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Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome

Award Number: R61HD100934
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: 09/30/2019
PERIOD OF PERFORMANCE END DATE: 09/14/2022

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Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome - PROJECT SUMMARY Children with Down syndrome (DS) have a 3-5 times greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability (ID) and comorbid ADHD. Possible reasons for under-utilization of stimulant treatment in DS+ADHD include: 1) diagnostic uncertainty regarding how to accurately diagnose ADHD in children with DS, making providers prone to “diagnostic overshadowing” (i.e., attributing ADHD to the ID); 2) there is not a single clinical trial examining the safety and efficacy of stimulant medication in children with DS+ADHD; and 3) concerns about cardiac safety, given the high incidence of congenital heart disease or defects (CHD) in the DS population. We propose a pilot study to define the clinical features of DS+ADHD thereby enabling more accurate diagnosis and a pilot clinical trial to inform sample size estimates for a larger clinical trial. We propose to perform the first randomized clinical trial of stimulant medication in children with DS+ADHD to provide evidence regarding the short and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. One hundred (100) children with DS+ADHD and 70 children with DS and no ADHD (DS-ADHD), all aged 6-12 and matched on age, gender, and IQ, will participate. All 170 children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria as well as behavioral, cognitive, academic, and functional impairments. The 100 children in the DS+ADHD group will also complete a multi-phased randomized, double-blind clinical trial with crossover to placebo and long-term follow- up to assess the short- and long-term efficacy and safety of stimulant medications for treating ADHD symptoms and impairment in children with DS. Study aims will focus on 1) Identifying behavioral, cognitive, academic, and functional impairments that differentiate children with DS+ADHD from children with DS-ADHD; 2) Informing sample size of larger clinical trial; 3) Assessing the short- and long-term safety of stimulant treatment in children with DS+ADHD with a specific focus on cardiac safety; 4) Determining the short- and long-term efficacy of stimulant treatment at remediating cognitive, behavioral, and functional impairments in children with DS+ADHD; and 5) Exploring moderators (e.g., IQ, ADHD subtype, executive functioning, comorbid internalizing disorders, CHD) of stimulant response and side effects. Results from this study will provide much needed diagnostic and treatment data that will directly impact the outcomes of the approximately 45,000 children with DS+ADHD nationwide.


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: 2024 ( Subtotal = -$40,806 )
2024	2021	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Dietary Supplement Research Program	000	2	10/13/2023	SUPPLEMENT FOR EXPANSION	-$40,806
														Subtotal = -$40,806

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Dietary Supplement Research Program	001	2	5/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2020	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	2	5/10/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Dietary Supplement Research Program	001	2	9/13/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	2	9/13/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $164,639 )
2021	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Dietary Supplement Research Program	002	2	8/19/2021	SUPPLEMENT FOR EXPANSION	$164,639
2021	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	2	6/25/2021	NON-COMPETING CONTINUATION	$0
2021	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	2	8/18/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $164,639

Issue Date FY: 2020 ( Subtotal = $675,867 )
2020	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	2	8/25/2020	NON-COMPETING CONTINUATION	$675,867
2020	2019	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	1	1/17/2020	NEW	$0
														Subtotal = $675,867

Issue Date FY: 2019 ( Subtotal = $680,323 )
2019	2019	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	1	9/20/2019	NEW	$680,323
														Subtotal = $680,323

Grand Total All Awards = $1,480,023

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Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome

Award Number: R61HD100934

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: 09/30/2019

PERIOD OF PERFORMANCE END DATE: 09/14/2022

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