Gathering Evidence for Patient-Informed Clinical Care of Early Female Puberty

/ABSTRACT The proposed project for a K23 Career Development Award will enable Dr. Camilia Kamoun to become an independent physician-scientist expert in patient-centered research on psychosocial health in early female puberty. Early female puberty is increasingly common, yet there is a lack of patient-centered tools to assess its psychosocial impact and guide treatment decisions. The proposed research aims to develop a patient-oriented outcomes (PROs) measure for early puberty, addressing a critical gap in evidence-based, patient-centered care. This research would positively impact public health given high rates of early puberty. Dr. Kamoun’s long- term goal is to become an expert in researching psychosocial health in pediatric patients with endocrine conditions, integrating bioethical inquiry to advance just, patient-centered care. Her strong research background, as well as bioethics training, make her an ideal candidate. The research has the following specific aims: 1) To characterize parental health concerns related to early female puberty, as well as parental experiences of its social and mental health impacts; 2) To understand parental prioritization of patient-reported health outcomes for early female puberty and explore their association with parental and child traits; and 3) To assess early female puberty-related PROs using adapted existing relevant PROMIS® measures. These aims will be accomplished through integrated mixed methods. They will lead to the development of a patient- oriented outcomes measure to use in a clinical trial to assess the effect of pubertal suppression treatment on psychosocial health in early female puberty, which will constitute the next steps in the research. In the last two years of the K23, Dr. Kamoun will develop an R01 or equivalent proposal to secure funding for this follow-up research. An interdisciplinary team of mentors and collaborators will guide Dr. Kamoun in accomplishing the following training goals: 1) To acquire advanced theoretical and practical knowledge of research methodologies used in patient-centered research; 2) To gain skills and knowledge in patient-oriented health outcomes research; 3) To acquire knowledge in peripubertal psychoneuroendocrinology and developmental psychology; 4) To deepen her bioethics expertise with a focus on pediatric, research, women’s health ethics, and the relationship between risks, values and ethical care. This training will include survey science coursework through the Odum Institute for Research in Social Science at UNC-CH and advanced bioethics training through the Children's Mercy Bioethics Center's Certificate Program in Pediatric Bioethics. Dr. Kamoun’s mentorship team will meet regularly with her to monitor progress, as well as to provide guidance in writing manuscripts and R01 and equivalent grant proposals. This K23 Career Development Award will provide Dr. Kamoun with the necessary training, mentorship, and research foundation to launch an innovative patient- centered research program that aligns with the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s mission to improve child and adolescent health and the transition to adulthood. Project Number: 1K23HD118189-01A1 | Fiscal Year: 2026 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Camilia Kamoun | Institution: UNIV OF NORTH CAROLINA CHAPEL HILL, CHAPEL HILL, NC | Award Amount: $172,623 | Activity Code: K23 | Study Section: Special Emphasis Panel[ZRG1 CCHI-N (52)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1K23HD11818901A1