Evaluating Cognitive Outcomes in Down Syndrome
Status unconfirmed
Conditions studied: Down Syndrome
In brief
As basic and behavioral science identify new ways to improve cognition and behavior in individuals with Down syndrome (DS), the lack of rigorous outcome measures represents an important problem for interpreting findings. Null findings in clinical trials could result from insensitive outcome measures, rather than ineffectiveness of treatment. The long-term goal is to improve measurement of outcomes for children and adults with DS. Towards that goal, the investigators propose to test and refine a battery of cognitive measures that can be used in treatment studies focused on school-aged children and adults with Down syndrome. The batteries are designed to assess key domains of the DS phenotype where gaps remain in outcome measures, including attention, executive function, learning and memory, processing speed, and social cognition. The investigators will examine the psychometric properties of measures (test-retest, validity, sensitivity to change), and to evaluate differences in the psychometric properties of measures as a function of variations in participant age, gender, degree of ID, and the participants' physical health and medical comorbidities. The investigators will evaluate at least 80 children and 50 adults with Down syndrome, per site, at five time points to evaluate key domains with a diverse and novel range of methods. This proposal aims to provide a preliminary evaluation to support the enhancement of clinical outcome measures, which ultimately will increase the accuracy in documenting improvements in the lives of children and young adults with Down syndrome.
Key facts
- Study ID
- NCT04208685
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 202
- Starts
- 2018-06-18
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2023-12-26
Who can join
Age: 6 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 6-35 years old at the time of consent.
- Documented diagnosis of DS.
- Nonverbal mental age of at least 36 months to complete assessment battery (per parent/caregiver/young adult self-report).
- Willingness to maintain stables dosages of current medication or ongoing treatment for the duration of the study to limit changes while evaluating outcome measures.
- Parent/caregiver/self-report that participant will be able to complete the study, including all visits.
You may not qualify if…
- History of blindness, deafness, or serious motor impairment
Where it is running
- Colorado State University — Fort Collins, Colorado, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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