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Cognitive Outcome Measures in School Age Children with Down Syndrome (ECODS)

Award Number: R01HD093754
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/20/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2029

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Cognitive Outcome Measures in School Age Children with Down Syndrome (ECODS) - PROJECT SUMMARY There is a fundamental gap in the availability of cognitive outcome measures that are reliable and sensitive to detecting change among children with Down syndrome (DS). Lack of such outcome measures represents an important problem to interpreting clinical trials aimed at improving the lives of individuals with DS. Without evidence-based cognitive outcome measures, future treatment trials in this population will remain suboptimal due to poor study measures. Despite some promising findings in currently recommended assessment batteries, the evidence base for cognitive outcome measures in DS is limited. Multi-site studies evaluating the reliability and validity of outcome measures are the needed next step towards supporting the evaluation of new pharmaceutical and clinical interventions for children with DS. Working groups convened by NICHD of leading experts in DS led to recommendations of promising measures for use in this population. The prior R01 HD093754 began evaluating the psychometric properties of recommended promising measures and expanded upon those recommendations by evaluating individual variability and accounting for the method of assessment (verbal, nonverbal, computer, parent-report) to support our understanding of performance within a cognitive domain. The proposed renewal continues evaluating the psychometric properties of measures that fill the gaps in cognitive domains (Study 1), extends the natural history of change in performance on measures with annual follow-up visits (Study 2), and refines the measurement of individual variability to include co-occurring medical and mental health conditions across both Studies. The overall objective of this application is to establish the psychometric properties of individual clinical outcome measures in children with DS across the cognitive domains of episodic memory, executive functioning (set-shifting, inhibitory control, working memory), learning and memory, and processing speed. Our rationale for working with this population is that DS is associated with a distinct pattern of cognitive strengths and weaknesses related to their neuroanatomy. Thus, the selection of outcome measures to be evaluated needs to take into account the DS behavioral phenotype. We propose three specific aims: 1) To examine the psychometric properties of selected cognitive outcome measures with children with DS. 2) To evaluate differences in the psychometric properties of the measures as a function of variations in demographics and co-occurring medical and mental health conditions. 3) To characterize the developmental trajectories of cognition and executive functioning. To achieve these aims, 200 children in Study 1 ages 6-17 years with DS will participate in repeated neuropsychological assessments with follow-up evaluations at 2 weeks, 6 months, and 1 year. We will continue to follow at minimum 120 children from R01 HD093754 annually in Study 2. We anticipate that this measurement study will provide critical guidance for future efficacy and effectiveness trials. Our goals are in line with the programmatic objective of the INCLUDE project to assemble a large cohort of individuals, perform deep phenotyping, and study co-existing conditions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $916,624 )
2025	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	7	6/30/2025	NON-COMPETING CONTINUATION	$916,624
2025	2022	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	5	2/13/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $916,624

Issue Date FY: 2024 ( Subtotal = $1,000,212 )
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	6	9/19/2024	COMPETING CONTINUATION	$1,000,212
														Subtotal = $1,000,212

Issue Date FY: 2022 ( Subtotal = $499,849 )
2022	2022	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	5	8/17/2022	NON-COMPETING CONTINUATION	$499,849
														Subtotal = $499,849

Issue Date FY: 2021 ( Subtotal = $529,166 )
2021	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	4	7/19/2021	NON-COMPETING CONTINUATION	$529,166
														Subtotal = $529,166

Issue Date FY: 2020 ( Subtotal = $870,052 )
2020	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	3	6/23/2020	NON-COMPETING CONTINUATION	$0
2020	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	3	6/17/2020	NON-COMPETING CONTINUATION	$870,052
														Subtotal = $870,052

Issue Date FY: 2019 ( Subtotal = $906,484 )
2019	2019	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	2	9/20/2019	SUPPLEMENT FOR EXPANSION	$406,082
2019	2019	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	2	5/30/2019	NON-COMPETING CONTINUATION	$500,402
														Subtotal = $906,484

Issue Date FY: 2018 ( Subtotal = $564,813 )
2018	2018	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	1	7/20/2018	NEW	$564,813
														Subtotal = $564,813

Grand Total All Awards = $5,287,200

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Cognitive Outcome Measures in School Age Children with Down Syndrome (ECODS)

Award Number: R01HD093754

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/20/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2029

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