Preliminary Validation of the Psychosocial Assessment Tool in the Neonatal Intensive Care Unit.

OBJECTIVE: Research suggests families whose infants are admitted to the Neonatal Intensive Care Unit (NICU) experience elevated distress and may have pre-existing risk factors for maladjustment. This study sought to validate the newly developed Psychosocial Assessment Tool (PAT-NICU/Cardiac Intensive Care Unit [CICU]), a comprehensive screening measure for family psychosocial risk in the NICU. METHODS: The sample included 171 mothers, who completed the PAT-NICU/CICU and other related measures within 2 weeks of their infant's NICU admission at a level 4 unit within a large pediatric hospital. PAT-NICU/CICU scores were compared to a companion risk survey completed by NICU social workers. Test-retest reliability was assessed through repeated measures at 2-month follow-up. RESULTS: Analyses suggest the PAT-NICU/CICU is effective in classifying psychosocial risk. This is supported by statistically significant correlations between the PAT-NICU/CICU and validated measures, in addition to elevated scores on concurrent measures by risk classification. Internal consistency, test-retest reliability, and acceptability for the PAT-NICU/CICU were satisfactory. CONCLUSIONS: This preliminary study demonstrates the validity, reliability, and acceptability of the PAT-NICU/CICU as a psychosocial screening tool to aid identification of families who may benefit from supportive services during NICU admission. This new measure is a more comprehensive tool that assesses a wide variety of risk factors and stress responses. However, future studies of this measure are needed with more diverse samples. Prompt screening of NICU parents may facilitate earlier linkage with appropriate levels of resources or intervention. This research is crucial in improving risk assessment and psychosocial care for families in the NICU.

A biopsychosocial model of NICU family adjustment and child development.

BACKGROUND: Although infants in Neonatal Intensive Care Units (NICU) are at risk for developmental impairments and parents are at risk for emotional distress, factors that explain outcomes remain unknown. Here, we developed the first biopsychosocial model to explain family adjustment after NICU discharge. METHODS: Participants included 101 families at The Children's Hospital of Philadelphia Neonatal Follow-Up Program who had been discharged 1.5-2.5 years prior. We gathered data using validated assessments, standardized assessments, and electronic medical records. RESULTS: Our structural equation model, informed by the Double ABC-X Model, captured the dynamic relationships among infant, parent, couple, and family factors. Infant medical severity, posttraumatic stress, couple functioning, and family resources (e.g., time, money) were key for family adjustment and child development. CONCLUSIONS: Interventions that target parental posttraumatic stress, couple dynamics, parental perception of time for themselves, and access to financial support could be key for improving NICU family outcomes.

Parental mental health screening in the NICU: a psychosocial team initiative.

OBJECTIVE: About 40-50% of parents with children admitted to Neonatal Intensive Care Units (NICU) experience clinically significant levels of depression, anxiety, and trauma. Poor parental mental health can negatively influence parent-child interactions and child development. Therefore, early identification of parents at-risk for clinical distress is of paramount importance. METHODS: To address this need, the psychosocial team, including psychology and psychiatry, at a large, level 4 Neonatal Intensive Care Unit (NICU) developed a quality-improvement initiative to assess the feasibility of screening parents and to determine rates of depression and trauma in the unit. RESULTS: About 40% of mothers and 20% of fathers were screened between 2 weeks of their child's hospitalization. About 40-45% of those parents endorsed clinically significant levels of depression and anxiety symptoms. CONCLUSIONS: Recommendations for enhancing the feasibility and effectiveness of this process are discussed and considerations for future clinical and research endeavors are introduced.

The rise of tele-mental health in perinatal settings.

We discuss the use of tele-mental health in settings serving expectant parents in fetal care centers and parents with children receiving treatment in neonatal intensive care units within a pediatric institution. Our emphasis is on the dramatic rise of tele-mental health service delivery for this population in the wake of the onset of the COVID-19 pandemic in the U.S., including relevant practice regulations, challenges and advantages associated with the transition to tele-mental health in these perinatal settings.

Infant illness severity and family adjustment in the aftermath of NICU hospitalization.

Up to 15% of parents have an infant who will spend time in a neonatal intensive care unit (NICU). After discharge, parents may care for a medically fragile infant and worry about their development. The current study examined how infant illness severity is associated with family adjustment. Participants included parents with infants who had been discharged from the NICU 6 months to 3 years prior to study participation (N = 199). Via a Qualtrics online survey, parents reported their infants' medical history, parenting stress, family burden, couple functioning, and access to resources. Multivariable regression analyses revealed that more severe infant medical issues during hospitalization (e.g., longer length of stay and more medical devices) were associated with greater family burden, but not stress or couple functioning. Infant health issues following hospitalization (i.e., medical diagnosis and more medical specialists) were associated with greater stress, poorer couple functioning, and greater family burden. Less time for parents was associated with increased stress and poorer couple functioning. Surprisingly, parents of infants who were rehospitalized reported less stress and better couple functioning, but greater family burden. Family-focused interventions that incorporate psychoeducation about provider-patient communication, partner support, and self-care may be effective to prevent negative psychosocial sequelae among families.

Hasta un 15% de progenitores tiene un infante que pasará un tiempo en una Unidad de Cuidado Intensivo Neonatal (NICU). Después de la salida, los progenitores deben cuidar de un infante médicamente débil y preocuparse por su desarrollo. El presente estudio examinó cómo la severidad de la enfermedad del infante se asocia con la adaptabilidad familiar. Los participantes eran progenitores con infantes que habían salido de la Unidad de Cuidado Intensivo Neonatal entre 6 meses y 3 años antes de participar en el estudio (N = 199). Por medio de una encuesta electrónica tipo Qualtrics, los progenitores reportaron el historial médico de su infante, el estrés de la crianza, la carga familiar, el funcionamiento como pareja y el acceso a recursos. Los análisis de regresión de variables múltiples revelaron que asuntos médicos más severos del infante durante la hospitalización (v.g. período más largo de hospitalización, más aparatos médicos) se asociaban con mayor carga familiar, aunque no así con estrés o el funcionamiento como pareja. Los asuntos de salud infantil posteriores a la hospitalización (v.g. diagnóstico médico, más médicos especialistas) se asociaron con mayor estrés, un más pobre funcionamiento como pareja y mayor carga familiar. Menos tiempo para los progenitores se asoció con un aumento en el estrés y un más pobre funcionamiento como pareja. De modo sorprendente, los progenitores de infantes que habían sido hospitalizados otra vez reportaron menos estrés y mejor funcionamiento como pareja, pero mayor carga familiar. Las intervenciones con enfoque familiar que incorporan educación sicológica acerca de la comunicación entre proveedor y paciente, apoyo a la propia pareja y el cuidado propio pudieran ser eficaces para prevenir la secuela sicosocial entre familias.

Jusqu'à 15% des parents ont un bébé qui passera du temps en Unité Néonatale de Soins Intensifs. A la sortie de l'hôpital les parents peuvent se retrouver à prendre soin d'un bébé fragile du point de vue médical et s'inquiéter de son développement. Cette étude a examiné comment la sévérité de la maladie du bébé est liée à l'ajustement de la famille. Les participants ont inclu des parents avec des bébés étant sortis de l'Unité Néonatale de Soins Intensifs 6 mois à trois ans avant la participation à l'étude (N = 199). Au travers d'un questionnaire Qualtrics en ligne, les parents ont fait état de l'histoire médicale des bébés, du stress de parentage, du poids sur la famille, du fonctionnement du couple et de l'accès aux ressources. Des analyses de régression multivariables ont révélé que les problèmes médicaux du bébé durant l'hospitalisation les plus graves (i.e. durée plus longue du séjour, plus de dispositifs médicaux) étaient liés à un poids sur la famille plus fort, mais pas au stress ni n'affectait le fonctionnement du couple. Les problèmes de santé du bébé après l'hospitalisation (soit un diagnostic médical, plus de spécialistes médicaux) étaient liés à un stress plus élevé, à un fonctionnement du couple moins bon, et à un poids sur la famille plus fort. Moins de temps pour les parents était lié à un stress supplémentaire et à un fonctionnement du couple moins bon. Avec surprise, les parents de bébés qui étaient réhospitalisés ont fait état de moins de stress et d'un meilleur fonctionnement de couple, mais d'un poids plus fort sur la famille. Les interventions centrées sur la famille qui incorporent une psychoéducation sur la communication médecin-parent, le soutien du partenaire et le soin de soi peut s'avérer efficace afin d'éviter des séquelles psychosociales négatives chez les familles.

Utilization of NICU Infant Medical Indices to Classify Parental Risk for Stress and Family Burden.

INTRODUCTION: This study was conducted to examine whether the parental report of objective infant medical indices (e.g., birth weight, length of stay) can be used to identify parents at risk for psychosocial sequelae. METHODS: Parents (N = 199) cohabitating with their partner and child who was discharged from a neonatal intensive care unit (NICU) 6 months to 3 years prior to the administration of the study completed an online survey, which included parent-reported infant health, parenting stress, family burden, and family resources. RESULTS: A hierarchical cluster analysis identified the following three clusters of parents at risk for stress and family burden as determined by infant medical severity and access to resources: lowest risk (n = 77), moderate risk (n = 68), and highest risk (n = 8). DISCUSSION: This work highlights how a measure using parent-reported infant health severity, which was developed for this study, can be used to better understand family outcomes following NICU hospitalization.

Maternal depression, anxiety, stress, and maternal-infant attachment in the neonatal intensive care unit.

OBJECTIVE: The objectives of this study were to identify maternal psychological responses to infants' neonatal intensive care unit (NICU) admission, understand the relationship between psychological symptoms and maternal-infant attachment, and evaluate change in psychological symptoms over time. BACKGROUND: Accumulating evidence suggests that infants' admission to a NICU may adversely impact maternal psychiatric functioning. NICU mothers typically experience high levels of depressive, anxiety, and stress symptoms. METHODS: Mothers (N = 127) recruited from their infants' NICU bedside at three hospitals in the Philadelphia area completed self-report measures of depression, anxiety, stress, and maternal-infant attachment during the NICU admission and then 2-4 months later. A series of bivariate correlations, paired samples t-tests, and linear regression analyses were used to evaluate the primary study aims. RESULTS: NICU mothers reported elevated rates of depressive, anxiety, and stress symptoms. Maternal-infant attachment was negatively associated with anxiety and stress symptoms. Both depressive and anxiety symptoms were higher during NICU admission compared to 2-4 months later, and depressive symptoms during NICU admission predicted depressive symptoms 2-4 months later. CONCLUSIONS: This study demonstrates that NICU admission may heighten maternal risk for psychiatric symptoms, and maternal-infant attachment in the NICU may be an important correlate of maternal anxiety and stress symptoms.

Parental Attitudes Towards Prenatal Genetic Testing For Sickle Cell Disease.

Uptake of prenatal genetic testing (PGT) is low among those with sickle cell disease (SCD). This study evaluated the association of knowledge and attitudes towards prenatal genetic counseling (PGC), awareness of posttesting intervention options and omission bias with attitudes towards PGT. In addition, we explored changes among knowledge, attitudes, and awareness of options following exposure to an educational, clinical vignette among parents of children with SCD. Parents (n=44) completed a questionnaire and an educational, clinical vignette presenting a detailed account of a pregnant woman with sickle cell trait seeking PGT and PGC was read to each participant. t Tests, Spearman correlations, multivariable regressions, and moderation/mediation analyses were used. More positive attitudes towards PGC (P=0.01), lesser tendency of omission bias (P<0.01) and private insurance (P=0.04) were significant correlates of more positive attitudes towards PGT. Omission bias mediated the relationship of attitudes towards PGC and attitudes towards PGT (95% confidence interval: 0.13, 3.03). Awareness of options (P=0.02), knowledge of PGC (P=0.01) and knowledge of PGT (P=0.01) significantly improved after exposure to the clinical vignette. Patients and families with SCD can benefit from education about the importance of prenatal diagnosis to improve attitudes, address omission bias and promote more informed decisions of PGT.

Development and Pilot Testing of a Coping Kit for Parents of Hospitalized Children.

OBJECTIVE: Serious pediatric illness places great stress on families. Parents who learn coping skills may better manage these stressors. This study sought to develop and refine a stress coping intervention for parents of hospitalized children, assess the intervention acceptability among these parents, and gather preliminary data on stress, negative and positive affect, anxiety, depression, and self-efficacy. METHODS: We conducted an observational study in 2 phases, enrolling parents of children who were inpatients with serious illness, 10 in Phase 1 and 40 in Phase 2. All parents completed at baseline measures of stress and psychological well-being and were introduced to the Coping Kit for Parents. Follow-up interviews were conducted at 1 week (all parents) and 1 month (Phase 2 parents only) regarding the acceptability of the intervention. RESULTS: At baseline, parents reported that stressful situations were frequent (mean = 30.6, standard deviation [SD] = 6.8) and difficult (mean = 26.2, SD = 7.1) and revealed elevated levels of negative affect (mean = 27.3, SD = 7.7), depression (mean = 8.5, SD = 3.7), and anxiety (mean = 11.3, SD = 3.1) and moderate levels of self-efficacy related to their child's illness (mean = 3.3, SD = 0.5). The majority of parents used the kit regularly and on a scale of 1 to 7 agreed that the kit was helpful (mean = 6.0, SD = 0.9), interesting (mean = 5.7, SD = 1.3), practical (mean = 5.7, SD = 1.4), enjoyable (mean = 6.0, SD = 1.3), and they would recommend it to other parents (mean = 6.4, SD = 0.9). CONCLUSIONS: The Coping Kit for Parents is an acceptable stress management intervention that could be made available to parents of children with serious illness at pediatric hospitals with minimal staff training or time commitment.

NICU infant health severity and family outcomes: a systematic review of assessments and findings in psychosocial research.

Many infants (7-15%) spend time in the neonatal intensive care unit (NICU) and continue to experience medical issues after discharge. Family psychological responses range widely depending on burden of care, access to resources, and parental characteristics. The current systematic review examined how infant health severity is assessed and related to family psychological (e.g., mental health) and social (e.g., parent-infant attachment) outcomes. Seventy articles were deemed relevant. Infant health was operationalized in several ways including validated assessments, indices of infant health (e.g., diagnosis, length of stay), or novel measures. Parents of infants with increased medical complications reported greater family impact, increased stress, and more intrusive parenting style. A validated assessment of infant health that utilizes parent report is warranted to allow for more accessible and easily disseminated research across medical centers. Understanding NICU infant health severity and family outcomes can be used to identify families at risk for negative psychosocial sequelae.

Family Functioning, Medical Self-Management, and Health Outcomes Among School-Aged Children With Sickle Cell Disease: A Mediation Model.

Background: Informed by the Pediatric Self-Management Model, the present study tested relationships between parent and family functioning, sickle cell disease (SCD) self-management, and health outcomes for children with SCD. Method: 83 children with SCD and a parent completed baseline data as part of a larger investigation of a family-based, problem-solving intervention for children with SCD (M age = 8.47). Youth and parents completed a measure of child health-related quality of life (HRQOL), and parents completed measures of family efficacy, parenting stress, and SCD self-management. SCD pain episodes and urgent health utilization information over the past year were obtained via medical chart review. Results: SCD self-management mediated the relationship between parent-reported family efficacy and parent proxy HRQOL, as well as the relationship between parenting stress and child and parent proxy HRQOL. Mediation models were nonsignificant for outcomes beyond HRQOL, including SCD pain episodes and urgent health utilization. Conclusion: Fostering family efficacy and reducing parenting stress may be meaningful intervention targets for improving SCD self-management and child HRQOL among school-aged children. Although findings were consistent with the Pediatric Self-Management Model in terms of HRQOL, the model was not supported for pain episodes or urgent health utilization, highlighting the need for multi-method, longitudinal research on the SCD self-management behaviors that are linked to preventable health outcomes.

Acceptability of In Utero Hematopoietic Cell Transplantation for Sickle Cell Disease.

BACKGROUND: In utero hematopoietic cell transplantation (IUHCT) has curative potential for sickle cell disease (SCD) but carries a risk of fetal demise. METHODS: We assessed the conditions under which parents of children with SCD and young adults with SCD would consider IUHCT in a future pregnancy, given a 5% fixed risk of fetal demise. Participants were randomized to consider a hypothetical cure rate (20%, 40%, or 70%). Subsequently, cure rate was either increased or decreased depending on the previous answer to reveal the lowest acceptable rate. Participants also completed the Pediatric Research Participation Questionnaire (PRPQ) and an omission scale. RESULTS: Overall, 74 of 79 (94%) participants were willing to consider IUHCT, and 52 (66%) participants accepted IUHCT at a cure rate of 40%, the estimated rate of therapeutic mixed chimerism. Participants with higher scores on the PRPQ perceived benefits scale were more likely to participate at lower cure rates (OR 1.08, p=0.007) and participants with a greater degree of omission bias were less likely to participate at lower cure rates (OR 0.83, p=0.04). Demographics and SCD severity were not significantly associated with acceptability of IUHCT. CONCLUSION: This study suggests that the majority of parents >and young adults would consider IUHCT under expected therapeutic conditions.

Mistrust of Pediatric Sickle Cell Disease Clinical Trials Research.

INTRODUCTION: Sickle cell disease (SCD) research is hampered by disparities in participation due in part to mistrust of research among racial/ethnic minorities. Beyond the historic context of research misconduct, little is known about the associations of social ecologic factors with mistrust and of mistrust with SCD clinical trials enrollment. This study evaluated proximal (age, gender, disease severity, perceived stress, SES) and distal (religious beliefs, social support, instrumental support) factors related to mistrust of research among caregivers of children with SCD and adolescents and young adults (AYAs) with SCD. METHODS: Over an 18-month period (2009-2010), participants completed questionnaires of perceived barriers and benefits to clinical trials enrollment, perceived stress, and self-reported demographic and disease-related information. Analyses (January-June 2015) used multivariable linear regressions to evaluate predictors of mistrust. RESULTS: Data were analyzed for 154 caregivers (mean age, 38.75 years; SD=9.56 years; 90.30% female) and 88 AYAs (mean age, 24.76 years; SD=7.25 years; 46.40% female). Among caregivers (full model, R(2)=0.14, p≤0.001), greater mistrust was explained by higher perceived stress (ß=0.04, p=0.052); religious beliefs (ß=0.61, p≤0.001); and greater instrumental support (ß=0.07, p=0.044). Among AYAs (full model, R(2)=0.18, p≤0.001), higher mistrust was explained by being male (ß=-0.56, p≤0.001) and lower instrumental support (ß=-0.11, p=0.016). Mistrust was significantly greater among caregivers that reported no prior involvement in medical research (p=0.003). CONCLUSIONS: By understanding the complexity through which social ecologic factors contribute to mistrust, researchers may create targeted strategies to address mistrust and increase engagement in SCD research for caregivers and AYAs.

Training Pediatric Psychologists for Perinatal Behavioral Health Services in a Pediatric Hospital.

Although pediatric hospitals specialize in providing care to children and adolescents, at The Children's Hospital of Philadelphia (CHOP), our team has been providing behavioral health services for two unique parent populations-parents with a child in the Newborn Infant Intensive Care Unit and pregnant women carrying fetuses with specific birth defects and receiving prenatal care in the Center for Fetal Diagnosis and Treatment. A new training program was developed to expand the scope of pediatric psychologists' practice to include perinatal behavioral health services, specifically for these two unique parent populations served at CHOP. The program includes direct service provision for adult mental health concerns, as well as education and support to help families cope with the existing medical conditions. This article describes the training program and its implementation as a model of training for other pediatric hospitals. The roles of psychologists embedded in these units and hospital privileges are discussed.

Lessons Learned From a Randomized Controlled Trial of a Family-Based Intervention to Promote School Functioning for School-Age Children With Sickle Cell Disease.

OBJECTIVE: Tested a family-based group problem-solving intervention, "Families Taking Control," (FTC) to improve school functioning and health-related quality of life (HRQL) for children with sickle cell disease. METHOD: Children and caregivers completed questionnaires assessing HRQL and school functioning and children completed performance-based measures of IQ and achievement at baseline and 6 months later. Families were randomized to the intervention (FTC, n = 42) or delayed intervention control (DIC, n = 41) group. FTC involved a full-day workshop followed by 3 booster calls. RESULTS: There were no differences between FTC completers (n = 24) and noncompleters (n = 18). FTC group (n = 24) and DIC group (n = 38) did not differ significantly on primary outcomes at follow-up: number of formal academic and disease-related accommodations, individualized education plan/504 service plan, school absences, school HRQL, or academic skills. CONCLUSIONS: Although families found FTC to be acceptable, there were no intervention effects. Challenges of the trial and implications for future research are discussed.

Clinical Trial Decision Making in Pediatric Sickle Cell Disease: A Qualitative Study of Perceived Benefits and Barriers to Participation.

Clinical trial research forms the foundation for advancing treatments; yet, children with sickle cell disease (SCD) are currently underrepresented. This qualitative study examines decision-making processes of youth with SCD and their caregivers regarding enrollment in clinical trial research. A subsample of participants from a study of clinical trial decision making among youth with health disparity conditions, 23 caregivers and 29 children/teens/young adults with SCD (age, 10 to 29 y), indicated whether or not they would participate in hypothetical medical and psychosocial clinical trials and prioritized barriers and benefits to participation via card sort and semistructured interviews. Audio recordings were transcribed and coded for themes. Participants reported that concerns of potential harm most affected their decision. Secondary factors were potential benefit, manageable study demands, and trust in the medical staff. Caregivers weighed potential harm more heavily than their children. Young children were more likely to endorse potential benefit. Overall, participants stated they would be willing to participate in research if the potential benefit outweighs potential harm and unmanageable study demands. To optimize recruitment, results suggest addressing potential harm first while highlighting potential benefits, creating manageable study demands, and endorsing the future benefits of research to the sickle cell community.

Parental problem-solving abilities and the association of sickle cell disease complications with health-related quality of life for school-age children.

Children with sickle cell disease (SCD) are at risk for poor health-related quality of life (HRQOL). The current analysis sought to explore parent problem-solving abilities/skills as a moderator between SCD complications and HRQOL to evaluate applicability to pediatric SCD. At baseline, 83 children ages 6-12 years and their primary caregiver completed measures of child HRQOL. Primary caregivers also completed a measure of social problem-solving. A SCD complications score was computed from medical record review. Parent problem-solving abilities significantly moderated the association of SCD complications with child self-report psychosocial HRQOL (p = .006). SCD complications had a direct effect on parent proxy physical and psychosocial child HRQOL. Enhancing parent problem-solving abilities may be one approach to improve HRQOL for children with high SCD complications; however, modification of parent perceptions of HRQOL may require direct intervention to improve knowledge and skills involved in disease management.

Predictors of Academic Achievement for School Age Children with Sickle Cell Disease.

BACKGROUND: Children with sickle cell disease (SCD) are at risk for neurocognitive impairment and poor academic achievement, although there is limited research on factors predicting academic achievement in this population. This study explores the relative contribution to academic achievement of a comprehensive set of factors, such as environmental (socioeconomic status), disease-related (stroke, transfusion therapy, adherence), and psychosocial variables (child behavior, child quality of life (QoL)), controlling for intellectual functioning (IQ). METHODS: Eighty-two children with SCD completed measures assessing IQ and academic achievement, while parents completed questionnaires assessing adherence, child behavior, and child quality of life. Medical chart reviews were conducted to determine disease-related factors. RESULTS: Hierarchical regression analyses indicated that 55% of the variance in academic skills was accounted for by IQ, parent education, chronic transfusion status, and QoL [R2 = .55, F(5, 77) = 18.34, p < .01]. Follow-up analyses for broad reading [R2 = .52, F(5, 77) = 16.37, p < .01], and math calculation [R2 = .44, F(5, 77) = 12.14, p < .01] were also significant. CONCLUSION: The findings suggest a significant contribution of factors beyond IQ to academic achievement. Findings allow for identification of children with SCD at risk for academic difficulties for whom psychoeducational interventions may enhance academic achievement.

Initial development of a questionnaire evaluating perceived benefits and barriers to pediatric clinical trials participation.

OBJECTIVE: To evaluate perceived benefits and barriers to pediatric clinical trials participation to improve decision-making and enhance recruitment and retention among minority youth with chronic health conditions (sickle cell disease, asthma) and their caregivers. METHODS: A questionnaire was developed based on the social ecological model using input from medical experts and community-based public health organizations. Parallel caregiver, adolescent/young adult (AYA; 16-39 years old), and child (8-15 years old) versions were field tested. Patients and caregivers completed the questionnaire, which included demographic items, perceived life stress and social desirability measures. RESULTS: Exploratory factor analysis rendered a four-factor solution for the caregiver version (direct treatment benefit, mistrust of research/researchers, trust in healthcare team to engage in safe research, and opportunity cost) and the AYA version (mistrust/no direct benefit, safety, direct treatment benefit/practical considerations, and social support for research). Factor structures differed for SCD and asthma caregivers; results were equivocal for the child version. Summated subscales were not significantly associated with patient demographics or social desirability, but significant correlations with perceived life stress and prior participation in research were identified. CONCLUSIONS: While the factor structure should be confirmed with larger samples, findings indicate potential benefit, perceived harm due to mistrust of researchers, and logistics are primary factors in decision-making about participation in pediatric clinical trials. By addressing these benefits/barriers through adjustments to recruitment and informed consent procedures, researchers may address misperceptions of research, improve decision-making, and increase recruitment and retention particularly for ethnic minority children with chronic health conditions.