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APPLES: Early Childhood Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy

Award Number: R01HD081120
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT Long-term goals of this application are to develop safe, effective, and scalable interventions with a strong basis in neuroscience, to improve the upper extremity (UE) function of children with cerebral palsy (CP). Our UE intervention called “APPLES” is parent-administered, medical team-directed, uses soft constraint and “sticky-mittens” and bimanual therapy. Our first R01 showed that it effectively improved UE function, cortical somatosensory processing, and reach smoothness, while being safe for the developing brain and body in infants (6-24 months) with CP. Our competing renewal addresses remaining gaps in knowledge: is there an earliest age at which APPLES is most effective, can APPLES be successfully delivered through telehealth, and because parents are delivering APPLES, are there evidence-based supports that we can offer them to be more effective, and do all parents need these supports equally. We also specifically address new NCMRR priorities for: (1) “multimodal approaches that promote plasticity and sensorimotor function”, (2) “patient-reported outcomes as ... secondary endpoints in trials”, and (3) “development of scalable strategies”. We call our new intervention APPLES-tele, as it will be delivered through telehealth and start in infants as young as 3 months. In addition, we test the relative efficacy of APPLES-tele vs. standard care group and vs. a novel parent-centered approach (PCA) that is infant- and CP-specific. PCA consists of education in infant motor learning, adaptive strategies for CP, and positive psychology in parenting (from the scientifically-proven Triple P Positive Parenting Program model). PCA will help parents develop “authoritative parenting”, an optimal parenting style proven to promote better long-term developmental outcomes. The design is a randomized controlled trial with both business-as-usual and active treatment comparisons; two groups receive PCA and APPLES-tele, but in different order. The other receives standard care. Both 6- week interventions will have the same weekly-telehealth schedule. Assessments are at baseline, at 6- weeks and 12 weeks. We use standardized tests of hand function and development, validated measures of parent-treatment fidelity, and parent-relevant measures of performance. Interventions and assessments are protocolized and monitored to ensure rigor and reproducibility. We leverage a large cohort of parents and children across 4 centers already linked through our successful implementation network for early detection of CP, with diverse socioeconomic and geographic conditions in an area > 11% of the US. We aim to demonstrate improvements in UE function are greater in the APPLES-tele-first group than in both control groups after the first 6-weeks of intervention. Conversely, we will show parent CP-specific knowledge and parent-child emotional connection are greater in the PCA-first group than the other 2 groups. We will then explore whether relative efficacy of PCA-then-APPLES vs. APPLES-then-PCA on infants’ UE function across the entire 12 weeks depends on initial level of authoritative parenting.


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: 2023 ( Subtotal = $644,731 )
2023	2023	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Child Health and Human Development Extramural Research	001	8	9/7/2023	NON-COMPETING CONTINUATION	$644,432
2023	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	5	11/23/2022	NON-COMPETING CONTINUATION	$299
														Subtotal = $644,731

Issue Date FY: 2022 ( Subtotal = $648,219 )
2022	2022	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Child Health and Human Development Extramural Research	002	7	9/13/2022	NON-COMPETING CONTINUATION	$648,219
2022	2021	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Child Health and Human Development Extramural Research	001	6	6/29/2022	COMPETING CONTINUATION	$98,479
2022	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	5	6/29/2022	NON-COMPETING CONTINUATION	-$98,479
														Subtotal = $648,219

Issue Date FY: 2021 ( Subtotal = $727,115 )
2021	2021	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Child Health and Human Development Extramural Research	002	6	9/21/2021	COMPETING CONTINUATION	$727,115
2021	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	001	5	8/20/2021	NON-COMPETING CONTINUATION	$0
2021	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	5	5/5/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $727,115

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	5	5/29/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $507,230 )
2019	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	5	5/1/2019	NON-COMPETING CONTINUATION	$507,230
														Subtotal = $507,230

Issue Date FY: 2018 ( Subtotal = $518,867 )
2018	2018	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	4	5/15/2018	NON-COMPETING CONTINUATION	$518,867
														Subtotal = $518,867

Issue Date FY: 2017 ( Subtotal = $518,267 )
2017	2017	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	3	6/7/2017	NON-COMPETING CONTINUATION	$518,267
														Subtotal = $518,267

Issue Date FY: 2016 ( Subtotal = $534,517 )
2016	2016	Research Institute at Nationwide`s Children`s Hospital	700 CHILDREN`S DRIVE	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	2	4/29/2016	NON-COMPETING CONTINUATION	$534,517
														Subtotal = $534,517

Issue Date FY: 2015 ( Subtotal = $492,632 )
2015	2015	Research Institute at Nationwide`s Children`s Hospital	700 CHILDREN`S DRIVE	COLUMBUS	OH	43205	FRANKLIN	USA	Child Health and Human Development Extramural Research	000	1	8/18/2015	NEW	$492,632
														Subtotal = $492,632

Grand Total All Awards = $4,591,578

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APPLES: Early Childhood Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy

Award Number: R01HD081120

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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