Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol.

BACKGROUND: Medication non-adherence is common among adolescents and young adults (AYAs) with cancer and associated with poor health outcomes. AYAs with cancer endorse multiple barriers to adherence that differ across individuals, suggesting that tailoring intervention content to an AYA's specific barriers may have the potential to improve adherence. The purpose of this manuscript is to report on ORBIT-guided Phase I design efforts to create the first tailored adherence-promotion intervention for AYAs with cancer and the study protocol for the ongoing Phase II pilot feasibility trial. METHODS: Phase I design included qualitative interviews (n = 15 AYAs) to understand patient preferences for adherence-promotion care, development and refinement of a best-worst scaling exercise barriers tool (n = 5 AYAs), and development of intervention modules and a tailoring algorithm. In the ongoing Phase II pilot feasibility trial, AYAs (ages 15-24 years) with cancer currently taking oral chemotherapy or prophylactic medication will be recruited from three children's hospitals. Feasibility, acceptability, and usability will be assessed and these outcomes along with data on medication adherence will be used to inform the next phases of intervention development and testing. CONCLUSIONS: If promising, this program of research ultimately has the potential to equip clinicians with additional strategies for supporting adherence among AYAs with cancer. NCT05706610.

Emotion coaching skills as an augmentation to family-based therapy for adolescents with anorexia nervosa: A pilot effectiveness study with families with high expressed emotion.

OBJECTIVE: To examine the feasibility and acceptability of augmenting family-based treatment (FBT) for adolescents with anorexia nervosa (AN) or atypical anorexia nervosa (AAN) with a parent emotion coaching intervention (EC) focused on reducing parent expressed emotion. METHOD: In this pilot effectiveness trial, families of adolescents with AN/AAN exhibiting high expressed emotion received standard FBT with either (1) EC group or (2) support group (an attention control condition focused on psychoeducation). RESULTS: Forty-one adolescents with AN or AAN were recruited (88% female, Mage = 14.9 ± 1.6 years, 95% White: Non-Hispanic, 1% White: Hispanic, 1% Bi-racial: Asian). Most study adolescents were diagnosed with AN (59%) while 41% were diagnosed with AAN. Participating parents were predominantly mothers (95%). Recruitment and retention rates were moderately high (76% and 71%, respectively). High acceptability and feasibility ratings were obtained from parents and interventionists with 100% reporting the EC intervention was "beneficial"-"very beneficial." The FBT + EC group demonstrated higher parental warmth scores at post-treatment compared to the control group (standardized effect size difference, d = 1.58), which was maintained at 3-month follow-up. Finally, at post-treatment, the FBT + EC group demonstrated higher rates of full remission from AN/AAN (40%) compared to FBT + support (27%), and were nine times more likely to be weight restored by 3-month follow-up. DISCUSSION: Augmenting FBT with emotion coaching for parents with high expressed emotion is acceptable, feasible, and demonstrates preliminary effectiveness. PUBLIC SIGNIFICANCE: Family based treatment for AN/AAN is the recommended treatment for youth but families with high criticism/low warmth are less likely to respond to this treatment. Adding a parent emotion coaching group (EC) where parents learn to talk to their adolescents about tough emotions is feasible and well-liked by families.

Integrated Behavioral Health Prevention for Infants in Pediatric Primary Care: A Mixed-Methods Pilot Study.

OBJECTIVE: Pediatric primary care is a promising setting in which to deliver preventive behavioral health services to young children and their families. Integrated behavioral health care models typically emphasize treatment rather than prevention. This pilot study examined the efficacy of an integrated behavioral health preventive (IBH-P) intervention delivered by psychologists and focused on supporting parenting in low-income mothers of infants as part of well-child visits in the first 6 months of life. METHODS: Using a mixed-methods approach that included a pilot randomized clinical trial and post-intervention qualitative interviews, 137 mothers were randomly assigned to receive IBH-P or usual care. Self-report measures of parenting, child behavior, and stress were obtained at pre- and/or post-intervention. Direct observation of mother-infant interactions was conducted at post-intervention. RESULTS: No differences between groups were found on maternal attunement, knowledge of child development, nurturing parenting, or infant behavior. A secondary analysis on a subsample with no prior exposure to IBH-P with older siblings found that mothers in IBH-P reported increased self-efficacy relative to controls. In the qualitative interviews, mothers stated that they valued IBH-P, learning about their baby, liked the integration in primary care, and felt respected and comfortable with their provider. CONCLUSIONS: Findings are discussed in terms of the next steps in refining IBH-P approaches to prevention in primary care.

Feasibility of Electronic Medication Monitoring Among Adolescents and Emerging Adults with Sickle Cell Disease.

Purpose: To examine the feasibility of using MEMS® bottles to assess adherence among adolescents and emerging adults with sickle cell disease. Patients and Methods: Eighteen non-Hispanic Black participants with HbSS (M = 17.8 years; 61% male) were given a MEMS® bottle to store hydroxyurea (n = 14) or deferasirox (n = 4). Results: One hundred percent initiated MEMS® use and 61% sustained use through the 18-week study; at follow-up, only 11% returned their bottle on time. Barriers to MEMS® use included medication changes and transition to adult care; facilitators included tip sheets and reminders. Conclusion: While MEMS® is acceptable to this population, ensuring sustained use and timely provision of bottles will require additional supports.

Achieving Independence and Mastery in School: A School-Based Executive Function Group Intervention for Autistic Middle Schoolers.

Executive functioning (EF) deficits, such as challenges with planning, organization, and materials management, negatively impact academic performance, particularly for middle-school students with autism spectrum disorder (ASD) without intellectual disability (ID). The aim was to assess the initial efficacy of the school-based version of the Achieving Independence and Mastery in School (AIMS) intervention in a pilot randomized clinical trial. 47 autistic middle-schoolers without ID attending nine different schools were randomized to participate in AIMS or to wait to receive AIMS the following semester (waitlist control = WLC). Youth, caregivers, and teachers rated academic EFs and academic functioning, and youth completed an objective EF measure, at baseline and outcome (post). Effect sizes were computed comparing baseline and post measures within each group. Individuals randomized to AIMS improved from baseline to post on academic EF outcome measures with small to moderate effect sizes, compared to WLC, who made some improvements but with generally smaller effect sizes. Analyses with academic functioning measures showed a similar pattern of results. These promising results suggest that AIMS delivered in the school by school-based personnel to small groups of students with ASD without ID can improve academic EF skills.

Patterns of substance use among adolescents in and out of foster care: An analysis of linked health and child welfare administrative data.

BACKGROUND: Young adults with a history of foster care have higher risk for substance use disorders. Social systems can deliver substance use prevention to youth; however, the timing of intervention delivery and how needs differ for youth in foster care are unclear. OBJECTIVE: To compare initiation and rates of substance use among adolescents in foster care to demographically similar adolescents never in foster care as identified by the healthcare system, and identify factors associated with increased substance use. PARTICIPANTS AND SETTING: Youth in foster care (n = 2787, ages 10-20, inclusive) and demographically matched youth never in foster care (n = 2787) were identified using linked child welfare and electronic health records from a single pediatric children's hospital and county over a five-year period (2012-2017). METHODS: All healthcare encounters were reviewed and coded for substance use by type (alcohol, tobacco, cannabis, other). Age of first reported or documented substance use was also captured. Demographic and child welfare information was extracted from administrative records. Survival and logistic regression models were estimated. RESULTS: In adjusted models, youth in foster care initiated substance use at earlier ages (HR = 2.50, p < .01) and had higher odds of engaging in use (AOR = 1.54; p < .01) than youth never in care. By age 12, substance use initiation was more likely while youth were in foster care than when they were not in foster care (HR = 1.42, p < .01). Placement stability and family care settings reduced odds of lifetime substance use. CONCLUSIONS: Foster care placement is associated with substance use. Screening may be important for prevention.

Behavior Problems in Low-Income Young Children Screened in Pediatric Primary Care.

Importance: Screening of behavior problems in young children in pediatric primary care is essential to timely intervention and optimizing trajectories for social-emotional development. Identifying differential behavior problem trajectories provides guidance for tailoring prevention and treatment. Objective: To identify trajectories of behavior problems in children 2 to 6 years of age screened in pediatric primary care. Design, Setting, and Participants: This retrospective cohort study identified trajectories of behavior problems and demographic and clinical correlates. Data were collected as part of routine care in 3 pediatric primary care offices and 3 school-based health centers in Ohio serving a primarily low-income population. In total, 15 218 children aged 2 to 6 years with well-child visits between July 13, 2016, and January 31, 2022, were included. Exposure: Caregivers completed the Strengths and Difficulties Questionnaire (SDQ) at annual well-child visits. Main Outcomes and Measures: Trajectory groups were identified using latent growth mixture modeling of SDQ total difficulties scores, and relative risk ratio (RRR) of various demographic (eg, race) and clinical (eg, depression in caregiver) variables were assessed by multinomial logistic regression analysis. Results: Of 15 281 children (51.3% males), 10 410 (68.1%) were African American or Black, 299 (2.0%) were Asian, 13 (0.1%) were American Indian or Alaska Native, 876 (5.7%) were multiracial, 26 (0.2%) were Native Hawaiian and Other Pacific Islander, 2829 (18.5%) were White, and 39 (0.02%) were categorized as other. In addition, 944 (6.2%) identified as Hispanic and 14 246 (93.2%) as non-Hispanic. Four behavior problem trajectory groups reflecting severity were identified: low-stable (LS; 10 096 [66.1%]), moderate-decreasing (MD; 16.6%), low-increasing (LI; 13.1%), and high-increasing (HI; 4.3%). Relative to the LS group, patients in each elevated group were more likely to be male (HI RRR, 1.87 [95% CI, 1.55-2.26]; MD RRR, 1.55 [95% CI, 1.41-1.71]; and LI RRR, 1.94 [95% CI, 1.70-2.21]), White (HI RRR, 2.27 [95% CI, 1.83-2.81]; MD RRR, 1.28 [95% CI, 1.13-1.45]; and LI RRR, 1.54, [95% CI, 1.32-1.81]), publicly insured (HI RRR, 0.49 [95% CI, 0.28-0.84]; MD RRR, 0.56 [95% CI, 0.43-0.73]; and LI RRR, 0.50 [95% CI, 0.35-0.73]), have a social need (HI RRR, 3.07 [95% CI, 2.53-3.73]; MD RRR, 2.02 [95% CI, 1.82-2.25]; and LI RRR, 2.12 [95% CI, 1.84-2.44]), and have a caregiver with depression (HI RRR, 1.66 [95% CI, 1.38-2.00]; MD RRR, 1.44 [95% CI, 1.31-1.58]; and LI RRR, 1.39 [95% CI, 1.23-1.58]). Relative to the LI group, patients in the MD group were less likely to be male (RRR, 0.80; 95% CI, 0.68-0.93). Conclusions: The substantial portion of young children with increased behavior problems observed in this cohort study underscores the need for screening in pediatric primary care. Caregivers with depression and family social needs warrant prioritization in early prevention and treatment to alter elevated trajectories.

The Barriers Assessment Tool-A Patient-Centered Measure of Adherence Barriers in Pediatric Kidney Transplantation.

OBJECTIVE: Assessing barriers to adherence provides helpful information to clinicians. The objective of this study was to describe the clinical utility of the Barriers Assessment Tool (BAT) using clinical data for a large, midwestern U.S. pediatric kidney transplant program. METHODS: Focus group and clinical data were obtained during post-transplant medical visits. Qualitative and quantitative assessment methods were utilized to describe patient and caregiver feedback on the BAT, clinical utility, concordance between reporters, and the effect of interventions on subsequent assessment and electronically measured adherence. RESULTS: Patients were willing to discuss adherence issues with their care team. There was substantial agreement between patients and caregivers at two timepoints. If a barrier was not addressed, 89.6% (43/48) of patients and 85.9% (67/78) of caregivers reported the same BAT scores from the first to second assessment. When barriers were addressed with a clinic-based intervention, 82% of caregivers reported no adherence barriers. No significant change was found for patient-reported barriers. CONCLUSIONS: Standardized assessment of barriers to medication adherence provides actionable information to clinicians. Standardized assessment of adherence barriers may give clinicians opportunities to help patients and caregivers overcome these barriers which can decrease risk of rejection.

A randomized clinical trial to support adherence regimens in children with epilepsy: Examining potential mechanisms of change.

OBJECTIVE: A family-tailored education and problem-solving intervention, Supporting Treatment Adherence Regimens (STAR), was developed to address the adherence challenges common in youth with epilepsy and their families. Randomized clinical trial (RCT) results indicated a 21% adherence improvement in the STAR group compared with an education-only (EO) group 12-months post-intervention. The current study examined group differences (STAR vs. EO) in epilepsy-specific knowledge, barriers to medication adherence, problem-solving skills, caregiver emotional distress, and family functioning over time and whether these factors mediated group differences in adherence at 12-months post-intervention. METHODS: Two-hundred children (ages 2-12) with epilepsy and their caregivers were included as RCT participants. Children with new-onset epilepsy and adherence <95% were randomized to receive either the STAR (n = 27) or EO (n = 29) intervention. Caregivers completed questionnaires assessing outcomes of interest at baseline, midpoint of the intervention, post-intervention, and 3-, 6-, and 12-month follow-ups. Regression-based analyses of covariance and longitudinal mixed effect linear models were conducted. RESULTS: Results generally revealed no significant group differences across outcomes of interest at post-intervention or over time. However, one significant model did emerge for social problem-solving skills (b = -1.74, p = 0.04), such that these scores were initially higher in the STAR group compared to the EO group, then decreased slightly in the STAR group over time while remaining stable in the EO group. None of these factors mediated group differences in adherence at 12-months post-intervention. CONCLUSION: Future research should examine other potential mechanisms of treatment change after adherence interventions, such as STAR. Nonsignificant findings can inform the development of future study designs and intervention efforts.

Augmenting family based treatment with emotion coaching for adolescents with anorexia nervosa and atypical anorexia nervosa: Trial design and methodological report.

This article characterizes the design, recruitment, methodology, participant characteristics, and preliminary feasibility and acceptability of the Families Ending Eating Disorders (FEED) open pilot study. FEED augments family-based treatment (FBT) for adolescents with anorexia nervosa (AN) and atypical anorexia nervosa (AAN) with an emotion coaching (EC) group for parents (i.e., FBT + EC). We targeted families high in critical comments and low warmth (assessed by the Five-Minute Speech Sample), known predictors of poor response in FBT. Eligible participants included adolescents initiating outpatient FBT, diagnosed with AN/AAN, ages 12-17, with a parent high in critical comments/low in warmth. The first phase of the study was an open pilot which demonstrated feasibility and acceptability of FBT + EC. Thus, we proceeded with the small randomized controlled trial (RCT). Eligible families were randomized to either 10 weeks of FBT + EC parent group treatment or the 10- week parent support group (control condition). The primary outcomes were parent critical comments and parental warmth, while our exploratory outcome was adolescent weight restoration. Novel aspects of the trial design (e.g., specifically targeting typical treatment non-responders), as well as recruitment and retention challenges in the context of the COVID-19 pandemic are discussed.

Predictors of objective treatment adherence in adolescents with epilepsy: The important role of motivation.

OBJECTIVE: Adolescents with epilepsy are at heightened risk for suboptimal anti-seizure medication (ASM) adherence; however, there is a paucity of adherence interventions for this age group. The current study aimed to identify a comprehensive and novel set of predictors of objective, electronically-monitored ASM adherence in adolescents with epilepsy. METHODS: Participants included 104 adolescents (13-17 years old; M = 15.36 ± 1.40), diagnosed with epilepsy and their caregivers. Cross-sectional data were collected from adolescents, caregivers, healthcare providers, and medical chart reviews, including demographics (i.e., age, race/ethnicity, sex, insurance status), the COVID-19 pandemic (i.e., participation before versus during), seizure characteristics (i.e., presence and severity), ASM side effects (Pediatric Epilepsy Side Effects Questionnaire), adherence motivation (1-item 6-point Likert scale item), and adherence barriers (Pediatric Epilepsy Medication Self-Management Questionnaire). Electronically-monitored adherence data was collected via the AdhereTechTM pill bottle or the Vaica SimpleMedTM pillbox over 30 days. RESULTS: Adolescents demonstrated suboptimal adherence at 78 ± 31.6%, despite high ASM adherence motivation (M = 4.43 ± .94) and minimal adherence barriers (M = 35.64 ± 3.78). Hierarchical multiple regression, which included non-modifiable sociodemographic and medical variables (Block 1) and behaviorally modifiable psychosocial variables (Block 2) was significant, F(12,87) = 3.69, p < .001. Specifically, having private insurance (versus Medicaid or public insurance; t = -2.11, p = .038) and higher adherence motivation (t = 2.91, p = .005) predicted higher objective ASM adherence. CONCLUSION: Routine assessment of adherence predictors is vital for the promotion of adherence among adolescents with epilepsy. Adolescent adherence motivation may be an important element of multi-component interventions focused on improving ASM adherence in adolescents with epilepsy.

Pilot randomized controlled clinical trial of an adherence social norms intervention for adolescents with epilepsy.

OBJECTIVE: Non-adherence to anti-seizure medications (ASMs) is common for adolescents with epilepsy, with potentially devastating consequences. Existing adherence interventions in epilepsy do not meet the unique challenges faced by adolescents. Leveraging social norms capitalizes on the increased importance of peer influence while simultaneously targeting the low motivation levels of many adolescents. The current study examined the feasibility, acceptability, and satisfaction of a social norms adherence intervention in adolescents with epilepsy. METHODS: A pilot RCT of a mHealth social norms intervention was conducted with adolescents with epilepsy who demonstrated non-adherence (≤95% adherence) during baseline. Adolescents were randomized to either (1) mHealth social norms (reminders, individualized and social norms adherence feedback) or (2) control (reminders and individualized adherence feedback). Primary outcomes included feasibility, acceptability, and satisfaction. Exploratory outcomes included electronically monitored adherence, seizure severity, and health-related quality of life (HRQOL). RESULTS: One hundred four adolescents were recruited (53% female; Mage = 15.4 ± 1.4 years; 81% White: Non-Hispanic; 5% Black, 10% Bi/Multiracial; 2% White: Hispanic; 1% Other: Hispanic; 1% Bi/Multiracial-Hispanic). Forty-five percent screen-failed due to high adherence, 16% withdrew, and 38% were randomized to treatment (n = 19) or control (n = 21). Recruitment (75%), retention (78%), and treatment satisfaction were moderately high. Engagement with the intervention was moderate, with 64% of participants engaging with intervention notifications. Exploratory analyses revealed that after controlling for COVID-19 impact, the social norms intervention group maintained higher adherence over time compared to the control group. Small to moderate effect sizes were noted for seizure severity and HRQOL between groups. CONCLUSION: This pilot intervention appeared feasible and acceptable. Increases in adherence in the treatment versus control group were modest, but a future larger more adequately powered study is needed to detect effects. Notably, it appeared the COVID pandemic influenced adherence behaviors during our trial.

Barriers to medication adherence among adolescents and young adults with cancer.

BACKGROUND: Adherence promotion is a critical component of adolescent and young adult (AYA) cancer care, but predictors of nonadherence that could be targeted in intervention efforts remain largely unknown. The purpose of this multi-site longitudinal observational study was to examine the relationship between barriers and medication adherence among AYAs with cancer. PROCEDURE: Sixty-five AYAs (ages 15-24 years; mean age = 18.97 years, SD = 2.51; Mmean time since diagnosis = 1.42 years, SD = 1.95) with newly diagnosed or relapsed cancer completed self-report measures of barriers and adherence at quarterly study visits and used an electronic adherence monitoring device for 12 months. Longitudinal mixed effects models were used to examine our primary hypothesis that greater barriers are related to lower adherence over time. Descriptive statistics were used to explore our secondary aim of describing the frequency and patterns of barriers endorsed by AYAs with cancer. RESULTS: After controlling for covariates (time, medication type, race, ethnicity, diagnosis, time since diagnosis), a greater number of barriers was associated with lower electronically monitored (ß = -5.99, p = .005) and self-reported (ß = -1.92, p < .001) adherence. The specific barriers endorsed by AYAs differed across participants, and the majority of AYAs endorsed an entirely different pattern of barriers than any other AYA in the study. CONCLUSION: Barriers are associated with nonadherence and may be a promising target for intervention. Individual variability across barriers, however, suggests that tailoring may be necessary, and a promising next step is to explore personalized approaches to adherence promotion.

Development and evaluation of the patient-reported outcomes measurement information system (PROMIS) pediatric pain quality item bank and short form.

ABSTRACT: Pain is a common problem among children, particularly those with pediatric chronic diseases. Multifaceted assessment of pain can improve communication about pain and help clinicians characterize, differentiate, and treat a patient's unique experience of pain. Pain quality is an important domain of pain, describing the subjective sensory experiences associated with pain as well as the affective experiences of pain. The aim of the current study was to quantitatively evaluate the measurement properties of the 59 Patient-Reported Outcomes Measurement Information System pediatric pain quality candidate items developed as part of the National Institutes of Health's Patient-Reported Outcomes Measurement Information System initiative with input from children and adolescents with chronic pain. Participants included N = 448 pediatric patients between 8 and 18 years of age with chronic health conditions with a prominent component of chronic or recurrent pain, including juvenile fibromyalgia, juvenile idiopathic arthritis, and sickle cell disease. A confirmatory factor analysis revealed a unidimensional model fit the data best, with 56 of the 59 items demonstrating good psychometric properties for inclusion in the final measure. In addition, a consensus-building method was used to establish 2 versions of a short form measure-one with 8 items focused primarily on the sensory pain qualities and one with 8 items focused on affective pain qualities. The final measure shows good reliability and validity, and is recommended for use in research and clinical care with pediatric populations.

A Pilot Randomized Trial of an Obesity Prevention Program for High-Risk Infants in Primary Care.

OBJECTIVE: Rapid infant weight gain is associated with later obesity. Novel interventions to prevent rapid infant weight gain that are accessible to infants and families are needed, especially for those at the highest risk. Our aims were to examine: (a) feasibility and acceptability of a responsive parenting intervention delivered via Integrated Behavioral Health (IBH) in pediatric primary care and (b) preliminary effects on infant weight gain from birth to 6 (post-treatment) and 9 (follow-up) months. METHODS: A parallel design, proof-of-concept randomized control trial was conducted with 65 mother-infant dyads (32 randomized to intervention, 33 randomized an IBH attention control focused on promoting healthy mental health), in which the majority identify as Black (80%) and low income (91% receiving Medicaid). Participants and assessors were masked to treatment condition. Outcomes included feasibility (enrollment), acceptability (retention and adherence), and conditional weight gain (CWG), an indicator of rapid weight gain. RESULTS: The intervention was feasible (90% of eligible families enrolled) and acceptable (89% of families retained), with 81% receiving ≥3 of 4 treatment sessions. A medium effect was found on CWG (d = -0.54 post-treatment, d = -0.57 follow-up), with the infants in the treatment group showing significantly lower CWG (mean = -0.27, 95% CI, -0.63, 0.09) compared to the control group (mean = 0.29, 95% CI, -0.17, 0.76) at 9 months (p = .04). CONCLUSIONS: This study demonstrates the feasibility of implementing a responsive parenting obesity prevention intervention within primary care. Delivery in pediatric primary care is advantageous for implementation and reaching at-risk populations. The preliminary effects on CWG are promising and support testing in a larger trial.

Careful: An administrative child welfare and electronic health records linked dataset.

Between 2012 and 2017, N = 2814 youth between the ages of 4 and 20 were in child protective services (CPS) custody in Hamilton County, Ohio, and placed in out-of-home care. Child welfare administrative records were extracted and linked to electronic health records for all encounters at Cincinnati Children's Hospital Medical Center, with n = 2787 (99.1%) of records successfully linked prior to de-identifying the data for research purposes. Child welfare administrative data fields in the dataset include demographics, dates of entry into and exit from protective custody and out-of-home care, reasons for entry into custody, dates of placement changes, reasons for placement changes, and types of placement (e.g., foster home, kinship home, group home, residential treatment, independent living). Electronic health records (EHR) data fields include demographics, all inpatient and outpatient encounters with medications, diagnoses, screening results, laboratory test results, flowsheet data, and problem list entries. Data have been coded to capture broader categories of health needs and encounter details, medications, and other health concerns. Due to the high representation of children in CPS custody and out-of-home care who are also represented in the EHR data, this dataset provides a comprehensive view of the medical needs and health concerns for school-aged children in CPS custody in an entire county. As a result, these data can be useful for understanding the emergence of global and specific health concerns, frequency of healthcare use, and placement stability for all youth in CPS custody in this community, accounting for variation due to other health and child welfare factors. These data are likely generalizable to other mid-sized urban communities where academic medical centers provide healthcare for children in CPS custody. De-identified data may be made available to other researchers with approved data transfer agreements between academic institutions in place.

Key predictors of the need for a family-focused pediatric epilepsy adherence intervention.

OBJECTIVE: Nonadherence to antiseizure drugs is a significant problem in pediatric epilepsy and is linked to increased morbidity and mortality, clinically unnecessary medication changes, and increased health care costs. Family interventions can improve adherence. However, it is challenging to determine which families will struggle with nonadherence and require intervention. This study aims to identify specific parent, family, child, and medical factors that predict which families most need family-based adherence interventions. METHODS: Families enrolled in a randomized clinical trial of a family-based adherence intervention completed measures assessing parent, family, child, and medical factors. Families also used an electronic adherence monitor. Adherence of ≥95% was considered high adherence (not requiring intervention), and <95% was considered suboptimal adherence (requiring intervention). We conducted a stepwise logistic regression analysis to assess demographic, medical, child, family, and parent predictors of membership to the suboptimal adherence group. RESULTS: Of the 200 families of children with new onset epilepsy who enrolled, 177 families completed the study. Of these families, 121 (68%) were in the high adherence group and 56 (32%) were in the suboptimal adherence group. Families with lower socioeconomic status (SES), children of color, lower general family functioning, and more parent distress were more likely to be in the suboptimal adherence group. SIGNIFICANCE: We identified that parent and family factors, as well as sociodemographic characteristics, predicted membership in the suboptimal adherence group. It is critical to find creative and practical solutions for assessing and intervening upon key adherence predictors. These may include streamlined screening for parental distress and family functioning, as well as recognition that families of lower SES and communities of color may be at heightened risk for suboptimal adherence.

Development and Preliminary Validation of a Multidimensional Psychosocial Assessment Strategy for Young Adults With Cancer.

OBJECTIVE: Regular psychosocial assessment is a best-practice guideline for young adult oncology care, but multipurpose, multidimensional, developmentally appropriate patient-reported outcome measurement strategies for young adults with cancer are lacking. This study reported on the development and preliminary validation of the Young Adult Psychosocial Assessment Strategy (YA-PAS), a tool designed to meet this clinical need. METHODS: The YA-PAS was developed based on the literature and clinician feedback. 20 young adults with cancer participated in cognitive interviews to provide feedback on complexity, readability, and applicability to inform measure refinement. Following refinements, 100 young adults with a history of cancer participated in an observational study including a preliminary evaluation of YA-PAS factor structure, internal consistency, test-retest reliability, construct and criterion validity, feasibility, and acceptability. RESULTS: Cognitive interviews and psychometric evaluation informed modifications and resulted in a measure with 9 domains (anxiety, depression, cognitive functioning, post-traumatic stress, family stressors, support, social isolation, self-efficacy for symptom management, and self-efficacy for medication management) and nonscoring items assessing substance use, life stressors, resources, educational/vocational status, and relationship status. 8 of 9 domains demonstrated acceptable internal consistency (Cronbach's α ≥ 0.70), substantial (r = 0.61-0.80) or almost perfect (r > 0.80) test-retest reliability, and evidence of domain and cut-point validity. 89% of participants were able to complete the YA-PAS within 20 min and 87% were satisfied with the measure. CONCLUSIONS: The YA-PAS demonstrated promising psychometric properties, feasibility, and acceptability. Clinical implications and research recommendations are discussed.

Patterns of healthcare utilization with placement changes for youth in foster care.

BACKGROUND: Children in foster care experience poor health and high healthcare use. Child welfare agencies frequently require healthcare visits when children enter foster care; subsequent placement changes also disrupt healthcare. Studies of healthcare use have not accounted for placement changes. OBJECTIVE: To understand patterns of healthcare use throughout the time a child enters foster care and with placement changes, accounting for mandated visits when children enter foster care or experience a placement change. PARTICIPANTS AND SETTING: Children 4 and older in foster care between 2012 and 2017 (N = 2787) with linked child welfare administrative data from one county child welfare agency and one Midwest pediatric healthcare system. METHODS: Negative binomial models predicted healthcare days per month that were planned (e.g., scheduled primary/specialty care), unplanned (e.g., emergency care), or missed. RESULTS: Planned healthcare days increased as a function of placement changes (Incident Rate Ratio [IRR] =1.69, p < .05) and decreased with placement stability (IRR = 0.92, p < .01). Mandated visits that occurred later in a placement were associated with fewer planned (IRR = 0.81, p < .01) and unplanned (IRR = 0.82, p < .01) healthcare days during that placement. CONCLUSIONS: Patterns of planned healthcare over the time children are in one placement and move between placements suggest more can be done to ensure youth remain connected to primary and specialty care throughout placements and placement transitions, s that children are seen as clinically appropriate rather than a function of placement disruption. Findings regarding the timing of mandated visits suggest that delays in mandated care may also reflect lower healthcare use overall.

Racial Disparities in Medication Adherence Barriers: Pediatric Epilepsy as an Exemplar.

OBJECTIVE: To evaluate how racial disparities in medication adherence barriers relate to key clinical outcomes (i.e., seizure control and adherence) in pediatric epilepsy and to identify the most critical barriers in determining health outcomes in Black youth and White youth. METHODS: This observational study included a sample of youth aged 2-17 years with epilepsy obtained by combining data from four different studies. A total of 226 caregivers and 43 adolescents reported on adherence barriers. An electronic monitor was used to measure adherence to the primary antiepileptic drug. Racial disparities in individual barriers were examined. The relative importance of different types of barriers in determining clinical outcomes was evaluated in both Black and White youth. RESULTS: Adherence barriers, including running out of medications, access to pharmacies, competing demands, and difficulty swallowing, disproportionally affected Black children with epilepsy compared to White children. System- and community-level barriers emerged as the most important in determining seizure outcomes among Black youth. Both system- and individual-level barriers, on the other hand, were important for adherence outcomes. CONCLUSIONS: System- and community-level barriers, as opposed to individual-level barriers, are more highly endorsed by Black families compared to White families. These barriers are also the most critical in driving seizure outcomes among Black youth. There is a critical need to shift from a primary focus on individual-level barriers to an approach that deliberately targets larger systemic barriers to reduce the existing adherence and health disparities that affect Black children with pediatric conditions.