Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease (NCT07226219) | Clinical Trial Compass
RecruitingPhase 1
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
United States72 participantsStarted 2025-11-25
Plain-language summary
The purpose of this study is to determine if patients with sickle cell disease (SCD) can consistently take a drug called Methylphenidate (MPH) daily, once a day for 4 weeks to help with any thinking, attention or schoolwork problems and if they have any side effects.
The study will assess any thinking or attention problems participants may have both before taking this drug and after. Additionally, the study will assess the decision-making process of the caregiver that may influence using this drug or not.
Primary Objective:
• Assess the feasibility, acceptability, and adherence to MPH treatment in children with SCD and EF deficits.
Secondary Objective:
• Evaluate neurobehavioral and safety outcomes following MPH treatment.
Exploratory Objective:
• Evaluate decision-making and determinants influencing methylphenidate utilization among parents.
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with SCD of any genotype
* Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
* Between the ages of 8.0 and 17.9 years
\*Included if performance measure, rating scale or diagnostic criteria met (within the past 2 years):
* \*Score at or below the 16th percentile on any 2 out of 4 performance measures:
* NIH Toolbox Flanker
* NIH Toolbox List Sorting
* NIH Toolbox Dimensional Change Card Sort Test (DCST)
* Wechsler Intelligence Scale for Children (WISC) -5/ Wechsler Adult Intelligence Scale (WAIS)-4 Digit Span Forward (DSF)
* \*Score at or above the 84th percentile on any 1 out of 2 parent rating scales:
* BRIEF-2 Global Executive
* BASC-3 Attention
* \*Have a documented diagnosis of attention deficit / hyperactivity disorder (any subtype)
* English as the primary language
* Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
* Negative pregnancy test
Exclusion Criteria:
* Primary language other than English
* Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test
* Uncontrolled seizures (seizure within the past 6 months)
* Cardiomyopathy or known congenital structural cardiac defects
* Stenotic valvular disease, left coronary artery stenosis, or history of myocarditis or pericarditis
* History of heart arrhythmia including ventricular tachy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess feasibility of methylphenidate
Timeframe: Feasibility is measured during the initial recruitment process for each participant.
2
Assess acceptability of methylphenidate
Timeframe: Acceptability ratings are captured at baseline and after 4 weeks of treatment with methylphenidate.
3
Assess adherence to methylphenidate
Timeframe: Adherence is measured on a weekly basis through 4 weeks of treatment