Larry L. Mullins - US grants

DESCRIPTION (provided by applicant): The impact of pediatric cancer exerts system-wide influences, which places both children and their parents at risk for compromised adjustment from the time of diagnosis through survivorship. Parents serve as primary caregivers for their child following the diagnosis of pediatric cancer, and as such, they face substantial difficulties in not only adjusting to their child's diagnosis, but also in negotiating an arduous and lengthy treatment course. To date, only a handful of studies have sought to evaluate the benefits of comprehensive psychosocial interventions for parents of children with cancer. This emerging literature suggests that psychosocial interventions indeed have the potential to promote coping efforts and ameliorate psychological distress in parents, and that interventions taking place soon after the child's diagnosis may be superior to those that occur post-treatment. Thus, the current project is a pilot study that will assess the feasibility and acceptability of implementing a clinic-based interdisciplinary (psychology and nursing) intervention for parents of children newly diagnosed with cancer. Parents will be randomly assigned at baseline to either the interdisciplinary intervention group (IG) or the treatment as usual (TAU) group. The 6-module, 12-session interdisciplinary intervention will focus on teaching parents skills to help them manage their uncertainty. The intervention will alternate weeks with 6 in-clinic sessions delivered by a psychology clinician, coupled with 6 telephone sessions delivered by a nurse interventionist in between the clinic sessions. The current study is guided by the following primary aims: 1) to assess the feasibility and acceptability of implementing a 12-session, clinic-based, interdisciplinary intervention for parents of children newly diagnosed with cancer;2) to estimate effect sizes for the intervention in reducing parental psychological distress, posttraumatic stress symptoms (PTSS), caregiver burden, and illness uncertainty. Secondary, exploratory aims include: 1) to assess whether illness uncertainty mediates the effect of the intervention on parent psychological distress, PTSS, and caregiver burden;and 2) to assess whether the intervention exerts an indirect effect on the child's emotional and behavioral functioning. Parents will complete measures of psychological distress, PTSS, caregiver burden, illness uncertainty, and their child's emotional and behavioral functioning at three time points: baseline, and 1-month, and 3-months post-treatment. PUBLIC HEALTH RELEVANCE: The current study is an intervention designed to help reduce parents'distress associated with their child's recent diagnosis of cancer. The intervention will include the expertise of both psychologists and nurses in teaching parents skills to help manage their uncertainty about their child's illness.

DESCRIPTION (provided by applicant): Whether or not to surgically correct ambiguous genitalia to be more female- or male-typical with genitoplasty is an area of pediatric medicine that is highly controversial. Suboptimal outcomes such as poor post-surgical cosmesis and sexual dysfunction following outdated surgical procedures have driven intense controversy in the medical community over how, or if, genitoplasty should be used in the treatment of young children with ambiguous genitalia. To resolve this debate, a prospective study of outcomes of current genitoplasty procedures, including complication rates associated with these procedures, is needed of individuals who receive masculinizing or feminizing surgery during early childhood. Additionally, studies of parents who decide to proceed, or not, with genitoplasty for their young child are necessary to understand how these controversial decisions impact parents' reactions to surgical outcomes for their child. The overall goal of this proposal is to assess the outcomes of modern genitoplasty techniques with a consideration of the psychological outcome of parents who make the decisions to proceed with genital surgery for their child. This information is crucial for physicians to provide guidance to parents regarding the optimal approach for the management of ambiguous genitalia in young children, including the possibility that no surgery is best. The interdisciplinary group of clinicians and researchers included in the proposed studies spans the fields of psychology, statistics, pediatric endocrinology, and pediatric urology. The collective experience of our group optimizes our ability to translate findings from the proposed studies to a clinical setting in a timely manner.

Project Summary The birth of a child with ambiguous genitalia challenges societal beliefs about gender and ?normalcy?, and is both traumatizing and isolating for their parents and families. Parents are involved in making important medical decisions early in the child's life that can have long-lasting effects on the child's physical and emotional well- being. However, during the time of making these decisions parents are often affected by their own psychological distress and uncertainty about the child's diagnosis, which can potentially lead to hasty decision-making and poor long-term outcomes. The proposed project will utilize a mixed-methods research design, combining qualitative and quantitative research methods to ultimately develop an internet-delivered intervention to reduce uncertainty for parents of children with a Disorder of Sex Development (DSD). The study is guided by two aims: First, we will conduct qualitative interviews with parents of children with a DSD in order to better understand the aspects of the child's diagnosis, treatment, and prognosis that were previously and are currently triggering and maintaining elevated levels of uncertainty. Notably, we have an established consortium of 10 hospitals, all with specialized multi-disciplinary teams for the treatment of DSD, who are committed to participating in this study. As such, we will be able to obtain information from a wide range of parents in terms of race, ethnicity, and socioeconomic status. Second, we will analyze the qualitative data using thematic analyses and will use this information to develop a brief, 6-module internet-delivered intervention targeting the reduction of uncertainty. We will pilot-test this intervention with parents of children who have a new DSD diagnosis through any of the hospitals in our consortium, such that these parents will be participating in the study while going through the process of making these early medical decisions. We expect that parents who participate in the intervention will report lower levels of uncertainty and less psychological distress surrounding their child's diagnosis, which will allow them to make the best-informed medical decisions regarding their child's care, and ultimately result in better long-term outcomes for patients with DSD. The results of the proposed study will be used to develop a future, multisite, randomized controlled trial of the intervention.

PROJECT SUMMARY/ABSTRACT Whether or not to surgically ?correct? ambiguous genitalia in young children is an area of pediatric medicine that is highly controversial. Suboptimal outcomes such as poor cosmesis and sexual dysfunction following outdated surgical procedures have driven intense controversy in the medical community over how, or if, surgery should be used in the treatment of young children with ambiguous genitalia. To help resolve this debate, a prospective study of long-term outcomes of current surgical procedures, including complication rates associated with these procedures, is needed among individuals who receive masculinizing or feminizing surgery during early childhood. Additionally, studies of parents who decide to proceed, or not, with such surgeries for their young child are necessary to understand how these controversial decisions impact parents? reactions to their child. Finally, better understanding of cognitive, behavioral, and social development in children born with ambiguous genitalia, including identification of novel markers for predicting gender development, is needed. The overall goal of this proposal is to assess the outcomes of modern surgical techniques with a consideration of the psychological outcomes of affected children and their parents. This information is crucial for physicians to provide guidance to parents regarding the optimal approach for the management of ambiguous genitalia in young children, including the possibility that no surgery is best. The interdisciplinary group of clinicians and researchers included in the proposed studies span the fields of psychology, statistics, pediatric endocrinology, and pediatric urology. The collective experience of our group optimizes our ability to translate findings from the proposed studies to a clinical setting in a timely manner.