Effects in Children With ADHD
ADHD
Recruiting
Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits
ADHD
Not yet recruitingObservational study
Phase 1: Thrive Together
Attention-Deficit/Hyperactivity Disorder (ADHD)
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guanfacine (GUA) and Methylphenidate (MPH) in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Bush, MA (513-517-8839, ddbp.adhd.research@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression-Improvement (time frame: From enrollment to the end of the 16-week medication treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.