OBJECTIVE: To evaluate long-term efficacy, safety, and tolerability, including behavior and executive functioning, during adjunctive lacosamide (LCM) treatment in pediatric patients (≥1 month to <18 years of age) with focal-onset or generalized seizures enrolled in 2 open-label, long-term follow-up trials.
METHODS: Two open-label extension trials (SP848: NCT00938912; EP0034: NCT01964560) were conducted in pediatric patients who had participated in previous trials of adjunctive LCM (SP0847/NCT00938431; SP0966/NCT01969851; EP0060/NCT02710890; SP0967/NCT02477839; SP0969/NCT01921205); SP848 also directly enrolled eligible pediatric patients who had not previously participated in a clinical trial of LCM. Outcomes included retention, efficacy, and safety/tolerability. Patient improvement was assessed with Clinician\'s and Caregiver\'s Global Impression of Change scale. Behavior and emotional function was assessed with Achenbach Child Behavior Checklist (CBCL) and executive functioning was assessed with Behavior Rating Inventory of Executive Function® (BRIEF).
RESULTS: The pooled dataset from both trials included 905 patients (851 in the focal-onset seizure population and 47 in the generalized seizure population). In the overall population, Kaplan-Meier-estimated 1-year retention was 80 %. From baseline to the end of the treatment period, patients in the focal-onset seizure population had a median percent reduction in focal-onset seizure frequency per 28 days of 60.4 %, 55.4 % of patients were 50 % responders, and 40.8 % of patients were 75 % responders. In patients with ≥12 months of LCM treatment, ≥12 month seizure freedom during the LCM treatment period was achieved by 29.9 % of patients in the focal-onset seizure population (median duration of first ≥12-month seizure-free interval: 641 days) and 24.4 % of patients in the generalized seizure population (median duration of first ≥12-month seizure-free interval: 665 days). Improvement during LCM treatment was reported in >75 % of patients by both physicians and caregivers. Treatment-emergent adverse events (TEAEs) were reported by 749 (82.8 %) patients, most commonly pyrexia (18.9 %), upper respiratory tract infection (18.6 %), nasopharyngitis (16.2 %), vomiting (15.7 %), and somnolence (11.8 %). The most common drug-related TEAEs were somnolence (8.5 %), dizziness (7.6 %), and vomiting (5.4 %). Behavioral and emotional function was generally stable in patients 1.5-5 years of age and slightly improved in patients ≥6 years of age, and executive functioning was stable in patients <5 years of age and generally slightly improved in patients 5-18 years of age.
CONCLUSIONS: In this analysis of a large patient pool from 2 open-label trials, long-term adjunctive LCM was efficacious and generally well tolerated in children with epilepsy and focal-onset or generalized seizures. Behavior and executive functioning were generally stable without observable worsening during long-term adjunctive LCM treatment.

OBJECTIVE: Most children who enter out-of-home care (OHC) have been subjected to prolonged maltreatment. Maltreatment potentially contributes to a cumulative deficit in neurocognitive maturation and development that is likely to proceed with the child\'s placement into OHC and persist throughout adulthood. From the theoretical perspective of how maltreatment may affect the developing brain, this study examines the IQ and executive function of children placed in OHC on standardized, norm-referenced measures. Furthermore, the study investigates the prevalence of serious cognitive delays, defined by scores in the clinical range on the administered instruments.
METHODS: The study included 153 children in foster care (66% female), aged 6-15 (M = 10.5, SD = 2.1). Independent two-sample t-tests were run to test for significant differences between the sample and the norm population on the applied neuropsychological measures.
RESULTS: The results showed that discrepancies in cognitive development were global in scope, with the children lagging significantly behind the norm population on all applied measures with discrepancies ranging from 0.61 to 2.10 SD (p < .001). Also, serious developmental delays in all cognitive domains were vastly overrepresented in the sample ranging from 11.3% (IQ) to 66.0% (executive function).
CONCLUSIONS: The results document a very high prevalence of cognitive deficits and delays among the children in the sample. The implications of identifying the neurocognitive effects of maltreatment in the practices of the child welfare system are discussed in terms of developing suitable assessment and intervention strategies.

The Pediatric Quality of Life Inventory-Cognitive Functioning Scale (PedsQLTM-CFS) was developed as a brief, general, symptom-specific tool to measure cognitive function. The 6-item PedsQL™ Cognitive Functioning Scale and PedsQL 3.0 Cancer Module answered 369 parents and 330 children with 5-18 years. Parents also completed Behavior Rating Inventory of Executive Function (BRIEF). The PedsQL™ Cognitive Functioning Scale evidenced excellent reliability (parent proxy-report α = 0.980/Fleiss Kappa: 0.794; children self-report α = 0.963/Fleiss Kappa: 0.790). Both child self-report and parent proxy-report PedsQL™ Cognitive Functioning Scale scores exhibited significant correlations with all parent-report BRIEF summary and subscale scores (p < .05). Both child self-report and parent proxy-report PedsQL™ Cognitive Functioning Scale scores exhibited significant correlations with PedsQL 3.0 Cancer Module total score and subscale scores (p < .05). The PedsQLTM-CFS can be used in high-risk populations with substantial to perfect reliability, both in regards to total/subcategory scores as well as in children with cancer.

OBJECTIVE: While neurodevelopmental symptoms are often seen in children of mothers with epilepsy, research specifically addressing executive function (EF) in this population is limited. This study aims to investigate EF in children of mothers with epilepsy, both with and without fetal exposure to anti-seizure medications, compared to typically developing children whose mothers do not have epilepsy.
METHODS: We evaluated EF in children aged 8 to 17 years born to mothers with clinically validated diagnoses of epilepsy, using the Behavior Rating Inventory of Executive Function completed by the mothers. The results were then compared to a typically developing control group at the same age living in the same geographic area.
RESULTS: The results showed significantly higher levels of EF problems in children of mothers with epilepsy who were exposed (p = 0.005, d = 0.63), and unexposed (p = 0.001, d = 0.74) to anti-seizure medications during pregnancy, compared to typically developing children. There was no significant difference in EF problems between the exposed and unexposed groups. These findings remained statistically significant after adjusting for mothers\' education levels, and when excluding participants exposed to valproate during pregnancy.
CONCLUSIONS: This study highlights the increased risk of EF problems in children of mothers with epilepsy, independent of exposure to anti-seizure medications. Findings underscore the importance of continuous monitoring of EF in these children and highlights the need for further research into the diverse factors affecting EF development in this group.

The objective of this study was to assess the efficacy of the Play Nicely brief intervention in diminishing both the utilization of physical punishment and the beliefs that endorse such behavior among a sample of Colombian parents with children aged 2 to 6. Utilizing a quasi-experimental design, the research included pretest and posttest evaluations and involved both an intervention group (n = 37) and a control group (n = 29). The assessment tools used were a scale to measure beliefs about the positive impacts of physical punishment and the Physical Assault subscale of the Spanish version of the Conflict Tactics Scale Parent-Child (CTSPC). Parents participated in a single online session, which offered eight interactive options and lasted 10 min. The results highlighted a high prevalence of physical punishment within the sample (81.8%) and established statistically significant correlations between the justification of physical punishment and its actual use. Approximately one month following the intervention, there was a significant reduction in the employment of physical punishment among the intervention group (p = 0.009), and a notable decrease in the belief that \"Punishment is the best alternative to control children\'s behavior\" (p = 0.010) was observed. Consequently, the Play Nicely intervention proved effective in curtailing the use of physical punishment among parents of young children, demonstrating both efficacy and cost-effectiveness within a brief timeframe.

UNASSIGNED: Replicated evidence shows a weak or non-significant correlation between different methods of evaluating executive functions (EF). The current study investigates the association between rating scales and cognitive tests of EF in a sample of children with ADHD and executive dysfunction.
UNASSIGNED: The sample included 139 children (aged 6-13) diagnosed with ADHD and executive dysfunctions. The children completed subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Parents completed the Behavior Rating Inventory of Executive Function (BRIEF) and the Children\'s Organizational Skills Scale (COSS).
UNASSIGNED: Pairwise Spearman correlations were calculated between the composite and separate subscales of cognitive tests and rating scales. In secondary analyses, pairwise Spearman correlations were conducted between all composite scales and subscales, stratified by child sex and child ADHD subtype.
UNASSIGNED: The correlation analyses between composite scores yielded no significant correlations. The results when comparing CANTAB TO and BRIEF GE are r=-.095, p=.289, and r=.042, p=.643 when comparing CANTAB TO and COSS TO. The analyses between all composite scales and subscales found one significant negative correlation (r=-.25, p<.01). There are significant cross-method differences when stratified by the ADHD-Inattentive subtype, showing significant negative correlations (moderate) between CANTAB and BRIEF composite (r=-.355, p=.014) and subscales.
UNASSIGNED: It is possible that the different methods measure different underlying constructs of EF. It may be relevant to consider the effects of responder bias and differences in ecological validity in both measurement methods.
UNASSIGNED: The results found no significant correlations. The expectation in research and clinical settings should not be to find the same results when comparing data from cognitive tests and rating scales. Future research might explore novel approaches to EF testing with a higher level of ecological validity, and designing EF rating scales that capture EF behaviors more so than EF cognition.

BACKGROUND: Preliminary evidence shows promising treatment outcomes at short-term follow-up for intensive posttraumatic stress disorder (PTSD) treatment, but long-term follow-up studies are sparse. This study is a sequel to a previous pilot study and open trial, set out to investigate treatment outcomes at 12-month follow-up for outpatients completing an 8-day intensive treatment for PTSD.
METHODS: All patients were diagnosed with PTSD and had multiple previous psychotherapy attempts (M = 3.1). Patients were assessed at pre-treatment, post-treatment, 3- and 12-month follow-up. Of 35 treated patients, 32 (91.4%) attended the long-term follow-up assessment. The treatment programme combined prolonged exposure therapy, eye movement desensitization and reprocessing, and physical activity.
RESULTS: The effect sizes indicated large reductions in symptoms of PTSD, depression, anxiety, interpersonal problems, and well-being. Changes in functioning showed a small-medium effect. Results were stable across the follow-up period. The treatment response rates showed that 46-60% of patients achieved recovery with respect to PTSD symptoms, and that 44-48% no longer met diagnostic criteria for PTSD.
CONCLUSIONS: Time-limited and concentrated outpatient treatment for PTSD can yield large and enduring positive outcomes. Controlled trials are needed to establish relative efficacy.
BACKGROUND: The study was registered in Current Research Information System In Norway (Cristin). Cristin-project-ID: 654,790. Date of registration: 18.03.2019.

BACKGROUND: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. This protocol paper describes a two-arm, multi-center, randomized controlled trial on the short- and longer-term effectiveness and cost-effectiveness of a brief, individually tailored behavioral parent training program for children with behavioral difficulties.
METHODS: Parents of children aged 2-12 years referred to a child mental healthcare center are randomized to (i) three sessions of behavioral parent training with optional booster sessions or (ii) care as usual. To evaluate effectiveness, our primary outcome is the mean severity of five daily ratings by parents of four selected behavioral difficulties. Secondary outcomes include measures of parent and child behavior, well-being, and parent-child interaction. We explore whether child and parent characteristics moderate intervention effects. To evaluate cost-effectiveness, the use and costs of mental healthcare and utilities are measured. Finally, parents\' and therapists\' satisfaction with the brief program are explored. Measurements take place at baseline (T0), one week after the brief parent training, or eight weeks after baseline (in case of care as usual) (T1), and six months (T2) and twelve months (T3) after T1.
CONCLUSIONS: The results of this trial could have meaningful societal implications for children with behavioral difficulties and their parents. If we find the brief behavioral parent training to be more (cost-)effective than care as usual, it could be used in clinical practice to make parent training more accessible.
BACKGROUND: The trial is prospectively registered at ClinicalTrials.gov (NCT05591820) on October 24th, 2022 and updated throughout the trial.

UNASSIGNED: We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.
UNASSIGNED: Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.
UNASSIGNED: Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.
UNASSIGNED: The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.

UNASSIGNED: We leveraged common genetic variation underlying ADHD, educational attainment (EA) and cognition (COG) to understand the nature of the Behavior Rating Inventory for Executive Functions (BRIEF) and its relationship to academic functioning.
UNASSIGNED: Participants were 991 youth, ages 7 to 17, consecutively referred for neuropsychiatric evaluation. Polygenic scores (PGS) for ADHD, EA, and COG were related to the BRIEF using regression analyses. Structural equation models were used to examine the associations between the PGS, BRIEF and academic outcomes (math, reading, and special education services [EDPLAN]).
UNASSIGNED: After modeling the PGS together, only the EA and ADHD PGS significantly associated with the BRIEF. The BRIEF partially mediated the relationships between EA PGS with math and EDPLAN and fully mediated the relationship between ADHD PGS and EDPLAN.
UNASSIGNED: Genetic data extend evidence that the BRIEF measures a construct relevant to educational success that differs from what is indexed by cognitive testing.