Background: In situations of ongoing violence, childhood psychosocial and mental health problems require care. However, resources and evidence for adequate interventions are scarce for children in ...low‐ and middle‐income countries. This study evaluated a school‐based psychosocial intervention in conflict‐affected, rural Nepal.
Methods: A cluster randomized controlled trial was used to evaluate changes on a range of indicators, including psychiatric symptoms (depression, anxiety, posttraumatic stress disorder), psychological difficulties, resilience indicators (hope, prosocial behavior) and function impairment. Children (n = 325) (mean age = 12.7, SD = 1.04, range 11–14 years) with elevated psychosocial distress were allocated to a treatment or waitlist group.
Results: Comparisons of crude change scores showed significant between‐group differences on several outcome indicators, with moderate effect sizes (Cohen d = .41 to .58). After correcting for nested variance within schools, no evidence for treatment effects was found on any outcome variable. Additional analyses showed gender effects for treatment on prosocial behavior (mean change difference: 2.70; 95% CI, .97 to 4.44), psychological difficulties (−2.19; 95% CI, −3.82 to −.56), and aggression (−4.42; 95% CI, −6.16 to −2.67). An age effect for treatment was found for hope (.90; 95% CI, −1.54 to −.26).
Conclusions: A school‐based psychosocial intervention demonstrated moderate short‐term beneficial effects for improving social‐behavioral and resilience indicators among subgroups of children exposed to armed conflict. The intervention reduced psychological difficulties and aggression among boys, increased prosocial behavior among girls, and increased hope for older children. The intervention did not result in reduction of psychiatric symptoms.
Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents. We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms ...of posttraumatic stress disorder, depression, and anxiety (treatment aim); and improving a sense of hope and functioning (preventive aim).
We conducted a cluster randomized trial with 329 children in war-affected Burundi (aged 8 to 17 (mean 12.29 years, standard deviation 1.61); 48% girls). One group of children (n = 153) participated in a 15-session school-based intervention implemented by para-professionals, and the remaining 176 children formed a waitlist control condition. Outcomes were measured before, one week after, and three months after the intervention.
No main effects of the intervention were identified. However, longitudinal growth curve analyses showed six favorable and two unfavorable differences in trajectories between study conditions in interaction with several moderators. Children in the intervention condition living in larger households showed decreases on depressive symptoms and function impairment, and those living with both parents showed decreases on posttraumatic stress disorder and depressive symptoms. The groups of children in the waitlist condition showed increases in depressive symptoms. In addition, younger children and those with low levels of exposure to traumatic events in the intervention condition showed improvements on hope. Children in the waitlist condition who lived on their original or newly bought land showed improvements in hope and function impairment, whereas children in the intervention condition showed deterioration on these outcomes.
Given inconsistent effects across studies, findings do not support this school-based intervention as a treatment for posttraumatic stress disorder and depressive symptoms in conflict-affected children. The intervention appears to have more consistent preventive benefits, but these effects are contingent upon individual (for example, age, gender) and contextual (for example, family functioning, state of conflict, displacement) variables. Results suggest the potential benefit of school-based preventive interventions particularly in post-conflict settings.
The study was registered as ISRCTN42284825.
Little is known about the efficacy of mental health interventions for children exposed to armed conflicts in low- and middle-income settings. Childhood mental health problems are difficult to address ...in situations of ongoing poverty and political instability.
To assess the efficacy of a school-based intervention designed for conflict-exposed children, implemented in a low-income setting.
A cluster randomized trial involving 495 children (81.4% inclusion rate) who were a mean (SD) age of 9.9 (1.3) years, were attending randomly selected schools in political violence-affected communities in Poso, Indonesia, and were screened for exposure (> or = 1 events), posttraumatic stress disorder, and anxiety symptoms compared with a wait-listed control group. Nonblinded assessment took place before, 1 week after, and 6 months after treatment between March and December 2006.
Fifteen sessions, over 5 weeks, of a manualized, school-based group intervention, including trauma-processing activities, cooperative play, and creative-expressive elements, implemented by locally trained paraprofessionals.
We assessed psychiatric symptoms using the Child Posttraumatic Stress Scale, Depression Self-Rating Scale, the Self-Report for Anxiety Related Disorders 5-item version, and the Children's Hope Scale, and assessed function impairment as treatment outcomes using standardized symptom checklists and locally developed rating scales.
Correcting for clustering of participants within schools, we found significantly more improvement in posttraumatic stress disorder symptoms (mean change difference, 2.78; 95% confidence interval CI, 1.02 to 4.53) and maintained hope (mean change difference, -2.21; 95% CI, -3.52 to -0.91) in the treatment group than in the wait-listed group. Changes in traumatic idioms (stress-related physical symptoms) (mean change difference, 0.50; 95% CI, -0.12 to 1.11), depressive symptoms (mean change difference, 0.70; 95% CI, -0.08 to 1.49), anxiety (mean change difference, 0.12; 95% CI, -0.31 to 0.56), and functioning (mean change difference, 0.52; 95% CI, -0.43 to 1.46) were not different between the treatment and wait-listed groups.
In this study of children in violence-affected communities, a school-based intervention reduced posttraumatic stress symptoms and helped maintain hope, but did not reduce traumatic-stress related symptoms, depressive symptoms, anxiety symptoms, or functional impairment.
isrctn.org Identifier: ISRCTN25172408.
Objectives To determine whether social determinants of health (SDH) risk adjustment changes hospital-level performance on the 30-day Pediatric All-Condition Readmission (PACR) measure and improves ...fit and accuracy of discharge-level models. Study design We performed a retrospective cohort study of all hospital discharges meeting criteria for the PACR from 47 hospitals in the Pediatric Health Information database from January to December 2014. We built four nested regression models by sequentially adding risk adjustment factors as follows: chronic condition indicators (CCIs); PACR patient factors (age and sex); electronic health record-derived SDH (race, ethnicity, payer), and zip code-linked SDH (families below poverty level, vacant housing units, adults without a high school diploma, single-parent households, median household income, unemployment rate). For each model, we measured the change in hospitals' readmission decile-rank and assessed model fit and accuracy. Results For the 458 686 discharges meeting PACR inclusion criteria, in multivariable models, factors associated with higher discharge-level PACR measure included age <1 year, female sex, 1 of 17 CCIs, higher CCI count, Medicaid insurance, higher median household income, and higher percentage of single-parent households. Adjustment for SDH made small but significant improvements in fit and accuracy of discharge-level PACR models, with larger effect at the hospital level, changing decile-rank for 17 of 47 hospitals. Conclusions We found that risk adjustment for SDH changed hospitals' readmissions rate rank order. Hospital-level changes in relative readmissions performance can have considerable financial implications; thus, for pay for performance measures calculated at the hospital level, and for research associated therewith, our findings support the inclusion of SDH variables in risk adjustment.
We aimed to examine outcomes, moderators and mediators of a preventive school-based mental health intervention implemented by paraprofessionals in a war-affected setting in northern Sri Lanka. A ...cluster randomized trial was employed. Subsequent to screening 1,370 children in randomly selected schools, 399 children were assigned to an intervention (n=199) or waitlist control condition (n=200). The intervention consisted of 15 manualized sessions over 5 weeks of cognitive behavioral techniques and creative expressive elements. Assessments took place before, 1 week after, and 3 months after the intervention. Primary outcomes included post-traumatic stress disorder (PTSD), depressive, and anxiety symptoms. No main effects on primary outcomes were identified. A main effect in favor of intervention for conduct problems was observed. This effect was stronger for younger children. Furthermore, we found intervention benefits for specific subgroups. Stronger effects were found for boys with regard to PTSD and anxiety symptoms, and for younger children on pro-social behavior. Moreover, we found stronger intervention effects on PTSD, anxiety, and function impairment for children experiencing lower levels of current war-related stressors. Girls in the intervention condition showed smaller reductions on PTSD symptoms than waitlisted girls. We conclude that preventive school-based psychosocial interventions in volatile areas characterized by ongoing war-related stressors may effectively improve indicators of psychological wellbeing and posttraumatic stress-related symptoms in some children. However, they may undermine natural recovery for others. Further research is necessary to examine how gender, age and current war-related experiences contribute to differential intervention effects.
Objective:
The authors examined moderators and mediators of a school-based psychosocial intervention for children affected by political violence, according to an ecological resilience theoretical ...framework.
Method:
The authors examined data from a cluster randomized trial, involving children aged 8-13 in Central Sulawesi, Indonesia (treatment condition
n
= 182, waitlist control condition
n
= 221). Mediators (hope, coping, peer/emotional/play social support) and moderators (gender, age, family connectedness, household size, other forms of social support, exposure to political violence, and displacement) of treatment outcome on posttraumatic stress symptoms and function impairment were examined in parallel process latent growth curve models.
Results:
Compared with the waitlist group, those receiving treatment showed maintained hope, increased positive coping, maintained peer social support, and increased play social support. Of these putative mediators, only play social support was found to mediate treatment effects, such that increases in play social support were associated with smaller reductions in posttraumatic stress disorder (PTSD) symptoms. Furthermore, the authors identified a number of moderators: Girls showed larger treatment benefits on PTSD symptoms; girls, children in smaller households, and children receiving social support from adults outside the household showed larger treatment benefits on function impairment.
Conclusions:
Findings provide limited evidence for an ecological resilience theoretical framework. On the basis of these findings, the authors recommend a stronger separation between universal prevention (e.g., resilience promotion through play) and selective/indicated prevention (e.g., interventions aimed at decreasing posttraumatic stress symptoms). Play-based interventions should be careful to exclude children with psychological distress. In addition, treatment effects may be augmented by selecting girls and socially vulnerable children.
Abstract Aim Dalotuzumab is a highly specific, humanised immunoglobulin G1 monoclonal antibody against insulin-like growth factor receptor 1. This multicenter phase 1 study ( NCT01431547 ) explored ...the safety and pharmacokinetics of dalotuzumab monotherapy (part 1) and the combination of dalotuzumab with the mammalian target of rapamycin inhibitor ridaforolimus (part 2) in paediatric patients with advanced solid tumours. Methods Dalotuzumab was administered intravenously every 3 weeks starting at 900 mg/m2 and escalating to 1200 and 1500 mg/m2 . Combination therapy included intravenous dalotuzumab at the defined single-agent recommended phase 2 dose (RP2D) and oral ridaforolimus 28 mg/m2 daily (days 1–5), repeated weekly. Pharmacokinetic studies were performed to evaluate the mean serum trough dalotuzumab concentration, which guided the RP2D. Results Twenty-four patients were enrolled (part 1, n = 20; part 2, n = 4). No dose-limiting toxicities were observed in patients receiving dalotuzumab alone. One patient experienced dose-limiting stomatitis in the combination arm. Pharmacokinetic data showed dose-dependent increases in exposure (area under the curve from zero to infinity AUC0–∞ ) (87,900, 164,000, and 186,000 h*mg/ml for the 900, 1200, and 1500 mg/m2 dose levels, respectively), maximum serum concentration (Cmax ) (392, 643, and 870 mg/ml), and serum trough concentration (Ctrough ) (67.1, 71.6, and 101 mg/ml). The mean half-life was 265, 394, and 310 h, respectively. Dalotuzumab pharmacokinetics were not affected by coadministration with ridaforolimus. One of six patients with Ewing sarcoma had confirmed partial response to dalotuzumab monotherapy at 900 mg/m2 . Time to response was 41 d, and progression occurred at 126 d. Conclusion Dalotuzumab was well tolerated in paediatric patients with advanced solid malignancies. The RP2D of dalotuzumab is 900 mg/m2 ( ClinicalTrials.gov identifier: NCT01431547 , Protocol PN062).
Objective To determine if household income is associated with hospitalization costs for severe traumatic brain injury (TBI) and spinal cord injury (SCI). Study design Retrospective cohort study of ...inpatient, nonrehabilitation hospitalizations at 43 freestanding children's hospitals for patients <19 years old with unintentional severe TBI and SCI from 2009-2012. Standardized cost of care for hospitalizations was modeled using mixed-effects methods, adjusting for age, sex, race/ethnicity, primary payer, presence of chronic medical condition, mechanism of injury, injury severity, distance from residence to hospital, and trauma center level. Main exposure was zip code level median annual household income. Results There were 1061 patients that met inclusion criteria, 833 with TBI only, 227 with SCI only, and 1 with TBI and SCI. Compared with those with the lowest-income zip codes, patients from the highest-income zip codes were more likely to be older, white (76.7% vs 50.4%), have private insurance (68.9% vs 27.9%), and live closer to the hospital (median distance 26.7 miles vs 81.2 miles). In adjusted models, there was no significant association between zip code level household income and hospitalization costs. Conclusions Children hospitalized with unintentional, severe TBI and SCI showed no difference in standardized hospital costs relative to a patient's home zip code level median annual household income. The association between household income and hospitalization costs may vary by primary diagnosis.
Purpose
To describe a novel technique in unfolding an endothelium-in Descemet membrane (DM) graft.
Methods
New surgical technique description
Results
We describe a novel technique that allows ...immediate and controlled unfolding of the endothelium-in Descemet membrane graft that was successful in 5 of our DMEK patients. It is essential to acquire this “side press-and-release” technique when the graft does not unfold spontaneously as expected.
Conclusions
This controlled and simple manoeuvre is an efficient and safe method of unfolding an endothelium-in DM graft.
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