Evaluating Cognitive Outcomes in Down Syndrome

NCT04208685 | Active Not Recruiting

• 1 other identifier: 2018-0253
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• Psychometric properties of measures in the assessment battery, specifically establishing their test-retest reliability, validity, and sensitivity to change

  Through study completion, an average of 4 years

Secondary Outcomes (2)

• Psychometric properties of the measures as a function of variations in participant age, gender, and degree of ID

  Through study completion, an average of 4 years

• Psychometric properties of the measures as a function of variations in the participants' physical health and medical comorbidities

  Through study completion, an average of 4 years

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from clinics at Cincinnati Children's Hospital Medical Center (CCHMC), community physicians, and the Jane and Richard Thomas Center for Down Syndrome at CCHMC, as well as from the community physicians, clinics, and DS clinic at CSU. In addition, the Down Syndrome Association of Greater Cincinnati (DSAGC) and the Rocky Mountain Down Syndrome Association (RMDSA) will publicize our study through social media and their mailing lists that reaches over 12,000 families combined. Subjects may also be recruited from community programs such as baseball teams, Special Olympics, etc.

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Colorado State University: collaborator

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Anna Esbensen, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 23, 2019
• Study Start: June 18, 2018
• Primary Completion: June 30, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Given the nature of data collection across multiple sites, data will only be made available upon completion of sampling and primary analyses outlined in the proposal. Data will be shared at the completion of the project according to any and all NIH guidelines. Data also will be archived in accordance with the scientific journals in which reports from the project are published.

Locations

US (2)