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BackgroundWhile early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care.ObjectivesFirst, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa.MethodsThis is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants.ResultsParticipant enrolment started in April 2023. Estimated primary completion date is March 2027.ConclusionThe ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators.Trial registrationNCT05551728 in Clinical Trial Registry (https://clinicaltrials.gov).

BACKGROUND: While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care. OBJECTIVES: First, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa. METHODS: This is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants. RESULTS: Participant enrolment started in April 2023. Estimated primary completion date is March 2027. CONCLUSION: The ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators. TRIAL REGISTRATION: NCT05551728 in Clinical Trial Registry ( https://clinicaltrials.gov ).

Most autism research has been conducted in high-income countries, with participants typically from White, upper-middle-income families. Given the disparities experienced by autistic individuals living in underserved communities globally, there is a critical need for research to include individuals from culturally, linguistically, socioeconomically, and geographically diverse backgrounds to understand their unique needs. Qualitative research has the potential to describe the "lived experience" of families historically underrepresented in the autism literature. Here we describe the logistical and methodological challenges of conducting focus group discussions with 22 caregivers of young autistic children living in Cape Town, South Africa. Logistical challenges included (1) recruitment, (2) response rate, and (3) resource access. Methodological challenges included (1) participant background and experiences, (2) interpersonal dynamics, and (3) research ethics. We present recommendations based on lessons learned to reduce these challenges and improve rigorous qualitative research practices in similar low-resource contexts.

Abstract Background Despite the high number of children living with neurodevelopmental disabilities in sub–Saharan Africa, access to early intervention is almost non-existent. It is therefore important to develop feasible, scalable early autism intervention that can be integrated into systems of care. While Naturalistic Developmental Behavioural Intervention (NDBI) has emerged as an evidence-based intervention approach, implementation gaps exist globally, and task-sharing approaches may address access gaps. In this South African proof-of-principle pilot study, we set out to answer two questions about a 12-session cascaded task-sharing NDBI—whether the approach could be delivered with fidelity, and whether we could identify signals of change in child and caregiver outcomes. Methods We utilized a single-arm pre-post design. Fidelity (non-specialists, caregivers), caregiver outcomes (stress, sense of competence), and child outcomes (developmental, adaptive) were measured at baseline (T1) and follow-up (T2). Ten caregiver-child dyads and four non-specialists participated. Pre-to-post summary statistics were presented alongside individual trajectories. Non-parametric Wilcoxon signed rank test for paired samples was used to compare group medians between T1 and T2. Results Caregiver implementation fidelity increased in 10/10 participants. Non-specialists demonstrated a significant increase in coaching fidelity (increases in 7/10 dyads). Significant gains were seen on two Griffiths-III subscales (Language/Communication—9/10 improved, Foundations of Learning—10/10 improved) and on the General Developmental Quotient (9/10 improved). Significant gains were also seen on two Vineland Adaptive Behaviour Scales (Third Edition) subscales (Communication—9/10 improved, Socialization—6/10 improved) and in the Adaptive Behaviour Standard Score (9/10 improved). Caregiver sense of competence improved in 7/10 caregivers and caregiver stress in 6/10 caregivers. Conclusions This proof-of-principle pilot study of the first cascaded task-sharing NDBI in Sub-Saharan Africa provided fidelity and intervention outcome data which supported the potential of such approaches in low-resource contexts. Larger studies are needed to expand on the evidence-base and answer questions on intervention effectiveness and implementation outcomes.

BackgroundWhile early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care.ObjectivesFirst, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa.MethodsThis is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants.ResultsParticipant enrolment started in April 2023. Estimated primary completion date is March 2027.ConclusionThe ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators.Trial registrationNCT05551728 in Clinical Trial Registry (https://clinicaltrials.gov).

When COVID-19 disrupted autism spectrum disorder research globally, many clinical trials of behavioral interventions pivoted to telehealth. Telehealth has the potential to increase geographic reach and improve racial/ethnic diversity in research. This matters because most autism spectrum disorder intervention studies have primarily included White, upper-middle-income families from North America and Europe. Participant homogeneity limits our ability to identify what types of intervention works in which context for which populations. Importantly, telehealth needs to "fit" the local context, and in particular, include strategies that factor in the "digital divide." This short report details contextual considerations and pre-implementation pragmatic adaptations in two autism spectrum disorder clinical trials that include Early Start Denver Model--informed caregiver coaching in the United States and South Africa. By comparing and contrasting how implementation context informed the telehealth pivot in these two clinical trials in different hemispheres, we highlight equity considerations for adaption. The pandemic is an opportunity to understand how remote intervention can "fit" diverse contexts, while providing valid scientific results. It is however important that adaptations be documented and feasibility of the adapted approach be tracked. COVID-19-related telehealth adaptations of behavioral interventions could facilitate the development of new strategies with wider global impact.

According to EU guidance SANCO/7525/VI/95 Rev. 10.3, residue data extrapolation from a surrogate major crop to a minor crop can be used for setting maximum residue levels (MRLs) with a reduced number of residue trials and representative selected pesticides. In this work, a QuEChERS method (citrate-buffered version and PSA with MgSO4 clean-up) and LC-ESI-MS/MS for the determination of boscalid, pyraclostrobin, fludioxonil, fluopyram and tebuconazole in persimmon was developed and validated according to EU Commission guidelines and afterwards used for the determination of residues in four field trials. Residue levels at harvest for each pesticide ranged between 0.347 and 0.028 mg/kg. After comparing EFSA residue data on apples, as the surrogate major crop, and conducting a consumer risk assessment, a proposal of residue data extrapolation to set MRLs in persimmons was performed. The results showed that pesticide residues in persimmons at harvest were consistently lower than residues in apples when substances were applied according to the same critical GAP. MRLs were set at 0.5 mg/kg for fludioxonil, 0.6 mg/kg for boscalid, 0.3 mg/kg for tebuconazole, 0.4 mg/kg for fluopyran and 0.3 mg/kg for pyraclostrobin. The ratio of the MRLs for apple/persimmon varied between 2.5 for boscalid and 1.25 for fluopyram, suggesting that residue extrapolation can be feasible, promoting the process of pesticide registration for minor crops and the settlement of MRL.

Most autism research has been conducted in high-income countries, with participants typically from White, upper-middle-income families. Given the disparities experienced by autistic individuals living in underserved communities globally, there is a critical need for research to include individuals from culturally, linguistically, socioeconomically, and geographically diverse backgrounds to understand their unique needs. Qualitative research has the potential to describe the "lived experience" of families historically underrepresented in the autism literature. Here we describe the logistical and methodological challenges of conducting focus group discussions with 22 caregivers of young autistic children living in Cape Town, South Africa. Logistical challenges included (1) recruitment, (2) response rate, and (3) resource access. Methodological challenges included (1) participant background and experiences, (2) interpersonal dynamics, and (3) research ethics. We present recommendations based on lessons learned to reduce these challenges and improve rigorous qualitative research practices in similar low-resource contexts. Most of the autism research to date has been conducted in high-income countries, with children and families typically from White, upper-middle-income backgrounds. However, we know there are significant inequalities that exist which influence how autistic individuals from diverse, underserved communities can access services they need. As many of these individuals have not been included in the majority of autism research to date, there is much we do not know about these individuals' life experiences, which are critically needed to better inform the development and implementation of care for families from historically underrepresented groups. In this article, we describe the research process we took to conduct focus group discussions with 22 caregivers of young autistic children living in Cape Town, South Africa. We specifically describe the lessons we learned in implementing these focus groups and provide recommendations aimed at how to best reduce logistical and methodological challenges moving forward to improve research conducted in similar low-resource contexts. [ABSTRACT FROM AUTHOR]

When COVID-19 disrupted autism spectrum disorder research globally, many clinical trials of behavioral interventions pivoted to telehealth. Telehealth has the potential to increase geographic reach and improve racial/ethnic diversity in research. This matters because most autism spectrum disorder intervention studies have primarily included White, upper-middle-income families from North America and Europe. Participant homogeneity limits our ability to identify what types of intervention works in which context for which populations. Importantly, telehealth needs to "fit" the local context, and in particular, include strategies that factor in the "digital divide." This short report details contextual considerations and pre-implementation pragmatic adaptations in two autism spectrum disorder clinical trials that include Early Start Denver Model–informed caregiver coaching in the United States and South Africa. By comparing and contrasting how implementation context informed the telehealth pivot in these two clinical trials in different hemispheres, we highlight equity considerations for adaption. The pandemic is an opportunity to understand how remote intervention can "fit" diverse contexts, while providing valid scientific results. It is however important that adaptations be documented and feasibility of the adapted approach be tracked. COVID-19-related telehealth adaptations of behavioral interventions could facilitate the development of new strategies with wider global impact. COVID-19 caused many autism spectrum disorder caregiver-coaching studies to move to telehealth. Telehealth can increase the diversity of people who take part in research. This matters because most autism spectrum disorder studies have included people who have resources, are White, and live in North America and Europe. When study participants are similar, it is hard to understand which interventions can help different types of people who live in different parts of the world. While telehealth may allow more people to take part in research, it needs to "fit" the local context and consider the "digital divide" because many people around the world have no access to computers and the Internet. This short report describes changes to two research studies that include caregiver coaching based on the Early Start Denver Model in the United States and South Africa. We describe how the local context, including technology and Internet access, guided the telehealth approach. By doing so, we highlight ways to make telehealth available to more people around the world. The pandemic can help us understand how telehealth can "fit" diverse places and support high-quality research. It is important that study changes are tracked and we assess how well the changes work. COVID-19 telehealth changes to caregiver coaching can result in new ways to reach more people around the world. [ABSTRACT FROM AUTHOR]

Background: Malignant hypertension has not disappeared and remains the most severe form of hypertension. More than 100 years after its description, many points remain unanswered. Mechanisms, definitions, and optimal treatment are still controversial. In 2019, we decided to launch a prospective multicentre multidisciplinary cohort in France to try to fill these gaps., Method: This study aimed to describe the baseline characteristics of the first 302 included patients and compared these data to already published cohorts. We included patients with severe hypertension associated with severe hypertensive retinopathy and patients filling the HYP MOD (HYPertension MultiOrgan Damage) definition from a broad range of departments (cardiology, nephrology, neurology intensive care unit, emergency department, internal medicine). We collected clinical, biological, imaging, and target organ damage data at admission, along with social and demographic data. We also recorded diagnostic and therapeutic management, adverse events during hospitalization, and characteristics at discharge., Results: We enrolled 302 patients in 32 months (105/year) among 40 centres and different specialties. They mainly included young men (68%, mean age 48.7 ± 14.5 years). Target organ damage involved the eye in 86.7% of patients, kidney in 58.6%, heart in 50%, brain in 32.8%, and Thrombotic Microangiopathy stigmata in 15.6%. Patients with severe retinopathy shared characteristics similar to those included in the most important cohorts already published. We also reported several additional subgroups of interest: one-third of our patients were less than 40 years old, one-third were of non-European origin, 14.3% were included through the multiorgan damage definition, without fundus severe injuries, 22.8% were treated without the use of IV therapy, 40.9% had normal or low renin level, and almost all patients were not on antihypertensive therapy at the time of the enrolment., Conclusion: These preliminary findings already challenge long-standing dogma, raise numerous questions, and provide a solid basis to address them in ancillary studies of the cohort., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)