Actively Recruiting
The INCLUDE Project's Collaboration for Down Syndrome Progress (CDP) Program to Understand Co-occurring Conditions Across the Lifespan
Led by RTI International · Updated on 2026-06-04
1400
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
Sponsors
R
RTI International
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting the Collaboration for Down Syndrome Progress (CDP), a long-term observational study that follows people with Down syndrome across all ages. The study aims to better understand the health, development, and everyday experiences of individuals with Down syndrome over time. It collects consistent data across multiple sites to learn why certain health conditions are more common in this population and how to improve their care and quality of life. Participants complete standardized assessments including medical history, neurobehavioral evaluations, physical exams, and review of health records. Biological samples such as blood, saliva, and tongue swabs are collected to study genetics and other biological markers. Optional activities include sleep studies, activity monitoring with wearable devices, brain imaging using MRI, and metabolic and endocrine tests. These data and samples are stored and shared with researchers to support future studies. Participants and their caregivers provide information through questionnaires and clinical assessments at multiple visits. The study monitors enrollment over four years and collects data to track health and developmental changes. Optional subsample studies allow for deeper evaluation in areas like sleep, movement, brain structure, and metabolism. The study ensures data privacy and aims to advance understanding of co-occurring health issues in Down syndrome to guide better clinical care and research.
CONDITIONS
Brief Title
Collaboration for Down Syndrome Progress (CDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individual diagnosed with Down syndrome, including Trisomy 21, mosaic, or translocations
- Primary language is English, Spanish, or Portuguese
- Able to attend in-person or remote study visits
- Able to provide accurate clinical and family history information
- Biological parents willing to provide biological samples
- Healthy control infants for imaging subsample must be born after 36 weeks gestation and have at least one older sibling
You will not qualify if you...
- Involvement poses risk of mental or physical harm as determined by a healthcare professional
- Known genetic syndromes affecting neurobehavioral development other than Down syndrome (e.g., Fragile X, Williams, Prader-Willi)
- Birth weight under 2000 grams or gestational age under 34 weeks for Down syndrome infants, under 37 weeks for controls
- Significant perinatal adversity, in utero neurotoxin exposure, or gestational diabetes requiring medication
- Major medical conditions unrelated to Down syndrome affecting growth, cognition, or sensory function (e.g., stroke, congenital infections, meningitis)
- Severe medical issues in Down syndrome infants affecting development beyond Down syndrome (e.g., cyanotic heart defects, frailty from surgeries or hospital stays)
- Contraindication for MRI
- English not predominant home language
- Family history of psychosis or bipolar disorder (controls only)
- Family history of autism spectrum disorder in controls for imaging subsample
- Participants under 12 treated with positive airway pressure for obstructive sleep apnea
- For WatchPAT device: weight under 65 pounds, presence of pacemaker or sustained cardiac arrhythmias in sleep subsample participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Up to 4 years
Participants undergo standardized assessments that include medical history, neurobehavioral evaluations, physical examinations, and review of electronic health records. Biospecimens such as blood, saliva, and tongue swabs are collected to support various analyses. Data are harmonized across multiple sites and contributed to a centralized data repository for ongoing research.
Periodic visits for assessments and biospecimen collection as scheduled across sites
Duration - Variable depending on subsample participation
Participants may opt to take part in additional studies involving home sleep apnea testing, wearable activity monitoring, neuroimaging using MRI, and metabolic and endocrine laboratory profiling, providing deeper phenotyping relevant to co-occurring conditions in Down syndrome.
Additional visits depending on subsample study participation
Trial Site Locations
Total: 16 locations
1
University of California Irvine
Orange, California, United States, 92868
Not Yet Recruiting
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
4
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
5
John Hopkins University
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
6
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
7
Washington University in St. Louis
St Louis, Missouri, United States, 63108
Not Yet Recruiting
8
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
9
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
10
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
11
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15203
Not Yet Recruiting
12
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Not Yet Recruiting
13
Texas Children's Hosptial/Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
14
University of Texas Health Science Center at San Antionio
San Antonio, Texas, United States, 78207
Not Yet Recruiting
15
University of Washington
Seattle, Washington, United States, 98195
Not Yet Recruiting
16
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
J
Jessica E Hunter, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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