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Protocol Details

A Cognitive Test Battery for Intellectual Disabilities

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Non-English Speaking


Intellectual Disabilities;
Cognitive Test Battery;
Outcome Measure;
Natural History

Recruitment Keyword(s)



intellectual disabilities;
Fragile X;
Down Syndrome

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Mental Health


People with intellectual disability (ID) may be limited in how they can think and behave. These limits affect their social and practical skills. Recent studies with animals have led to trials with drugs that may help to change both brain function and behavior in people with ID. But researchers need a reliable way to test how people in these trials respond to treatment.


This natural history study will explore how effectively 1 test can track intellectual changes among people with ID. This test is called the NIH-TCB (National Institutes of Health Toolbox Cognitive Battery).


People aged 4 years or older with ID. People older than 25 years must have a mental age >3 years.


All participants will have at least 1 visit to the clinic. This visit will last 6 to 7 hours.

Participants will take several tests to measure their thinking skills. The NIH-TCB test uses an iPad to measure skills like memory, attention, and reading.

The participant s parent or caregiver will complete a questionnaire. They will answer questions about the participant s background and development. Other topics will include how the participant communicates and relates to other people. The parent will talk about their relationship with their child for 5 minutes; this interview will be audio recorded.

Some participants may have a second visit 4 weeks later. This visit will last less than 2 hours. They will repeat the iPad-based test from their first visit.

Participants younger than 25 years may return for another visit 2 years later. They will take all of the same tests again. Their parent or caregiver will also repeat the questionnaire.

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Individuals will be pre-screened for eligibility with a parent, caregiver, or legally authorized representative. Pre-screening will occur either via telephone communication or in person when family members visit the MIND Institute and express interest in research study participation. Additional eligibility screening will be performed during the initial study visit.


1. Developmental Arm: Males or females who are (or were if enrolled in phase 1) between the ages of 4 and 25 years at enrollment with a diagnosis of intellectual disability associated with fragile X syndrome, Down syndrome, Williams syndrome, or from other or undetermined causes.

2. Aging Arm: Males or females who are > 25 years at enrollment with Down syndrome (including those with dementia) or fragile X syndrome with a mental age > 3.0 years as measured by the Stanford Binet-5th edition.

3. A full scale IQ below 80 as measured by the Stanford Binet-5th edition.

4. English Speaking.


1. Mental age under 1 year, 0 months as determined by the Stanford Binet-5th edition.

2. Uncorrectable vision impairment.

3. Significant motor impairment preventing touch screen or keypad responses.

4. History of head injury, brain infection, stroke or other neurological problems such as uncontrolled daily seizures or excessive sedation from medication.

5. Any changes to medication 6 weeks prior to study enrollment.

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Thompson T, Coleman JM, Riley K, Snider LA, Howard LJ, Sansone SM, Hessl D. Standardized Assessment Accommodations for Individuals with Intellectual Disability. Contemp Sch Psychol. 2018 Dec;22(4):443-457. doi: 10.1007/s40688-018-0171-4. Epub 2018 Jan 23. PMID: 30420939; PMCID: PMC6226246.

Shields RH, Kaat AJ, McKenzie FJ, Drayton A, Sansone SM, Coleman J, Michalak C, Riley K, Berry-Kravis E, Gershon RC, Widaman KF, Hessl D. Validation of the NIH Toolbox Cognitive Battery in intellectual disability. Neurology. 2020 Mar 24;94(12):e1229-e1240. doi: 10.1212/WNL.0000000000009131. Epub 2020 Feb 24. PMID: 32094241; PMCID: PMC7274932.

Hessl D, Sansone SM, Berry-Kravis E, Riley K, Widaman KF, Abbeduto L, Schneider A, Coleman J, Oaklander D, Rhodes KC, Gershon RC. The NIH Toolbox Cognitive Battery for intellectual disabilities: three preliminary studies and future directions. J Neurodev Disord. 2016 Sep 6;8(1):35. doi: 10.1186/s11689-016-9167-4. PMID: 27602170; PMCID: PMC5012003.

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Principal Investigator

Referral Contact

For more information:

Audrey E. Thurm, Ph.D.
National Institute of Mental Health (NIMH)
(301) 496-6768

Margaret J. Pekar
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 10
Room 1C250
10 Center Drive
Bethesda, Maryland 20892
(301) 435-7962

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

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