Pilot Trial of Stimulant Treatment to Address Attention and Executive Deficits Among Children With Sickle Cell Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• 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 or rating scale criteria met:

• \*Score 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 above the 84th percentile on any 1 out of 2 parent rating scales:

‣ BRIEF-2 Global Executive

⁃ BASC-3 Attention

• English as the primary language

• Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines

• Negative pregnancy test

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Andrew Heitzer, PhD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2028-08
Participants
Target number of participants: 72
Treatments
Experimental: Methylphenidate Treatment Group
All participants in this single-arm pilot study will receive extended-release methylphenidate for 4 weeks. The intervention is designed to evaluate feasibility, acceptability, adherence, and safety of stimulant treatment in children and adolescents with sickle cell disease (SCD) and executive functioning deficits.
Sponsors
Leads: St. Jude Children's Research Hospital

This content was sourced from clinicaltrials.gov