Key predictors of epilepsy-specific health-related quality of life (HRQOL) in youth with epilepsy.

PURPOSE: Epilepsy-specific health-related quality of life (HRQOL) is an important outcome in youth with epilepsy (YWE). The PedsQL™ Epilepsy Module is the only caregiver-proxy and youth self-report epilepsy-specific HRQOL measure that can be used with youth 2-25 years. Multiple factors affect HRQOL, including epilepsy-specific characteristics, comorbid mental and behavioral health concerns, as well as sociodemographic factors. However, we have not yet examined the cumulative impact of these factors on epilepsy-specific HRQOL in YWE using the PedsQL™ Epilepsy module. METHOD: Youth with epilepsy (n = 281) and their caregivers completed questionnaires focused on sociodemographic factors (e.g., youth biological sex and age), mood/anxiety and behavior symptoms (i.e., Behavioral Assessment Scale for Children - Second Edition; BASC-2, Parent Rating Scale), epilepsy characteristics [e.g., seizure frequency, number of anti-seizure medications (ASMs), ASM side effects, and years since diagnosis], and the PedsQL™ Epilepsy module (subscales: Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior). RESULTS: Hierarchical linear regressions were conducted to examine caregiver-proxy and youth self-reported factors that affect epilepsy-specific HRQOL. Results indicate the strongest key shared predictors of HRQOL in YWE, for both youth and caregiver informants, were mental and behavioral health symptoms. For instance, caregiver-proxy report of YWE HRQOL indicated BASC-2 Externalizing (p < 0.05), Behavioral Symptoms (p < 0.01), and Adaptive Skills (p < 0.001) explained 58 % of the variance in youth Cognitive Functioning HRQOL, while youth self-report of HRQOL indicated that BASC-2 Externalizing (p < 0.01), Behavioral Symptoms (p < 0.05), and Adaptive Skills (p < 0.001) contributed only 36 % of the variance in Cognitive Functioning HRQOL above and beyond the variance explained by sociodemographic and epilepsy-specific characteristics. Similar results were noted for Executive Functioning HRQOL domain, wherein caregiver-proxy report of YWE HRQOL indicated BASC-2 Internalizing (p < 0.01), Behavioral Symptoms (p < 0.001) and Adaptive Skills (p < 0.001) explained 65 % of variance in Executive Functioning, whereas youth self-report of Executive Functioning HRQOL indicated that caregiver-proxy BASC-2 Internalizing (p < 0.001) and Behavioral Symptoms (p < 0.01) explained 34 % of the variance in Executive Functioning HRQOL, above and beyond the variance explained by sociodemographic and epilepsy-specific characteristics. Unique mental and behavioral health predictors of YWE HRQOL were also found for both caregiver-proxy and youth self-report. CONCLUSIONS: Given the integral role of mental and behavioral health symptoms in epilepsy-specific HRQOL, it is critical to address mental and behavioral health symptoms preventatively and proactively to provide YWE with the most optimal health plan, including good seizure control, minimal ASM side effects, and the best possible HRQOL.

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.

Demystifying a family-based epilepsy adherence problem-solving intervention: Exploring adherence barriers and solutions.

Objective: Barriers to medication adherence are common in pediatric epilepsy and associated with nonadherence, suboptimal seizure outcomes, and quality of life. A manualized, family-tailored education and problem-solving adherence intervention to address adherence barriers was tested in a randomized controlled trial in young children (2-12 years) with epilepsy. Study aims were to identify the adherence barriers and solutions chosen by families during intervention. Methods: Participants with demonstrated non-adherence were randomized to either education attention control or treatment. In this exploratory, secondary analysis, treatment group data were examined, including adherence barriers and solutions discussed during face-to-face problem-solving sessions and telephone follow-ups. Treatment data were independently coded utilizing codebook thematic analysis. Results: Twenty-seven children were randomized to treatment (M=7.5±2.9; 59.1% female). Across sessions, coding revealed 10 adherence barriers: Overall Forgetting (38-57%), Routine Change Routine (14-24%), Competing Activities (5-19%), Opposition (0-9%), Transition of Responsibility (0-5%), Running Out of Medication (0-10%), Forgetting During Travel (0-10%), Medication Not a Priority (0-5%), Medication Taste (0-5%), and Pill Swallowing (0-5%). Eight solution types were chosen and implemented by families: Environmental Cuing (29-50%), Multi-Pronged solutions (0-24%), Positive Reinforcement (14-23%), Back-up Doses (0-14%), Refill Tracking (0-10%), Caregiver Modeling of Adherence Behavior (0-5%), Pill Swallowing Intervention (0-5%), and Other (0-5%). Conclusions: Results highlight key adherence barriers identified by families of children with epilepsy and solutions implemented to address them. These data provide guidance to healthcare teams on how to successfully address adherence barriers in clinical settings.Clinical trials #NCT01851057.

Behavioral health screening in pediatric epilepsy: Which measures commonly used in the United States are 'good enough'?

PURPOSE: To improve evidence-based implementation of behavioral health screening measures in pediatric epilepsy care, guidance is needed in the selection and interpretation of evidence-based screening measures. Therefore, the goals of this project were to (1) evaluate the clinical utility and psychometric properties of screening instruments frequently used in the United States (US) for anxiety, depression, and behavior problems in youth with epilepsy (YWE), and (2) provide guidance around selection and interpretation of these behavioral health screening measures. METHOD: The critique was conducted in three phases: (1) identification of articles based on search criteria; (2) full review of articles for eligibility assessment; (3) evaluation of screening measures and organization into Tiers. Nine behavioral health measures frequently used to screen for anxiety, depression, and disruptive behaviors in the US were selected for evaluation. PubMed, CINAHL, Medline, and APA databases were searched using the following search terms: [target area] + [screening measure] + epilepsy + children [youth], [adolescents]. Inclusion/exclusion criteria for articles were as follows: (1) focused on YWE, (2) written in English, and (3) conducted in the US. Once articles were selected, Hunsley and Mash's criteria were used to evaluate and categorize the screening measures' psychometric properties, which have clear relevance to clinical practice. Measures were also classified into three tiers by the level of validation according to established evidence-based criteria. RESULTS: Forty-one unique papers were identified through the literature search and assessed as eligible. Evaluation of screening measures revealed only two psychometrically sound measures that met criteria for Tier 1, the NDDI-E-Y and the Pediatric NeuroQoL-Depression, both depression screening measures. Several additional depression screening measures met criteria for Tier 2 (CDI-2, BASC-2-Depression Scale, and CBCL Withdrawn/Depressed Scale). Anxiety screening measures have not been validated in pediatric epilepsy and thus only met the criteria for Tier 2 (BASC-2 Anxiety Scale, CBCL DSM-IV Oriented Anxiety Problems Scale, MASC). Similarly for disruptive behaviors, two measures met Tier 2 criteria (BASC-2 Externalizing Problems Index, CBCL Externalizing Problems Index). CONCLUSION: Strides have been made in the validation of behavioral health screening measures for YWE; however, continued research in this area is necessary to validate existing psychometrically sound measures and to develop and evaluate epilepsy-specific measures in the pediatric epilepsy population.

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.

Learning experience design of an mHealth intervention for parents of children with epilepsy.

PURPOSE: The purpose of this paper is to describe the iterative design, development, and evaluation of a novel mHealth learning environment for parents of children with epilepsy. The mHealth learning environment is a component of a broader behavioral intervention called eACT (Epilepsy Adherence in Children and Technology), which seeks to improve antiepileptic drug adherence in children with epilepsy. The eACT mHealth learning environment integrates theoretical principles from the learning sciences with user-centered design methods and advanced learning technologies to provide an efficient and appealing learning experience that is specifically tailored to adult learners. METHODS: The eACT mHealth learning environment was developed by a multidisciplinary team of experts across three major phases including: 1) preparation, 2) iterative design, and 3) iterative development. The preparation phase included developing user personas and conducting focus groups, which identified user needs and use cases for the product. The iterative learning experience design process made use of rapid prototypes in which the product design was improved between versions, resulting in a final design proof. Usability and user experience methods were deployed to evaluate the system during the iterative development phase. RESULTS: Results from three phases of iterative design and development are presented through user personas, usability data, and qualitative analysis. Findings suggest the eACT mHealth learning environment is highly usable and relevant to the unique needs of adult caregivers of children with epilepsy. Findings also suggest that user experience was largely positive. CONCLUSIONS: This paper reveals key insights about how formative learning experience design processes can lead to highly relevant and usable interventions for adult learners.

Supporting treatment adherence regimens in children with epilepsy: A randomized clinical trial.

OBJECTIVE: This study was undertaken to examine the efficacy of a family-tailored education and problem-solving behavioral intervention, Supporting Treatment Adherence Regimens (STAR), in young children (2-12 years old) with new onset epilepsy compared to an attention control (i.e., education only [EO]) intervention. Participants randomized to the STAR intervention were hypothesized to demonstrate significantly improved adherence at postintervention and 3-, 6-, and 12-month follow-up visits compared to the EO intervention. Seizure and health-related quality of life (HRQOL) outcomes were also examined. METHODS: Two hundred children with new onset epilepsy and their caregivers were recruited during routine epilepsy clinic visits. Baseline questionnaires were completed, and electronic adherence monitors were provided. Participants with adherence less than 95% during the run-in period were randomized to either STAR or EO intervention. Active intervention was provided to both groups for 4 months. Questionnaires were completed at conclusion of the active intervention phase and three follow-up time points (3, 6, and 12 months). Group differences in adherence, seizure outcomes, and HRQOL were examined using regression-based analyses of covariance and longitudinal mixed effect linear or logistical models. RESULTS: Adherence at 12-month follow-up was significantly different between the STAR (mean = 82.34, SD = 21.29) and EO intervention groups (mean = 61.77, SD = 28.29), with the STAR group demonstrating 20.6% greater adherence (b = 19.11, p = .04, 95% confidence interval = 1.00-37.22, d = .83). No significant differences were found between groups in seizure and HRQOL outcomes. SIGNIFICANCE: A family-based behavioral adherence intervention demonstrated sustained adherence improvements 1 year following epilepsy diagnosis compared to an epilepsy-specific education intervention. STAR is an efficacious adherence intervention that can easily be implemented into routine epilepsy care.

The psychosocial impact of COVID-19 within the first six months of the pandemic on youth with epilepsy and their caregivers.

OBJECTIVES: We assessed the impact of COVID-19 on children with epilepsy and their families, focusing on epilepsy management, family routines, learning, and adherence to Centers for Disease Control and Prevention (CDC) pandemic guidelines (e.g., social distancing, mask wearing) within the first six months of the pandemic. Group differences in COVID-19 impact on families were also examined based on race and ethnicity, being medically and/or geographically underserved, and insurance status. METHODS: Participants (n = 131) included children with epilepsy and their families from two clinical trials. The Impact of COVID-19 on Pediatric Epilepsy Management (ICPEM) measure was developed and administered to caregivers online from April 2020 to September 2020 across four large pediatric hospitals. Administration of the ICPEM occurred both during routine study assessments and an additional acute time point to obtain information early in the pandemic (e.g., April and May 2020). Descriptive statistics and t-tests were used for analyses. RESULTS: Data indicate minor to moderate impact of COVID-19 on pediatric epilepsy management. Caregivers of children with epilepsy reported the most impact on education and social functioning. Adherence to CDC guidelines was reported to be high. Those having public insurance reported greater difficulties obtaining daily anti-seizure medications compared to those with private insurance. CONCLUSIONS: This study presents important initial data regarding the impact of COVID-19 epilepsy management and daily functioning in children with epilepsy and their families. While the acute impact of COVID-19 restrictions appear to be mild to moderate, it is unclear what the long-term impact of the pandemic will be on families of children with epilepsy.

Supporting Treatment Adherence Regimens in young children with epilepsy and their families: Trial design and baseline characteristics.

This article describes the methodology, recruitment, design, and baseline participant characteristics of the Supporting Treatment Adherence Regimens (STAR) trial. STAR is a randomized controlled clinical trial of an education and problem-solving adherence intervention for young children (2-12 years old) with newly diagnosed epilepsy and their families. Using an enrichment design, only participants who demonstrated non-adherence to anti-epileptic drugs within the baseline period were randomized to treatment or control arms. Randomized participants received 8 intervention sessions over a 4-month period and completed three follow-up visits (3, 6, and 12 months following intervention). Two-hundred participants were recruited for the study. The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life. Novel aspects of the trial design (e.g., enrichment, sequential randomization, daily adherence data use), as well as recruitment and retention challenges are discussed.

PedsQL™ Cognitive Functioning Scale in youth with epilepsy: Reliability and validity.

OBJECTIVE: The objective of the study was to report on the internal consistency reliability and discriminant, concurrent and construct validity of the Pediatric Quality of Life Inventory™ (PedsQL™) Cognitive Functioning Scale as a brief generic cognitive functioning measure in youth with epilepsy. METHODS: The 6-item PedsQL™ Cognitive Functioning Scale and 23-item PedsQL™ 4.0 Generic Core Scales were completed by 221 pediatric patients ages 5-18 years with epilepsy and 336 parents of patients ages 2-18 years in a national field test study for the PedsQL™ Epilepsy Module. Parents also completed the 86-item Behavior Rating Inventory of Executive Function (BRIEF), a widely validated measure of executive functioning. RESULTS: The PedsQL™ Cognitive Functioning Scale evidenced excellent reliability (patient self-report α = 0.88; parent proxy-report α = 0.96), distinguished between youth with epilepsy and an age, gender, and race/ethnicity-matched healthy sample supporting discriminant validity with large effect sizes (~20-30 point score differences, P < 0.001), and demonstrated concurrent and construct validity, respectively, through large effect size intercorrelations with the BRIEF (Behavioral Regulation Index, Metacognition Index, Global Executive Composite Summary Scores rs = 0.43-0.67, P < 0.001) and the PedsQL™ Generic Core Scales (Total Scale Scores rs = 0.67-0.74, P < 0.001). Minimal clinically important difference (MCID) scores ranged from 5.92 to 8.80. CONCLUSIONS: The PedsQL™ Cognitive Functioning Scale demonstrated excellent internal consistency reliability, discriminant, concurrent, and construct validity in youth with epilepsy and may be suitable as a brief generic patient-reported outcome (PRO) measure for clinical research, clinical trials, and routine clinical practice in pediatric epilepsy.

Current behavioral health and cognitive screening practices in pediatric epilepsy.

PURPOSE: Initiatives such as the Epilepsy Learning Healthcare System continue to advocate for standardized care and shared outcome data. Therefore, the current project aim was to gather information from epilepsy healthcare professionals, behavioral health professionals in particular, regarding their behavioral health and cognitive screening practices in pediatric patients with epilepsy. Information obtained will be used to assist in the development of new educational programs and platforms in the American Epilepsy Society (AES) and to inform the development of guidelines for behavioral healthcare of patients with pediatric epilepsy. SURVEY INFORMATION: Twenty-five AES members representing 25 unique epilepsy programs across the United States participated in the survey. Findings are described in terms of three focus areas: (1) Systems, (2) Assessment, and (3) Intervention. Over 80% of respondents surveyed reported that they do conduct formal screenings, most commonly to determine if further evaluation is indicated (81%), inform treatment decisions (57.1%), and for developmental surveillance (33.3%). Assessment methods were fairly evenly split between nonstandardized informal questions (50%) and evidence-based broadband measures, with the Behavior Assessment System for Children (BASC), 2nd or 3rd Editions (40%) most commonly used. If behavioral health concerns are identified, referrals are often made for psychotherapy (48% in-house; 80% community-based), psychiatry (68% in-house; 48% community-based), and cognitive testing (88% neuropsychological testing; 36% for psychoeducational testing). Thirty-two percent refer for psychotropic medication management. CONCLUSION: According to this survey, a number of epilepsy centers and clinics incorporate behavioral health screening; however, there is significant variability in assessments/measures used, who is administering them, and their purpose in the trajectory of treatment. These findings emphasize the need for standardization across centers in order to most effectively provide comprehensive care for youth with epilepsy.

Establishing clinical cutoffs for the PedsQL™ Epilepsy Module.

OBJECTIVE: The purpose of the present study was to establish clinical cutoffs for the PedsQL Epilepsy Module scales by dichotomizing scores into normative or impaired. We predicted that these cutoffs would be useful in identifying children at greater risk for impairments in health-related quality of life (HRQOL) including those who exhibit effects of ongoing seizures, antiepileptic drugs (AEDs), and polytherapy. METHODS: Two hundred and thirty-seven youth (2-18 years old) and their caregivers were recruited from five tertiary care hospitals across the United States. Caregivers and youth (5 years and older) completed the parent- or self-report versions of the PedsQL Epilepsy Module. Caregivers also completed measures of behavior and mood, AED side effects, and executive functioning in children. Clinical cutoffs were calculated in two ways: anchor-based (receiver operating characteristic (ROC) curve) and distribution-based (0.5 standard deviation (SD)). Medical characteristics were abstracted from the medical chart. t-Tests and chi-square tests were used to determine whether children's HRQOL classified as normative or impaired in epilepsy quality of life differed on seizure freedom, AED side effects, and polytherapy. RESULTS: The final clinical cutoffs were as follows for each PedsQL Epilepsy Module subscale (caregiver and child): Impact (Parent = 60.7; Child = 64.39), Cognitive (Parent = 38.11; Child = 50.97), Executive Functioning (Parent = 46.65; Child = 57.15), Sleep (Parent = 42.07; Child = 43.90), and Mood/Behavior (Parent = 54.14; Child = 53.30). Youth with more severe AED side effects, ongoing seizures, and/or on polytherapy were more likely to have impaired quality of life across domains. CONCLUSION: Clinical cutoffs extend this instrument's utility in surveilling common psychosocial comorbidities, tracking changes in functioning over time, and informing clinical decision-making in youth with epilepsy including recommendations for additional assessment and intervention by a range of health providers serving youth with epilepsy (YWE).

Vulnerabilities to antiepileptic drug (AED) side effects in youth with epilepsy.

OBJECTIVE: The objective of the study was to investigate the relationship between sociodemographic, seizure-related, behavioral health, and antiepileptic drug (AED) adverse effect variables. The aim of this study was to examine whether there were significant differences on AED adverse effects between youth with normative and subclinical/clinical depressive and/or anxiety symptoms. METHODS: As part of a larger multisite validation study, 231 youth age 5 to 18 years diagnosed with epilepsy and their caregivers were recruited to participate for the current study. Youth ages 8 and older and caregivers of all youth completed the Behavior Assessment System for Children-2 (BASC-2). Caregivers also completed the Pediatric Epilepsy Side Effects Questionnaire (PESQ) and a Background Questionnaire. Medical chart review provided information regarding epilepsy diagnosis and treatment. RESULTS: No differences were observed in the mean scores on AED adverse effects between the group with subclinical/clinical BASC-2 Depressive symptoms and those with average/low depressive symptoms. In contrast, the proportion of youth with subclinical/clinical versus average/low depressive symptoms via caregiver report was significantly different for the cognitive, behavioral, general neurological, and total scale of the PESQ. There was also a larger proportion of youth with self-reported subclinical/clinical depressive symptoms who experienced general neurological adverse effects compared with youth with average/low depressive symptoms who experienced general neurological adverse effects. Findings were consistent for anxiety symptoms. SIGNIFICANCE: Identifying potentially modifiable behavioral health symptoms that exacerbate the expression of AED adverse effects could provide alternative solutions for improved AED tolerability to achieve optimum treatment outcomes.

Quality of life improves with integrated behavioral health services in pediatric new-onset epilepsy.

The current study compared differences in health-related quality of life (HRQOL) between youth with new-onset epilepsy with and without elevated psychological symptoms at time of epilepsy diagnosis within an integrated behavioral health and epilepsy service. Patients received both behavioral health and epilepsy care during clinic visits. A retrospective chart review was conducted between July 2011 and December 2015. Caregivers completed the Behavior Assessment System for Children-2: Parent Rating Scale (BASC-2: PRS) to assess psychological symptoms at the diagnostic visit, along with completing the Pediatric Quality of Life Inventory (PedsQL™ 4.0) at the diagnostic visit and each subsequent epilepsy clinic visit during the first year of treatment. Latent growth curve modeling was used to identify HRQOL changes over the first year of treatment. Health-related quality of life was significantly lower for youth with elevated psychological symptoms at diagnosis and over the first year of treatment compared with those without psychological symptoms. For those with elevated internalizing, inattention, withdrawal, and atypical symptoms at diagnosis, greater HRQOL improvements were detected over the first year of treatment compared with those without elevated psychological symptoms at the diagnostic visit. Within integrated behavioral health and epilepsy routine care, targeted psychological interventions can improve HRQOL over the first year of treatment, particularly for those with premorbid psychological symptoms.

Antiepileptic drug behavioral side effects and baseline hyperactivity in children and adolescents with new onset epilepsy.

OBJECTIVE: To examine baseline psychological functioning and antiepileptic drug (AED) behavioral side effects in new onset epilepsy and determine, by age, whether baseline psychological functioning predicts AED behavioral side effects 1 month following AED initiation. METHODS: A retrospective chart review was conducted between July 2011 and December 2014 that included youths with new onset epilepsy. As part of routine interdisciplinary care, caregivers completed the Behavior Assessment System for Children, 2nd Edition: Parent Rating Scale to report on baseline psychological functioning at the diagnostic visit and the Pediatric Epilepsy Side Effects Questionnaire to identify AED behavioral side effects at the 1-month follow-up clinic visit following AED initiation. Children (age = 2-11 years) and adolescents (age = 12-18 years) were examined separately. RESULTS: A total of 380 youths with new onset epilepsy (Mage  = 8.9 ± 4.3 years; 83.4% Caucasian; 34.8% focal epilepsy, 41.1% generalized epilepsy, 23.7% unclassified epilepsy) were included. Seventy percent of youths had at-risk or clinically elevated baseline psychological symptoms. Children had significantly greater AED behavioral side effects (M = 25.08 ± 26.36) compared to adolescents (M = 12.36 ± 17.73), regardless of AED. Valproic acid demonstrated significantly greater behavioral side effects compared to all other AEDs, with the exception of levetiracetam. Higher hyperactivity/impulsivity at baseline significantly predicted higher AED behavioral side effects 1 month after AED initiation in both age groups. SIGNIFICANCE: Younger children seem to be more prone to experience behavioral side effects, and these are likely to be higher if youths with epilepsy have baseline hyperactivity/impulsivity. Baseline psychological screening, specifically hyperactivity, can be used as a precision medicine tool for AED selection.

Validation of the PedsQL Epilepsy Module: A pediatric epilepsy-specific health-related quality of life measure.

OBJECTIVE: To validate a brief and reliable epilepsy-specific, health-related quality of life (HRQOL) measure in children with various seizure types, treatments, and demographic characteristics. METHODS: This national validation study was conducted across five epilepsy centers in the United States. Youth 5-18 years and caregivers of youth 2-18 years diagnosed with epilepsy completed the PedsQL Epilepsy Module and additional questionnaires to establish reliability and validity of the epilepsy-specific HRQOL instrument. Demographic and medical data were collected through chart reviews. Factor analysis was conducted, and internal consistency (Cronbach's alphas), test-retest reliability, and construct validity were assessed. RESULTS: Questionnaires were analyzed from 430 children with epilepsy (Mage = 9.9 years; range 2-18 years; 46% female; 62% white: non-Hispanic; 76% monotherapy, 54% active seizures) and their caregivers. The final PedsQL Epilepsy Module is a 29-item measure with five subscales (i.e., Impact, Cognitive, Sleep, Executive Functioning, and Mood/Behavior) with parallel child and caregiver reports. Internal consistency coefficients ranged from 0.70-0.94. Construct validity and convergence was demonstrated in several ways, including strong relationships with seizure outcomes, antiepileptic drug (AED) side effects, and well-established measures of executive, cognitive, and emotional/behavioral functioning. SIGNIFICANCE: The PedsQL Epilepsy Module is a reliable measure of HRQOL with strong evidence of its validity across the epilepsy spectrum in both clinical and research settings.

Development of the PedsQL™ Epilepsy Module: Focus group and cognitive interviews.

UNLABELLED: Youth with epilepsy have impaired health-related quality of life (HRQOL). Existing epilepsy-specific HRQOL measures are limited by not having parallel self- and parent-proxy versions, having a restricted age range, not being inclusive of children with developmental disabilities, or being too lengthy for use in a clinical setting. Generic HRQOL measures do not adequately capture the idiosyncrasies of epilepsy. The purpose of the present study was to develop items and content validity for the PedsQL™ Epilepsy Module. METHODS: An iterative qualitative process of conducting focus group interviews with families of children with epilepsy, obtaining expert input, and conducting cognitive interviews and debriefing was utilized to develop empirically derived content for the instrument. Eleven health providers with expertise in pediatric epilepsy from across the country provided feedback on the conceptual model and content, including epileptologists, nurse practitioners, social workers, and psychologists. Ten pediatric patients (age 4-16years) with a diagnosis of epilepsy and 11 parents participated in focus groups. Thirteen pediatric patients (age 5-17years) and 17 parents participated in cognitive interviews. RESULTS: Focus groups, expert input, and cognitive debriefing resulted in 6 final domains including restrictions, seizure management, cognitive/executive functioning, social, sleep/fatigue, and mood/behavior. Patient self-report versions ranged from 30 to 33 items and parent proxy-report versions ranged from 26 to 33 items, with the toddler and young child versions having fewer items. CONCLUSIONS: Standardized qualitative methodology was employed to develop the items and content for the novel PedsQL™ Epilepsy Module. The PedsQL™ Epilepsy Module has the potential to enhance clinical decision-making in pediatric epilepsy by capturing and monitoring important patient-identified contributors to HRQOL.

A pilot randomized controlled clinical trial to improve antiepileptic drug adherence in young children with epilepsy.

The primary aim was to examine the preliminary efficacy of a family tailored problem-solving intervention to improve antiepileptic drug (AED) adherence in families of children with new-onset epilepsy. Secondary aims were to assess changes in targeted mechanisms and treatment feasibility and acceptability. Fifty families (M(age) = 7.6 ± 3.0; 80% Caucasian; 42% idiopathic localization related) completed baseline questionnaires and were given an electronic monitor to observe daily AED adherence. If adherence was ≤ 95% in the first 7 months of the study, families were randomized (Supporting Treatment Adherence Regimens (STAR): n = 11; Treatment as Usual (TAU): n = 12). Twenty-one families were not randomized due to adherence being ≥95%. The STAR intervention included four face-to-face and two telephone problem-solving sessions over 8 weeks. Significant group differences in adherence were found during active intervention (weeks 4-6; TAU = -12.0 vs. STAR = 18.1, p < 0.01; and weeks session 6-8: TAU = -9.7 vs. STAR = 15.3, p < 0.05). Children who received the STAR intervention exhibited improved adherence compared to children in the TAU group during active treatment. Significant changes in epilepsy knowledge and management were noted for the STAR group. Families expressed benefitting from the STAR intervention. Future studies should include a larger sample size and booster intervention sessions to maintain treatment effects over time.

Quality of Life Changes and Health Care Charges Among Youth With Epilepsy.

OBJECTIVE: To examine differences in health care charges following a pediatric epilepsy diagnosis based on changes in health-related quality of life (HRQOL). METHODS: Billing records were obtained for 171 youth [M (SD) age = 8.9 (4.1) years] newly diagnosed with epilepsy. Differences in health care charges among HRQOL groups (stable low, declining, improving, or stable high as determined by PedsQL(™) scores at diagnosis and 12 months after diagnosis) were examined. RESULTS: Patients with persistently low or declining HRQOL incurred higher total health care charges in the year following diagnosis (g = .49, g = .81) than patients with stable high HRQOL after controlling for epilepsy etiology, seizure occurrence, and insurance type. These relationships remained consistent after excluding health care charges for behavioral medicine or neuropsychology services (g = .49, g = .80). CONCLUSIONS: Monitoring HRQOL over time may identify youth with epilepsy at particular risk for higher health care charges.

Psychometric validation of the Pediatric Symptom Checklist-17 in a pediatric population with epilepsy: A methods study.

OBJECTIVE: The purpose of this study was to address critical gaps in behavioral health care of youth with epilepsy by examining the utility of a brief, well-validated screening instrument, the PSC-17, in a pediatric population with epilepsy. METHOD: One hundred eighty-seven caregivers of youth with epilepsy ages 2-17years completed the PSC-17 for their child/adolescent during a routine epilepsy visit. Demographic and seizure information was abstracted from electronic medical record review. RESULTS: Confirmatory factor analyses for the PSC-17 revealed an acceptable fit with the 3-factor model, χ(2) (116 [N=187]=204.54, p<0.001, CFI=0.90, TLI=0.88, RMSEA=0.064, SRMSR=0.078). Scale level reliabilities were excellent (0.72-0.85). Interscale correlations were moderate (0.48-0.69). Approximately 1/5th of the sample met clinical cut-offs for the total score of behavioral health concerns. However, an additional 20% of the sample had at least one elevated subscale score despite the total score being in the normative/nonclinical range. SIGNIFICANCE: The PSC-17 is a brief, free behavioral health screening tool with adequate to strong validity, reliability, and clinical utility for pediatric populations with epilepsy. Clinicians should consider using the 3 PSC-17 subscale scores instead of the total score to guide referrals for further evaluation as the subscales may provide a more accurate picture of functioning in particular domains.