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The Publisher's final version can be found by following the DOI link. Open access article. Background Severe mental illness is a major driver of worldwide disease burden. Shared decision-making is critical for high quality care, and can enhance patient satisfaction and outcomes. However, it has not been translated into routine practice. This reflects a lack of evidence on the best way to implement shared decision-making, and the challenges of implementation in routine settings with limited resources. Our aim was to test whether we could deliver a practical and feasible intervention in routine community mental health services to embed shared decision-making for patients with severe mental illness, by improving patient and carer involvement in care planning. Methods We cluster randomised community mental health teams to the training intervention or usual care, to avoid contamination. Training was co-delivered to a total of 350 staff in 18 teams by clinical academics, working alongside patients and carers. The primary outcome was the Health Care Climate Questionnaire, a self-report measure of `autonomy support'. Primary and secondary outcomes were collected by self-report, six months after allocation. Findings In total, 604 patients and 90 carers were recruited to main trial cohort. Retention at six months was 82% (n = 497). In the main analysis, results showed no statistically significant difference in the primary outcome between the intervention and usual care at 6 months (adjusted mean difference -0.064, 95% CI -0.343 to 0.215, p = 0.654). We found significant effects on only 1 secondary outcome. Conclusions An intervention to embed shared decision-making in routine practice by improving involvement in care planning was well attended and acceptable to staff, but had no significant effects on patient outcomes. Enhancing shared decision-making may require considerably greater investment of resources and effects may only be apparent over the longer term.

Over half of all children with autism spectrum disorders (ASD) have gastrointestinal (GI) co-morbidities including chronic constipation, diarrhea, and irritable bowel syndrome. The severity of these symptoms has been correlated with the degree of GI microbial dysbiosis. The study objective was to assess tolerability of a probiotic (Bifidobacterium infantis) in combination with a bovine colostrum product (BCP) as a source of prebiotic oligosaccharides and to evaluate GI, microbiome and immune factors in children with ASD and GI co-morbidities. This pilot study is a randomized, double blind, controlled trial of combination treatment (BCP + B. infantis) vs. BCP alone in a cross-over study in children ages 2-11 with ASD and GI co-morbidities (n = 8). This 12-week study included 5 weeks of probiotic-prebiotic supplementation, followed by a two-week washout period, and 5 weeks of prebiotic only supplementation. The primary outcome of tolerability was assessed using validated questionnaires of GI function and atypical behaviors, along with side effects. Results suggest that the combination treatment is well-tolerated in this cohort. The most common side effect was mild gassiness. Some participants on both treatments saw a reduction in the frequency of certain GI symptoms, as well as reduced occurrence of particular aberrant behaviors. Improvement may be explained by a reduction in IL-13 and TNF-α production in some participants. Although limited conclusions can be drawn from this small pilot study, the results support the need for further research into the efficacy of these treatments.

Author(s): Hessl, David; Harvey, Danielle; Sansone, Stephanie; Crestodina, Crystal; Chin, Jamie; Joshi, Reshma; Hagerman, Randi J; Berry-Kravis, Elizabeth | Abstract: BackgroundNumerous preclinical studies have supported the theory that enhanced activation of mGluR5 signaling, due to the absence or reduction of the FMR1 protein, contributes to cognitive and behavioral deficits in patients with fragile X syndrome (FXS). However multiple phase 2 controlled trials in patients with FXS have failed to demonstrate efficacy of compounds that negatively modulate mGluR5, including two phase 2b randomized controlled trials (RCT) of mavoglurant (AFQ056, Novartis Pharma AG), when the primary measures of interest were behavioral ratings. This has cast some doubt onto the translation of the mGluR5 theory from animal models to humans with the disorder.MethodsWe evaluated social gaze behavior-a key phenotypic feature of the disorder-and sympathetic nervous system influence on pupil size using a previously-validated eye tracking paradigm as a biobehavioral probe, in 57 adolescent or adult patients with FXS at baseline and following three months of blinded treatment with one of three doses of mavoglurant or placebo, within the context of the AFQ056 RCTs.ResultsPatients with FXS treated with mavoglurant demonstrated increased total absolute looking time and number of fixations to the eye region while viewing human faces relative to baseline, and compared to those treated with placebo. In addition, patients had greater pupil reactivity to faces relative to baseline following mavoglurant treatment compared to placebo.DiscussionThe study shows that negative modulation of mGluR5 activity improves eye gaze behavior and alters sympathetically-driven reactivity to faces in patients with FXS, providing preliminary evidence of this drug's impact on behavior in humans with the disorder.

Private-sector investors could be key players in combatting global land degradation and realising the emerging concept of Land Degradation Neutrality (LDN). To better understand how to incentivize private-sector investors for LDN, we conducted an online-survey of 68 private-sector investors. Structural equation modelling based on the theory of planned behavior was performed to investigate how cognitive, social, emotional, motivational and financial determinants influence their intention and motivation to invest in LDN. Good knowledge and a positive attitude towards both LDN and investing sustainably were found to be main predictors for intention. In contrast, perceived social pressure had little effect on the intention to invest towards combating land degradation. The general motivation to invest sustainably was mainly triggered by a consciousness for sustainability and emotional attachment, less by the desire for short-term profit maximisation whilst prospects of long-term financial return are important. Overall, strong homogeneity in psychological determinants was found for both traditional and impact investors. As the determinants of the intention and the motivation to invest sustainably do not substantially differ across different investor types, our study implies that investors should be targeted as a uniform group when mobilising interest for LDN. Emphasis should be placed on the psychological determinants traditional and impact investors commonly share, rather than on the type-specific characteristics that may distinguish different investor types., PLoS ONE, 13 (12), ISSN:1932-6203

Author(s): Pitpitan, Eileen V; Semple, Shirley J; Aarons, Gregory A; Palinkas, Lawrence A; Chavarin, Claudia V; Mendoza, Doroteo V; Magis-Rodriguez, Carlos; Staines, Hugo; Patterson, Thomas L | Abstract: ObjectiveThe overall aim of this paper is to examine effectiveness of an evidence-based intervention in community settings, and the factors associated with effectiveness. Limited research in the area of HIV prevention has focused on evaluating intervention program effectiveness in real-world settings.MethodsWe implemented an efficacious theory-based sexual risk reduction intervention for female sex workers (FSW) called Mujer Segura across 13 different clinics in 13 sites across Mexico. The overall design was a cluster randomized Type I design simultaneously testing intervention program effectiveness with an observational study of implementation factors. We aimed to examine the effectiveness of Mujer Segura at reducing HIV/STI incidence among FSW participants at each site, and to examine the client-, provider-, organization-, and structure-related factors associated with program effectiveness.ResultsWe found lower HIV/STI incidence density in the intervention relative to the control group in 5 sites we labeled as "program effective sites," but not in 8 sites we labeled as "program ineffective sites." Using generalized estimating equations controlling for site and computed mean difference effect sizes, we examined statistically and practically significant differences, respectively, between the two groups of sites along various client-, provider-, organization-, and structure-related characteristics. Results indicated that client-level HIV/AIDS related knowledge, and proficiency and engagement in the organizational social context were associated with program effectiveness.ConclusionsEnormous resources are required to systematically and adequately test the role of multilevel factors on program effectiveness. We successfully implemented Mujer Segura in 13 sites in Mexico. Results suggest that other measures may need to be included in future implementation studies than the ones included here. We were able to point to a few specific factors that should be targeted to increase effectiveness of similar evidence-based programs in low- and other middle-income countries like Mexico.Trial registrationClinicalTrials.gov NCT01465607.

BackgroundWhereas poor maternal nutritional status before and during pregnancy is widely associated with adverse birth outcomes, studies quantifying this association in low income countries are scarce. We examined whether maternal pre-pregnancy body mass index (BMI) and weight gain during pregnancy are associated with birth outcomes in rural Malawi.MethodsWe analyzed the associations between pre-pregnancy BMI and average weekly gestational weight gain (WWG) and birth outcomes [duration of gestation, birth weight, length-for-age z-score (LAZ), and head circumference-for-age z-score (HCZ)]. We also determined whether women with low or high pre-pregnancy BMI or women with inadequate or excessive WWG were at increased risk of adverse birth outcomes.ResultsThe analyses included 1287 women with a mean BMI of 21.8 kg/m2, of whom 5.9% were underweight (< 18.5 kg/m2), 10.9% were overweight (≥ 25 kg/m2), 71.8% had low WWG [below the lower limit of the Institute of Medicine (IOM) recommendation], and 5.2% had high WWG (above IOM recommendation). In adjusted models, pre-pregnancy BMI was not associated with duration of pregnancy (p = 0.926), but was positively associated with birth weight and HCZ (

Introduction Breastfeeding is recommended exclusively for the first 6 months after birth, with continued breastfeeding for at least 2 years. Yet prevalence of these recommendations is low globally, although it is an effective and cost-effective way to prevent serious infections and chronic illness. Previous studies have reported that social support greatly influences breastfeeding, but there is little evidence on perceived social norms in Mexico and how they affect actual behavior. Objective Our objective was to investigate breastfeeding intention, practices, attitudes, and beliefs, particularly normative, among low-resource communities in central and southern Mexico. Methods We performed a secondary analysis using the theory of planned behavior with cross-sectional data, which included semi-structured individual interviews with fathers (n 10), 8 focus groups with mothers (n 50), and 8 focus groups with women community leaders (n 44) with a total of 104 participants. Our data also included a quantitative survey among pregnant women and mothers (n 321). Results Women reported supplementing breast milk with water and teas soon after birth, as well as introducing small bites of solid food a few months after birth. Social norms appeared to support breastfeeding, but not exclusive breastfeeding or breastfeeding for periods longer than about a year. This may be partially explained by: a) behavioral beliefs that for the first 6 months breast milk alone is insufficient for the baby, and that water in addition to breast milk is necessary to hydrate an infant and b) normative beliefs related to the appropriateness of breastfeeding in public and as the child gets older. Conclusions Future strategies should focus on positively influencing social norms to support recommended practices, and emphasize the specific reasons behind the recommendations. Future efforts should take a multi-pronged approach using a variety of influences, not only directed at healthcare providers but close family members, including fathers.

BACKGROUND:In Mexico, although the majority of births are attended in hospitals, reports have emerged of obstetric violence, use of unsafe practices, and failure to employ evidence-based practices (EBP). Recent attention has refocused global efforts towards provision of quality care that is both patient-centered and evidence-based. Scaling up of local interventions should rely on strong evidence of effectiveness. OBJECTIVE:To perform a secondary analysis to evaluate the impact of a simulation and team-training program (PRONTO) on the performance of EBP in normal births. METHODS:A pair-matched cluster randomized controlled trial of the intervention was designed to measure the impact of the program (PRONTO intervention) on a sample of 24 hospitals (12 hospitals received the PRONTO training and 12 served as controls) in the states of Chiapas, Guerrero, and Mexico. We estimated the impact of receiving the intervention on the probability of birth practices performance in a sample of 641 observed births of which 318 occurred in the treated hospitals and 323 occurred in control hospitals. Data was collected at 4 time points (baseline, 4th, 8th and 12th months after the training). Women were blinded to treatment allocation but observers and providers were not. Estimates were obtained by fitting difference-in-differences logistic regression models considering confounding variables. The trial is registered at clinicaltrials.gov: # NCT01477554. RESULTS:Significant changes were found following the intervention. At 4 months post-intervention an increase of 20 percentage points (p.p.) for complete Active Management of Third Stage of Labor (AMTSL) (p = 0.044), and 16 p.p. increase for Skin-to-Skin Contact (p = 0.067); at 12 months a 25 p.p. increase of the 1st step of AMTSL (p = 0.026) and a 42 p.p. increase of Delayed Cord Clamping (p = 0.004); at 4 months a 30 (p = 0.001) and at 8 months a 22 (p = 0.010) p.p. decrease for Uterine Sweeping. CONCLUSIONS:The intervention has an impact on adopting EBP at birth, contributing to an increased quality of care. Long lasting impacts on these practices are possible if there were to be a widespread adoption of the training techniques including simulation, team-training and facilitated discussions regarding routine care.

Social support from peers and parents provides a key socialization function during adolescence. We examine adolescent friendship networks using a Stochastic Actor-Based modeling approach to observe the flow of emotional support provision to peers and the effect of support from parents, while simultaneously modeling smoking behavior. We utilized one school (n = 976) from The National Longitudinal Study of Adolescent to Adult Health (AddHealth) Study. Our findings suggest that emotional support is transacted through an interdependent contextual system, comprised of both peer and parental effects, with the latter also having distal indirect effects from youths' friends' parents.

Background : Of two community-based trials among young children in neighboring health districts of Burkina Faso, one found that small-quantity lipid-based nutrient supplements (LNS) increased child growth compared with a non-intervention control group, but zinc supplementation did not in the second study. Objectives : We explored whether the disparate growth outcomes were associated with differences in intervention components, household demographic variables, and/or children's morbidity. Methods : Children in the LNS study received 20g LNS daily containing different amounts of zinc (LNS). Children in the zinc supplementation study received different zinc supplementation regimens (Z-Suppl). Children in both studies were visited weekly for morbidity surveillance. Free malaria and diarrhea treatment was provided by the field worker in the LNS study, and by a village-based community-health worker in the zinc study. Anthropometric assessments were repeated every 13-16 weeks. For the present analyses, study intervals of the two studies were matched by child age and month of enrollment. The changes in length-for-age z-score (LAZ) per interval were compared between LNS and Z-Suppl groups using mixed model ANOVA or ANCOVA. Covariates were added to the model in blocks, and adjusted differences between group means were estimated. Results : Mean ages at enrollment of LNS (n = 1716) and Z-Suppl (n = 1720) were 9.4 +/- 0.4 and 10.1 +/- 2.7 months, respectively. The age-adjusted change in mean LAZ per interval declined less with LNS (-0.07 +/- 0.44) versus Z-Suppl (-0.21 +/- 0.43; p

BACKGROUND: Little is known about longitudinal changes in the Health Related Quality of Life (HRQoL) among children with migrant backgrounds. METHODS: The sample comprised 350 children with predominantly migrant backgrounds enrolled in 7 kindergartens in Frankfurt and Darmstadt, Germany. At baseline, the participants' mean age was 4.4 years (SD 0.9). Data collection started in May 2009. Two waves of data were collected one year apart (94% response rate). HRQoL was evaluated with the Kiddy-KINDL. The other variables under study were sex, age, socioeconomic status, country of origin, developmental status (WET) and individual behavior (VBV). Data were collected from the children, parents and teachers. Structural equation modeling (SEM) was used to assess the Wilson and Cleary theoretical framework on changes in HRQoL and Generalized Estimated Equations (GEE) to model the longitudinal trend in HRQoL. RESULTS: Overall HRQoL remained stable between baseline and follow-up. SEM model fit was χ2 = 8.51; df = 5; p = 0.13; SRMR = 0.02 RMSEA = 0.06 and indicated that there were differences in kindergarten activities (p

Children with Sensory Processing Dysfunction (SPD) experience incoming information in atypical, distracting ways. Qualitative challenges with attention have been reported in these children, but such difficulties have not been quantified using either behavioral or functional neuroimaging methods. Furthermore, the efficacy of evidence-based cognitive control interventions aimed at enhancing attention in this group has not been tested. Here we present work aimed at characterizing and enhancing attentional abilities for children with SPD. A sample of 38 SPD and 25 typically developing children were tested on behavioral, neural, and parental measures of attention before and after a 4-week iPad-based at-home cognitive remediation program. At baseline, 54% of children with SPD met or exceeded criteria on a parent report measure for inattention/hyperactivity. Significant deficits involving sustained attention, selective attention and goal management were observed only in the subset of SPD children with parent-reported inattention. This subset of children also showed reduced midline frontal theta activity, an electroencephalographic measure of attention. Following the cognitive intervention, only the SPD children with inattention/hyperactivity showed both improvements in midline frontal theta activity and on a parental report of inattention. Notably, 33% of these individuals no longer met the clinical cut-off for inattention, with the parent-reported improvements persisting for 9 months. These findings support the benefit of a targeted attention intervention for a subset of children with SPD, while simultaneously highlighting the importance of having a multifaceted assessment for individuals with neurodevelopmental conditions to optimally personalize treatment.

Author(s): Parga, Joanna J; Daland, Robert; Kesavan, Kalpashri; Macey, Paul M; Zeltzer, Lonnie; Harper, Ronald M | Abstract: ObjectiveReducing environmental noise benefits premature infants in neonatal intensive care units (NICU), but excessive reduction may lead to sensory deprivation, compromising development. Instead of minimal noise levels, environments that mimic intrauterine soundscapes may facilitate infant development by providing a sound environment reflecting fetal life. This soundscape may support autonomic and emotional development in preterm infants. We aimed to assess the efficacy and feasibility of external non-invasive recordings in pregnant women, endeavoring to capture intra-abdominal or womb sounds during pregnancy with electronic stethoscopes and build a womb sound library to assess sound trends with gestational development. We also compared these sounds to popular commercial womb sounds marketed to new parents.Study designIntra-abdominal sounds from 50 mothers in their second and third trimester (13 to 40 weeks) of pregnancy were recorded for 6 minutes in a quiet clinic room with 4 electronic stethoscopes, placed in the right upper and lower quadrants, and left upper and lower quadrants of the abdomen. These recording were partitioned into 2-minute intervals in three different positions: standing, sitting and lying supine. Maternal and gestational age, Body Mass Index (BMI) and time since last meal were collected during recordings. Recordings were analyzed using long-term average spectral and waveform analysis, and compared to sounds from non-pregnant abdomens and commercially-marketed womb sounds selected for their availability, popularity, and claims they mimic the intrauterine environment.ResultsMaternal sounds shared certain common characteristics, but varied with gestational age. With fetal development, the maternal abdomen filtered high (500-5,000 Hz) and mid-frequency (100-500 Hz) energy bands, but no change appeared in contributions from low-frequency signals (10-100 Hz) with gestational age. Variation appeared between mothers, suggesting a resonant chamber role for intra-abdominal space. Compared to commercially-marketed sounds, womb signals were dominated by bowel sounds, were of lower frequency, and showed more variation in intensity.ConclusionsHigh-fidelity intra-abdominal or womb sounds during pregnancy can be recorded non-invasively. Recordings vary with gestational age, and show a predominance of low frequency noise and bowel sounds which are distinct from popular commercial products. Such recordings may be utilized to determine whether sounds influence preterm infant development in the NICU.

AIM:To investigate growth patterns and anthropometrics in former extremely low birth weight (ELBW, 0.67 SDS. At 11 years, anthropometrics, neurocognitive performance, body composition, grip strength and puberty scores were assessed. RESULTS:ELBW neonates displayed extra-uterine growth restriction with mean Z-scores for height, weight and head circumference of -0.77, -0.93 and -0.46 at birth, -1.61, -1.67 and -0.72 at 9 months, -1.22, -1.61 and -0.84 at 24 months, and -0.42, -0.49 and -1.09 at 11 years. ELBW children performed consistently worse on neurocognitive testing with an average intelligence quotient equivalent at 11 years of 92.5 (SD 13.1). Catch-up growth was not associated with neurocognitive performance. Compared to controls, ELBW cases had lower grip strength (13.6 vs. 15.9 kg) and percentage lean body weight (75.1 vs. 80.5%), but higher body fat (24.6 vs. 19.2%) and advanced puberty scores at 11 years (all P≤0.025). Catch-up growth for weight and height in the first two years of life in cases was associated with a lower percentage body fat compared to cases without catch-up growth (16.8% catch-up growth for weight vs. 25.7%, P