Treating Young Children With Attention Deficit Hyperactivity Disorder

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-5
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: GuanfacineActive comparator 1 intervention
Group B: MethylphenidateActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Medication discontinuation within 16 weeks

The percent of participants who discontinue medication prior to 16 weeks will be measured to assess treatment acceptability.

Time frame
From medication randomization assignment to the end of the 16-week medication treatment.
2

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.

Time frame
From enrollment to the end of the 16-week medication treatment.
3

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.

Time frame
From enrollment to the end of the 16-week medication treatment.
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

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