Health and psychosocial outcomes in young children with cleft palate

Active Cooperative Agreement Awarded Last action

Award ID
U01DE030065
Recipient
Awarding agency
Obligated
$7,753,339

Award facts

Assistance listing
93.121 Oral Diseases and Disorders Research
Completion date 87% complete
Originally
Funding
  • $6,977,978.00 Federal
  • $775,361.00 Non-federal
Place of performance
Columbus, OH 43205, USA

Award details come from USAspending.gov.

Description

Abstract
Orofacial clefts are among the most common congenital conditions in the U.S., occurring in approximately one in every 800 births. Children with cleft palate with or without cleft LIP (CP±l) require interdisciplinary care from infancy through adulthood to improve speech, facial appearance, and physical and psychosocial health. Cleft- related treatments are burdensome for affected children and their families, and lifetime healthcare costs are estimated at nearly $700 million U.S. Dollars annually. Treatment guidelines for children CP± l are primarily based on clinical expertise and provide wide latitude in the types and timing of assessments and interventions. Although the american cleft palate-craniofacial association recommends that all cleft teams include a psychosocial professional to address the mental health, quality of life, emotional, behavioral, and social needs of children with CP±l, the types of services vary greatly across centers. In addition, IT remains unknown which children with CP±l are at greatest risk for poor health and psychosocial outcomes and which demographic (e.g., race), medical (e.g., cleft type, timing of diagnosis) and contextual factors (e.g., caregiver stress) contribute to these risks. Consequently, there is limited evidence to inform the provision of timely and effective interventions to support the long-term mental and physical health of children with CP±l and their families. This project will address this GAP by partnering with the cleft palate registry/research outcomes network (cornet; nidcr R01DE02749). Cornet is the largest U.S. Prospective study in cleft care to date and focuses on surgical and speech outcomes (pre-palate repair through 3 years of age) in a cohort of infants (n = 1514) with CP±l across 16 geographically diverse cleft centers. Leveraging cornet and an interdisciplinary team of investigators with expertise in cleft care outcomes, we propose to evaluate psychosocial and health outcomes in young children with CP±l and their caregivers through two new studies: 1) a cross-sectional study [n = 500] of medical and demographic factors predictive of health and psychosocial outcomes; and 2) a longitudinal, mixed methods study [n = 200] to evaluate contextual predictors of psychosocial and health outcomes over time. Specific aims include: 1) examine associations between medical and demographic factors and health (growth/BMI) and psychosocial outcomes (child health-related quality of life, adjustment) in children ages 2-5 years enrolled in cornet; 2) prospectively assess the impact of contextual risk and protective factors on health and psychosocial outcomes over time (at baseline/pre-palate surgery, 24 months, and 36 months of age); and 3) qualitatively evaluate caregiver perceptions of health and psychosocial outcomes and treatment experiences over time through narrative interviews with 40 caregivers. Data from this study will elucidate early predictors of poor and optimal outcome trajectories and inform both the type and timing of interventions to ensure that all children born with CP±l achieve optimal health and well-being.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $638,862 $0
Amendment $651,426 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $681,734 $0
Amendment $681,734 $0
Amendment $681,734 $0
Amendment $681,734 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $705,016 $0
Amendment $705,016 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $775,361 $0
Original award $775,361 $775,361
Show all 34

Subawards

Subrecipient Amount Awarded
Children's Hospital LOS Angeles 1) Examine associations between baseline caregiver and child demographic and clinical characteristics and physical and psychosocial outcomes for children at… $259,650
The University Of Iowa Obtain and maintain IRB approval and report adverse events as required. Designate study research assistant (s) (RA), and train and supervise the RA in… $80,971
University Of The West Of England, Bristol Leveraging the Cleft Palate Registry and Research Outcomes Network (CORNET) registry and an interdisciplinary team of investigators, this study will evaluate… $47,350
University Of Utah interdisciplinary team of investigators, this study will evaluate psychosocial and physical health outcomes in young children with cleft palate with or… $264,249
Seattle Children's Hospital Obtain and maintain IRB approval and report adverse events as required. Designate study research assistant (s) (RA), and train and supervise the RA in… $241,874
The Children's Hospital Of Philadelphia Obtain and maintain IRB approval and report adverse events as required. Designate study research assistant (s) (RA), and train and supervise the RA in… $192,469
Phoenix Children's Hospital, Inc. 1) Examine associations between baseline caregiver and child demographic and clinical characteristics and physical and psychosocial outcomes for children at… $186,088

Quick answers

Who received award U01DE030065?

U01DE030065 was awarded to Research Institute At Nationwide Children's Hospital by National Institute of Dental and Craniofacial Research (National Institutes of Health) on August 1, 2021.

How much is award U01DE030065 worth?

$7,753,339 has been obligated on U01DE030065: $6,977,978 in federal funding and $775,361 in non-federal funding.

On GovTribe

See this award's full record

  • Every transaction and subaward
  • The recipient's other awards and teaming partners
  • Similar grant awards
  • Ask GovTribe AI about this award