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NCT05301361

Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities

Enrolling by Invitation
PHASE1Ages 6–24Interventional
University of California, Davis
~68 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:Methylphenidate Oral Solution

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite score of NIHTB-CB Flanker, Dimensional Change Card Sort, List Sorting and Speeded Matching tests.
Measured over 11 weeks

Conditions

Intellectual Disability
Fragile X Syndrome
Down Syndrome
Attention Deficit Hyperactivity Disorder

Explore related trials

Attention Deficit Hyperactivity DisorderDown SyndromeFragile X SyndromeIntellectual Disability

Where it's being run

3 sites across 3 states
California1
Illinois1
Ohio1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

IQ below 80
Mental age 3.0 or higher (Stanford Binet)
Diagnosis of Intellectual Disability
Diagnosis of ADHD
Ability to complete valid NIHTB-CB tests at screening/baseline

Exclusion

stimulant use within 2 weeks prior to randomization
history of a sensitivity reaction to stimulants
presence of significant comorbid psychiatric or medical disorder/illness deemed by the site physician as inappropriate for stimulant use (uncontrolled epilepsy, bipolar disorder, psychosis, severe OCD, hypertension, tachycardia hypertension, failure to thrive, psychosis for example)
a household resident with a current substance abuse disorder

What this trial measures

  • Composite score of NIHTB-CB Flanker, Dimensional Change Card Sort, List Sorting and Speeded Matching tests.11 weeks

    The composite score is calculated as the average of the non-age adjusted standard scores of each of these four tests. These standard scores have a mean of 100 and SD of 15. A minimum of 3/4 valid scores is required to calculate an average composite score.