Psychoeducation

The research activities of phase 1 and 2 will include purposively recruiting participants for focus group discussion and in-depth interviews. The implementation team will help us identify the key stakeholders in the communities. While the consent form for key stakeholder will be used for all other participants of phase 1 and 2, the consent for phase 1, 2 and 3 for young adults will be covered under 1) consent for parents, if age of participants in intervention is less than 18 and 2) participant consent if they are above 18. Phase 3 of research will follow different process. Phase 3 for children to participate in the study, who are of age less than 18, the parents will be contacted for consent, first a set of screening questions will be asked to determine the eligibility of the participant for the study, once found eligible, a baseline interview will be conducted for collecting non-identifiable socio-demographic, data of the family. The informed consent is sought at this point. The participant will undergo the interviews for the validated questionnaires at 3 time points. Once before the intervention starts, once after 12 months of intervention and once after 18 months of intervention. The consent form for parents to seek permission for participation of the these participants covers all the three phases of the study. Screening and recruitment process: The screening will be a verbal process where the participants will be assessed whether they are eligible for participation. The baseline interview to collect data of the non-identifiable socio-demographic data. The data points to be collected are; 1) details about the land ownership, 2)cattle ownership, 3) type of house, 4) nature of family income, 5) source of water, 6)electricity, 7) material possessions at 'your' (participant's) home (TV, two-wheeler, mobile phone).These details will be used for understanding the socio-economic differences among the participants. Those who qualify to take part in this research study will attend two or more, one and half hour sessions every week, for the duration of one year. They will be assigned a code (name/village/household information will not appear in any document) and placed in one of the 'One-all' groups. Each of the 'One-all' groups will have approximately 20 participants (which will undergo organized sessions and ultimate frisbee game for the duration of the study). The following questionnaires will be administered to the participants as part of evaluation: 1. Connor-Davidson resilience scale (CD- RISC) to measure participant's capacity to bounce back from adversities. 2. The Child Youth Resilience Measure (CYRM) - to measure participant's capacity to bounce back from adversities. 3. GHQ12, a validated measure of participant's mental well-being. 4. Schwarzer's General Self-Efficacy Scale (GSE), to measure participant's self-efficacy. Questionnaires 1-4 will be administered at 3 time points: First time point is the baseline (before the first One-all session); second time point will be at the end of 12 months of receiving one-all sessions and third time point will be after 18 months of receiving One-all sessions as Endline.The participant will undergo intervention provided by the One-all implementation team. Implementation team will visit the communities for enrolling the participants for the intervention. This team will pass on the list of participants who have enrolled for the intervention to the research team. One-all programme delivery by implementation team (separate from research) The three-year curriculum is structured as a series of chapters followed by a year-end event usually a workshop or a tournament. Each chapter begins with an introduction that outlines the major content of the chapter, with topics and their objectives. Lesson plans have been created by the One All curriculum development team for each of these topics. Each session is designed to take maximum of one and half hours. The suggested time is considered the components. However, the lessons can always be expanded on a given day, or spread out over one or more days, for deeper and more graduated learning as time permits. Each session has the following 4 parts: 1. Warm up: provides the opportunity to prepare the children to become familiar with the learning topic for the day through a fun activity that is related to the topic. 2. Drills: are sporting activities that are more physically involved, but also connected to the application of the learning topic. 3. Game: is a mixed-gender "ultimate frisbee" match with modified rules to emphasize the application of the learning topic. 4. Spirit circle: Group discussion that is used to reflect and share the learning of the day. It also guides children in making thoughtful connections that anchor the learning. The implementation team will keep the records pertaining to attendance and the reflections of the sessions in detail. The research team will use these records. No medical records will be accessed through the course of the study.

The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV testing rates among patients presenting with HIV indicator conditions across ten European countries. Study Design: The study employs a stepped-wedge design, whereby clusters of hospitals transition sequentially from a control phase (routine care) to an intervention phase. All patient data are collected retrospectively from routine care, while prospective data are gathered at the healthcare professional level. The project spans four years and involves hospitals from the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. This design allows for comparison of HIV testing rates and related outcomes before and after the implementation across different settings and time points. Intervention: The core intervention involves the establishment of hospital-based HIV teams. Each team is led by an HIV specialist and supported by nurses and data collectors. Their responsibilities include: Identification and Surveillance: Screening routine electronic health records for HIV indicator conditions using predefined ICD-10 codes and verifying cases that warrant HIV testing. Audit \& Feedback: Providing targeted recommendations to treating physicians when an HIV test is indicated but has not been performed, thereby prompting action. Education \& Training: Delivering training sessions to healthcare professionals to improve their knowledge and attitudes towards HIV testing, prevention, and care. Enabling Environment: Implementing digital solutions and other support mechanisms to streamline testing processes, reduce stigma, and enhance overall guideline adherence. Linkage to prevention: Improving linkage to the locally available preventive services. The intervention is intended to integrate seamlessly into routine hospital care, thereby reinforcing existing guidelines while addressing the current diagnostic testing gap. Endpoints and Outcome Measures: Primary Endpoint: The change in HIV testing rate among patients diagnosed with HIV indicator conditions before and after the implementation of HIV teams. Key Secondary Endpoints: The change in the incidence of new HIV diagnoses among patients with HIV indicator conditions. Variations in HIV testing rates across different countries, medical specialties, and types of indicator conditions, as well as over time. Assessment of the cascade of HIV diagnosis, including the proportion of patients identified with an indicator condition, the offer and acceptance of HIV testing, and documented reasons for non-testing. Evaluation of the cascade of HIV care and prevention, including linkage to HIV care, achievement of viral suppression, and referral and uptake of preventive services. Changes in healthcare professionals' knowledge, attitudes, and levels of stigma towards HIV. Implementation outcomes such as fidelity of HIV team activities, resource utilization, cost-effectiveness, and sustainability of the intervention. Analysis of contextual factors, barriers, and facilitators impacting the implementation process, using established frameworks like CFIR and RE-AIM. Impact: By introducing HIV teams and systematically monitoring their effect on HIV testing practices, the study aims to enhance early HIV diagnosis and improve patient outcomes. The findings will contribute to evidence-based guidelines and may promote the adoption of similar interventions across European healthcare settings, ultimately reducing HIV-associated morbidity, mortality, and transmission rates. This project not only addresses a critical diagnostic gap in HIV care but also provides valuable insights into the effective implementation of complex interventions in routine clinical practice.

The goal of this intervention study is to learn if the intervention can increase positive health and health literacy in people with limited health literacy. The main questions it aims to answer are: * Does participating in the intervention 'Gezond en goed met elkaar' increase participant's positive health? * Does participating in the intervention 'Gezond en goed met elkaar' improve health literacy? Researchers will compare people who participate in the intervention with people who haven't participated in the intervention yet. Participants will: * participate in the intervention (3 months) * fill out questionnaires every 3 months

Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.

The Shining Star study is a randomized controlled trial designed to evaluate the feasibility and preliminary effectiveness of a 12-week home-based mHealth intervention aimed at improving adherence to the 24-Hour Movement Guidelines (physical activity, sedentary behavior, and sleep) among preschool-aged children (3-4 years old). The trial consists of two groups: an intervention group receiving the mHealth intervention and a waitlist control group. The primary objective is to determine if the intervention increases the proportion of children meeting all three 24-Hour Movement Guidelines. The intervention focuses on engaging parents through a mobile app, which delivers weekly lessons and behavior-related goals to promote healthy movement behaviors in children. Secondary objectives include assessing changes in child motor skills, cognition, behavioral problems and executive function, and BMI. Study Design and Procedures: Participants will be randomly assigned to either the intervention group or a waitlist control group. The intervention group will use the Shining Star mobile app, which provides short, weekly messages (less than 500 characters) and links to additional resources. The app will also include gamification elements, behavior trackers, and a forum for parents to connect with each other. Participants in the control group will receive access to the app after the 12-week intervention period. Key measurements will be taken at three time points: baseline (Week 0), mid-point (Week 6), and at the end of the intervention (Week 12). Measurements include accelerometer data to assess physical activity, sedentary time, and sleep, anthropometrics to assess BMI, as well as parent-reported screen time, child motor skills, behavioral problems and executive function, and cognition. Usability and feasibility of the mobile app will be assessed through weekly app usage and feedback questionnaires. Sample Size and Statistical Plan: A total of 80 parent-child dyads (40 per group) will be enrolled in the study. A sample size of 30 families per group is expected to provide 80% power to detect a meaningful difference in the proportion of children meeting all three recommendations after 12 weeks. Based on a projected dropout rate of 25%, the target enrollment is 80 families. Statistical analysis will focus on two primary hypotheses: 1. Whether a greater proportion of children in the intervention group meet the 24-Hour Movement Guidelines compared to the control group at 12 weeks. 2. Whether parents report that the intervention is feasible, with a target feasibility rating of ≥4.0/5.0 on a Likert scale. Additional exploratory analyses will evaluate changes in child motor skills, behavioral problems, cognition, and growth as well as home-level and parent-level correlates. Quality Assurance and Data Management: Data will be collected using validated measures, and all data will be securely stored in REDCap. Clinical data collected at screening and follow-up visits, including accelerometer data and questionnaires, will be stored in a secure database at the University of Kansas Medical Center (KUMC). The data will undergo validation and consistency checks before analysis. * Quality Assurance Plan: The research coordinator will ensure that accurate and complete data is transcribed from paper sources into REDCap. To maintain data quality, accuracy, and integrity, data entry will be performed twice. The REDCap data comparison tool will then be used to produce a final \"Clean\" entry. * Missing Data Plan: Participants who do not complete the required assessments at baseline (Week 0), mid-point (Week 6), and end of the intervention (Week 12) will be excluded from the final analysis. Efforts will be made to retain participants throughout the study to minimize missing data. * Statistical Analysis Plan: The primary analysis will compare the proportion of participants in the intervention and control groups meeting all three recommendations at 12 weeks using chi-square analysis. The secondary analysis will average the Likert scale responses across all weeks completed. Exploratory analyses will utilize linear regression to examine changes in outcomes between the treatment and control groups, along with iso-temporal substitution analysis to assess the impact of behavior substitution on child developmental outcomes. Additionally, the investigators will examine the relationship between meeting specific movement recommendations and child outcomes, with changes in theoretical components as potential mediators. Statistical significance will be set at p = 0.05 for analyses. The study will also adhere to KUMC standard operating procedures for data collection, data analysis, and confidentiality as outlined in the study protocol.

The GEROS Project aims to develop and implement a Service-Learning (S-L) program that integrates Comprehensive Geriatric Assessment (CGA) and health promotion, for students at the Faculty of Health Sciences and Welfare at the University of Vic - Central University of Catalonia (UVic-UCC). This initiative engages university students, healthcare professionals, and older adults (60+) in a participatory, intergenerational approach that fosters mutual learning and community engagement. The study follows a non-experimental mixed-method design, involving students from Nursing, Physiotherapy, Human Nutrition and Dietetics, Occupational Therapy, and Psychology. Participants include older adults (60+) who can independently travel to the university. The project is integrated into different subjects, in groups of 4-5 students, participants conduct a Comprehensive Geriatric Assessment (CGA), evaluating frailty using VIG-Frail, intrinsic capacity with ICOPE, quality of life with EUROQOL 5D-5L, and specific health indicators with Nursing Outcomes Classification (NOC). To assess the program's effectiveness, several outcome measures will be analyzed including students' perceived knowledge, competencies, and skills, as well as older adults' awareness of their health status, lifestyle, and risk factors. Additionally, the satisfaction levels of both will be evaluated. The items will be evaluated using a 1-5 Likert Scale, and the analysis will be conducted with SPSS. Data recording will be carried out through REDCap. The GEROS Project aligns with the United Nations' Sustainable Development Goals (SDGs), specifically SDG 3 (Good Health and Well-being) and SDG 10 (Reduced Inequalities). By offering care to the aging population and providing them with personalized health recommendations, the project promotes preventive strategies, active aging, and intergenerational learning. Furthermore, GEROS integrates innovative educational methodologies, encouraging experiential learning, collaboration with healthcare professionals, and the development of practical skills in real-world contexts. The program's scalability and adaptability could serve as a model for other universities and healthcare institutions aiming to enhance geriatric care through service-learning initiatives.

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will: * have their blood pressure, heart rate, temperature, height and weight measured * have blood and urine samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) * answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer * answer questions about how they are feeling, or have their parents or guardian's answer * answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.

This quasi-experimental study without a control group will be conducted at the Universidad Nacional de La Matanza (UNLaM), Argentina, between March and July 2025. The study aimed to evaluate the effect of an educational intervention based on active learning strategies on evidence-based practice (EBP) competencies among physiotherapy students. The intervention was implemented as part of a four-month Research Methods course and included weekly group-based activities such as literature retrieval, critical appraisal, oral presentations, peer feedback, and structured assessments using rubrics. The course aimed to strengthen students' beliefs, attitudes, perceived skills, and frequency of use related to EBP. Outcomes were assessed using a custom-developed and validated questionnaire covering four domains and key competencies in EBP. Secondary outcomes included academic engagement, measured with the Utrecht Work Engagement Scale - Student Version (UWES-S), and student satisfaction, assessed through the Student Outcomes Survey. Data collection occurred at baseline, at the end of the course, and one week after completion. The study followed TREND reporting guidelines and was approved by the institutional research ethics committee at UNLaM.

Attention Deficit Hyperactivity Disorder (ADHD) remains a prevalent neurodevelopmental disorder affecting children worldwide, often characterized by persistent patterns of inattention, hyperactivity, and impulsivity that significantly impair daily functioning. While conventional treatments such as stimulant medications and behavioral therapies are commonly prescribed, interest in complementary and alternative approaches, including acupuncture, has grown. This study proposes a rigorous examination of acupuncture's potential efficacy as a treatment modality for ADHD, employing a mixed-methods approach to triangulate acupoint data mining, treatment outcomes assessment, and patient perspectives. The primary objective is to evaluate the therapeutic effects of acupuncture in children aged 6-12 years diagnosed with ADHD. The research design involves a prospective cohort study wherein participants will be allocated to receive either acupuncture combined with traditional Chinese herbal treatment or herbal treatment alone. Quantitative assessment of ADHD symptom and related impairment administered at baseline, post-treatment, and follow-up intervals. Additionally, qualitative interviews with participants, their caregivers and clinicians will explore subjective experiences, treatment satisfaction, and perceived changes in ADHD symptoms. This prospective cohort study will recruit 6-12 year-old children diagnosed with ADHD from pediatrics department of the third affiliated hospital of Beijing University of Chinese Medicine. Participants will be randomly assigned to two groups: an experimental group receiving acupuncture alongside traditional Chinese herbal treatment, and a control group receiving only the herbal treatment. The study will adhere to ethical guidelines, ensuring informed consent from parents and assent from children. The research content includes three parts, as follows Phase I: Acupoint data mining for core acupoints Acupoint data mining will guide personalized treatment protocols, selecting points historically used for ADHD and supported by current research. Phase II: Clinical Trial Intervention Quantitative assessment will involve administering the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL™ 4.0 Generic Core Scales, PSQI and CGI at baseline, post-treatment, and follow-up intervals to measure changes in ADHD symptomatology, executive function, quality of life, and sleep quality. Phase III: Qualitative Interview Qualitative methods will complement quantitative findings, capturing subjective experiences through semi-structured interviews with children, parents, and clinicians. This approach aims to provide a holistic understanding of treatment efficacy, patient satisfaction, and perceived improvements in ADHD symptoms, executive function, quality of life, and sleep patterns. Statistical analyses will compare SNAP-IV, Conners 3-P, BRIEF-2, PSQI and PedsQL™ 4.0 Generic Core Scales scores between groups, supplemented by thematic analysis of qualitative data to explore treatment satisfaction and symptom changes. Statistical analyses, including paired t-tests, ANOVA, and thematic analysis, will be employed to compare outcomes between treatment groups and explore correlations between acupuncture treatment, symptom alleviation, and overall well-being measures.

Mental disorders are among the leading causes of disability and morbidity worldwide-conditions that are compounded by a vast treatment gap where an estimated 70% of people who need mental health care go without adequate or any treatment at all. In Brazil, despite having a comprehensive network of publicly-funded, free, community-based mental health treatment, it is estimated that only 26% of people with psychiatric conditions successfully connect to community-based care. The remaining seek treatment only under emergency or crisis conditions, contributing to overcrowding in emergency departments, long waiting periods for psychiatric beds, psychiatric boarding, poorer overall quality of care, and an overreliance on a hospital system that is already overburdened (and increasingly so due to COronaVIrus Disease of 2019 (COVID-19). This problem has increasingly and disproportionately affected people with a serious mental illness (SMI) who are poor and non-white. Goals of recovery and rebuilding a meaningful life in the community become overshadowed by those of stabilization and symptom management. Contributing factors to this mental health treatment gap are plenty (i.e., stigma and discrimination, workforce shortages, economic disparities, lack of timely follow-up and engagement, discontinuous and fragmented linkages between care settings), yet solutions are scarce. The proposed project uses a participatory research and adaptation design that involves stakeholders, including persons living with SMI, family members, clinicians, community services staff and administrators, throughout all stages of project development and implementation. The study hypotheses include that the successful adaptation and implementation of an evidence-based model of peer support to Brazilian culture, will contribute to enhanced levels of engagement, improved continuity of care, and improvements in quality of life and wellbeing among persons living with SMI in Brazil. To this end, the following specific aims are proposed: 1) To work with local stakeholders in Campinas, Brazil on the cultural adaptation of an evidence-based peer intervention targeting connections with a peer as a mediator of engagement in postacute mental and physical healthcare; 2) To employ an experimental therapeutics approach in determining the degree to which multi-level targets are engaged in the pathway improved outcomes through a pilot clinical trial; 3) To assess the feasibility, acceptability, safety, tolerability, and potential for dissemination of the adapted peer intervention at multiple levels. After this study, it is hypothesized that the feasibility, acceptability, safety and tolerability, of adapting a low-cost, culturally-responsive, evidence-based intervention to improve quality of care of people with SMI who access community mental health treatment will be established. Moreover, through a Yale-University of Campinas partnership, these actions will foster international collaboration as a strategy to develop an innovative technology that would be ready for an implementation and effectiveness trial (R01) in poor communities in Latin countries. Finally, the adaptation strategy developed in this proposal can be used in other Low and Middle Income Countries (LMICs) to adapt evidence-based practices (EBPs).