[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universidad de los Andes, Chile\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":255},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,53,81,113,139,173,203,225],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100618643","retrolaminar-analgesia-for-lumbar-surgery-100618643",false,"NCT07334288","Retrolaminar Analgesia for LuMbar Surgery","Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial","REALM","Inclusion Criteria:\n\n* Adult patients aged 18-80 years\n* Scheduled for elective lumbar spine surgery (with instrumentation)\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Willing and able to provide written informed consent\n* Able to use patient-controlled analgesia (PCA) device\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Known allergy to local anesthetics (bupivacaine - levobupivacaine - lidocaine) or any study medication\n* Contraindication to regional anesthesia (infection at injection site, coagulopathy)\n* Chronic opioid use (daily use for \\>3 months prior to surgery)\n* Severe psychiatric disorder that precludes informed consent\n* Emergency surgery\n* Diabetes mellitus with preoperative glucose \\>180 mg\u002Fdl\n* Pregnancy or breastfeeding\n* Body mass index (BMI) \\>40 kg\u002Fm²\n* Reoperation or revision of the same level of previous spinal surgery","ALL","18 Years","80 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.",[28,29,30,31,32],"Postoperative Pain","Lumbar Surgery","Back Pain Lower Back Chronic","Opioid Analgesia","Regional Anaesthesia",[34,35,36,37,38,39],"retrolaminar block","regional anesthesia","lumbar spine surgery","Multimodal analgesia","opioid consumption","Ultrasound-guided nerve block","RECRUITING","2026-04-10",{"date":43,"type":44},"2026-04-13","ACTUAL",{"date":46,"type":44},"2026-03-01",{"date":48,"type":22},"2027-06-01",{"name":50,"class":51},"Universidad de los Andes, Chile","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":18,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":52},"100597855","stratified-care-school-based-intervention-for-adolescent-suicidal-ideation-100597855","NCT07063914","Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation","Acceptability and Feasibility of a Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation in Chile: A Study Protocol","Inclusion Criteria:\n\n* Inclusion Criteria for Educational Institutions\n\n  * Located in Santiago, Chile.\n  * Secondary education level (grades I-IV Medio).\n  * Coeducational schools.\n  * At least two classes per grade level in secondary education.\n  * A minimum of 30 students per class.\n  * Socioeconomic vulnerability level of ≥ 50%, as measured by the School Vulnerability Index (Índice de Vulnerabilidad Escolar - IVE-SINAE), which includes factors such as parental education and total household income.\n\nInclusion Criteria for Students\n\n* Enrolled in grades I, II, or III Medio.\n* Suicidal ideation within the past month, defined as a score ≥ 3 on the Columbia-Suicide Severity Rating Scale (C-SSRS).\n* For the Reframe-IT+ program: mild or moderate depressive symptoms, defined as a PHQ-9 score \\\u003C 20.\n* For the CARIBOU program: severe depressive symptoms, defined as a PHQ-9 score ≥ 20.\n\nExclusion Criteria:\n\n* Exclusion Criteria for Students\n\n  * Participation in a structured suicide prevention program (Reframe-IT+) during 2024.\n  * Severe psychotic symptoms, such as perceptual disturbances or delusional ideas, assessed during the eligibility interview.\n  * Suicide attempt(s) in the past three months, assessed during the eligibility interview.","14 Years",{"count":62,"type":22},60,[25],"Background. Suicidal ideation and depressive symptoms are highly prevalent among adolescents, with suicide representing a leading cause of death in this age group worldwide. School-based indicated prevention programs using cognitive behavioral therapy (CBT) have shown promise in addressing these mental health challenges. The Reframe-IT+ (Chile) and CARIBOU (Canada) programs are CBT-based, individually delivered interventions targeting adolescents at risk of suicide. This study aims to evaluate a culturally adapted stratified-care model using these two interventions, matched to depressive symptom severity.\n\nMethods. This is a quasi-experimental, single-arm study with pre-post assessments and follow-ups at 3, 6, 9, and 12 months. Six secondary schools with high socioeconomic vulnerability in Santiago, Chile, will participate. Students with suicidal ideation and mild\u002Fmoderate depressive symptoms (PHQ-9 \\\u003C 20) will be offered Reframe-IT+, while those with severe symptoms (PHQ-9 ≥ 20) will be offered CARIBOU. Primary outcomes include the acceptability of CARIBOU, feasibility of the stratified-care model, and implementation fidelity. Secondary outcomes include reductions in suicidal ideation, depression, anxiety, hopelessness, and improvements in functioning, quality of life, behavioral activation, emotional regulation, and problem-solving skills.\n\nDiscussion. This protocol addresses the need for scalable, culturally sensitive interventions for adolescent suicide prevention in school settings. By evaluating both the process and early outcomes of a stratified-care approach, this study will generate valuable evidence to inform future large-scale effectiveness trials and policy development in adolescent mental health.",[66],"Suicidal Ideation",[68,69,70,71,72],"suicide","adolescents","depression","schools","prevention","2025-07-29",{"date":75,"type":44},"2025-08-01",{"date":77,"type":44},"2025-06-25",{"date":79,"type":22},"2025-12-31",{"name":50,"class":51},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100593035","acceptability-and-feasibility-of-reframe-itu-for-suicidality-in-university-students-100593035","NCT07001202","Acceptability and Feasibility of Reframe-IT+U for Suicidality in University Students.","Acceptability and Feasibility of a Preventive Indicated Intervention for Suicidality in University Students: Reframe-IT+U","Reframe-IT+U","Inclusion Criteria:\n\n* Age 18 or older.\n* Undergraduate students at Universidad de los Andes.\n* Able to read and speak Spanish.\n* Mild to moderate suicide risk in the past month, defined as having answered \"Yes\" to items 1, 2, 3, and\u002For 4 on the Columbia Suicide Severity Rating Scale (C-SSRS).\n\nExclusion Criteria:\n\n* Severe suicide risk, defined as having answered \"Yes\" to item 5 (past month) or item 6 (past 3 months) on the Columbia Suicide Severity Rating Scale (C-SSRS).\n* Presence of a severe, untreated psychiatric condition during the past year or history of psychiatric hospitalization in the last two years.\n* Determination by the University Wellness Team that the participant is not in a suitable condition to participate due to a severe psychiatric condition or need for hospitalization.\n* High severity of psychotic symptoms (score equal to or greater than 2 on any of items 13, 14, and\u002For 15 of the Community Assessment of Psychic Experiences - Positive Scale (CAPE, P15)).",true,{"count":91,"type":22},20,[25],"Mental health in university students is a growing concern worldwide. In Chile, previous studies have shown high rates of depressive symptoms, anxiety, and suicidal risk in this population. This study seeks to evaluate the acceptability and feasibility of a Cognitive Behavioral Therapy (CBT)-based intervention for the indicated prevention of suicidality in undergraduate students, and also to explore its impact on reducing suicidal ideation. A quasi-experimental before-and-after design will be used with a sample of students from the Universidad de los Andes who present mild to moderate suicidal risk. As this is a pilot study, a sample size calculation is not required, but we expect to recruit 20 subjects, which will allow us to conduct acceptability and feasibility assessments and collect data for a larger-scale study. A follow-up will consist of repeating the initial assessment questionnaire, which will be completed two and four months after the intervention. The methodology includes an initial interview to assess inclusion and exclusion criteria, signing informed consent, and developing a safety plan with the students. Following this, six weekly sessions (three in-person and three with digital components) of 60 minutes each will be held, focusing on emotional regulation, cognitive restructuring, and problem-solving. The intervention will be facilitated by trained psychologists, under the supervision of a trained psychologist or psychiatrist. To assess acceptability, the Client Satisfaction Questionnaire (CSQ-8) will be primarily used.\n\nTo assess outcomes, validated instruments will be applied, such as the Columbia Suicide Risk Scale (C-SSRS), the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms, the Generalized Anxiety Disorder 7 (GAD-7) for anxiety symptoms, the Short Form-12 Health Survey (SF-12) for quality of life, the Distress Tolerance Scale (DTS) for stress tolerance, the Community Assessment of Psychic Experiences-Positive (CAPE-P15) for psychotic symptoms, the Difficulties in Emotion Regulation Scale (DERS-E) for emotional regulation, the Social Problem-Solving Inventory-Revised (SPSI-R) for problem-solving, and the Cognitive-behavioural Therapy Skills Questionnaire (CBTSQ) for cognitive-behavioral skills. Reduction in suicidal ideation, satisfaction with the intervention, and program adherence will be measured.\n\nThe study hopes that the prevention program, along with the proposed assessments and procedures, will be appropriate and feasible in a university setting. This will allow progress toward a larger randomized controlled trial. Furthermore, it is expected that students in the intervention group will experience a reduction in suicidal ideation.",[66,95,96],"Depression Disorders","Anxiety",[98,99,100,101,102,103],"Suicidal ideation prevention","Indicated prevention","Depression prevention","Anxiety prevention","University students","College students","NOT_YET_RECRUITING","2025-05-23",{"date":107,"type":44},"2025-06-03",{"date":109,"type":22},"2025-06-01",{"date":111,"type":22},"2025-10-31",{"name":50,"class":51},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":52},"100574327","acceptability-and-feasibility-of-an-in-person-8-week-mindfulness-based-cognitive-therapy-program-among-undergraduates-100574327","NCT06757842","Acceptability and Feasibility of an In-person 8-week Mindfulness-Based Cognitive Therapy Program Among Undergraduates","Acceptability and Feasibility of an 8-week In-person Mindfulness-Based Cognitive Therapy Program in a University Population: a Quasi-experimental Pilot Study","MFS","Inclusion Criteria:\n\n* Undergraduate students at the Universidad de los Andes.\n* Aged 18 or older.\n* Capable of reading and speaking Spanish.\n* With a score on the PHQ-9 depression scale between 0 and 14.\n* Have participated in an informational meeting about the study and the implications of the intervention.\n* Availability to attend 1 weekly session of 90 minutes for 8 consecutive weeks, and time to practice mindfulness exercises at home for at least 15 minutes daily during the intervention period.\n\nExclusion Criteria:\n\n* With a PHQ-9 score greater than or equal to 15.\n* With active suicidality, defined as score ≥ 3 in Columbia suicide severity scale.\n* Currently undergoing psychiatric treatment for a severe condition, understood as: psychotic disorders and\u002For substance abuse.\n* History of hospitalization for psychiatric conditions in the last 2 years.\n* History of having participated in a previous MBI course, such as: MBCT, MBSR, MMB, among others.\n* History of sexual abuse in their lifetime.","30 Years",{"count":123,"type":22},45,[25],"Mental health among university students has emerged as a significant global issue. Recent meta-analyses reveal that 25% of students experience depressive symptoms and 14% exhibit suicidal behaviors. A study involving 19 universities across 8 countries found that 31.4% reported psychiatric disorders in the past year, particularly major depressive episodes and anxiety disorders.\n\nIn Chile, research on university mental health is limited. A 2014 study at Universidad Austral reported a 27% prevalence of depression and a 5.3% risk of moderate to severe suicide risk. The \"First National Survey of University Mental Health\" in 2019 revealed that 46% of students had depressive symptoms, while health surveys from Universidad de los Andes in 2020 and 2022 showed a decrease in these symptoms, although suicide risk remained high.\n\nGiven this situation, preventive interventions are urgently needed. \"Mindfulness-Based Interventions\" (MBIs) have shown effectiveness in university settings. Mindfulness, defined by Jon Kabat-Zinn, involves deliberate, non-judgmental attention to the present moment. Programs like \"Mindfulness-Based Stress Reduction\" (MBSR) have proven effective in reducing symptoms of depression, anxiety, and stress. Studies indicate that MBIs can effectively alleviate mental health symptoms in university populations.\n\nSome of the MBIs include \"Mindful Mood Balance\" (MMB) and \"Mindfulness Skills for Students\". The latter has shown effectiveness in reducing depressive and anxious symptoms among university students.\n\nA 2021 pilot study at Universidad de los Andes on an online 8-session intervention combining mindfulness with cognitive-behavioral techniques yielded positive results in reducing symptoms and enhancing students' quality of life.\n\nIn the current proposal we want to evaluate the feasibility and acceptability of the \"Mindfulness Skills for Students\" program delivered in-person by two trained facilitators. Additionally, we want to explore the efficacy of this intervention in reducing depressive, anxious, and stress symptoms among undergraduate students at Universidad de los Andes, using a quasi-experimental study design.",[127],"Depression\u002FAnxiety",[129,96,130,131],"Depression","Undergraduates","Mindfulness",{"date":133,"type":44},"2025-05-30",{"date":135,"type":44},"2024-10-01",{"date":137,"type":22},"2026-03-31",{"name":50,"class":51},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":157,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":52},"100569432","efficacy-of-the-entire-papilla-preservation-technique-with-and-without-the-use-of-l-prf-as-a-regenerative-material-for-the-treatment-of-infrabony-defects-100569432","NCT06694168","Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects","Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients diagnosed with periodontal disease (loss of interproximal clinical attachment loss in 2 non-adjacent teeth or clinical attachment loss of ≥3mm associated with a PD \\>3 mm in two or more teeth) will be included.\n* After re-evaluation (6 weeks after non-surgical periodontal therapy) presented residual probing depths equal to or greater than 6 mm.\n* Residual pocket is associated with interproximal intrabony periodontal defects of at least 2 walls, with a depth ≥ 3 mm and an angulation ≤ 40º determined on a periapical radiograph.\n\nExclusion Criteria:\n\n* Patients with an underlying decompensated pathology such as diabetes and hypertension.\n* Patients taking medications that interfere with the healing process such as bisphosphonates.\n* Patients with diseases that alter bone metabolism such as osteoporosis.\n* Pregnant or breastfeeding women.",{"count":147,"type":22},30,[25],"The goal of this clinical trial is to evaluate the efficacy of using L-PRF (leukocyte and platelet rich fibrin clot) as an autologous filling material in conjunction with the EPP (entire papilla preservation) technique for the treatment of interproximal intraosseous periodontal defects, compared to the same technique without L-PRF regarding clinical periodontal parameters and obtained radiographic parameters. It will also report possible postoperative complications and evaluate postoperative sensitivity. The main questions it aims to answer is:\n\n• What is the effectiveness of LPR-F in conjunction with a complete papilla preservation (EPP) technique for the treatment of intrabony periodontal defects in CESA (health care center) patients in terms of clinical and radiographic periodontal parameters compared to the use of the same technique without L-PRF?\n\nA non-randomized controlled clinical trial will be conducted on patients at CESA of the Universidad de los Andes. In 30 patients, 30 periodontal defects associated with a pocket with probing depths equal to or greater than 6 mm will be treated using the complete papilla preservation technique, either with L-PRF filling or without any filling material, assigned randomly to each intervention (15 participants in each group). Researchers will evaluate clinical and radiographic parameters at baseline and 6 months post-surgery. Patients will report their level of pain 24 hours and 7 days after surgery.",[151,152,153,154,155,156],"Periodontal Regeneration","Minimally Invasive Surgical Technique","Platelet Rich Fibrin","Microsurgery","Periodontal Intrabony Defect","Periodontal Disease",[158,159,154,160,161,162,163,164],"Periodontitis","Guided Tissue Regeneration","Bone Regeneration","Treatment Outcome","Intrabony defect","minimally invasive surgical technique","Entire papilla preservation","2024-11-20",{"date":167,"type":44},"2024-11-25",{"date":169,"type":44},"2024-08-27",{"date":171,"type":22},"2026-06-30",{"name":50,"class":51},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":181,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":52},"100559731","extra-virgin-olive-oil-supplementation-in-pregnancies-with-increased-cholesterol-levels-100559731","NCT06567951","Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels","Maternal Supraphysiological Hypercholesterolemia: Extra Virgin Olive Oil as a Nutritional Intervention During Pregnancy to Reduce the Impact of This Maternal Condition","MaterLIP","Inclusion Criteria:\n\n* Pregnant women at 26-28 weeks of gestation\n* Singleton pregnancies\n* Pregnancies without fetal malformations\n\nExclusion Criteria:\n\n* Pregnant women with pre-gestational and\u002For gestational diabetes mellitus\n* Pregnant women with obesity before or during pregnancy\n* Pregnant women with pre-eclampsia,\n* Pregnant women with pregnancy hypertensive syndrome\n* Pregnant women with fetal growth retardation","FEMALE",{"count":183,"type":22},120,[25],"The objective of this clinical trial is to know if supplementation with extra virgin olive oil (EVOO) during pregnancy, improves the maternal and neonatal lipoprotein profile, lipoprotein function, oxidative status and vascular dysfunction markers in pregnancies with maternal supraphysiological hypercholesterolemia (MSPH).\n\nThe main questions to be answered are:\n\n1. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH women at the end of pregnancy?\n2. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH neonates at the end of pregnancy? The investigators will compare regular diet supplemented with EVOO vs. intake of a non-supplemented regular diet to determine if EVOO reduces impaired vascular and lipid outcomes in the mother and her newborn.\n\nParticipants:\n\nThe recruited pregnant women will eat their normal diet (control group) or the same diet supplemented with 36 mL of EVOO daily (EVOO group). The protocol will be carried out from gestational week 28 to the end of pregnancy.\n\nA nutritional specialist will evaluate every 4 weeks the EVOO consumption through surveys developed through a zoom interview.\n\nThe recruited pregnant women will have the regular obstetric control every 4 weeks.\n\nAt delivery, a maternal sample of blood as well as umbilical cord blood and the placenta will be obtained for experimental analysis.",[187,188],"Pregnancy Related","Hypercholesterolemia",[190,191,192,193,194],"Pregnancy","Cholesterol","Vascular function","Lipoprotein function","Extra virgin olive oil","2024-08-22",{"date":197,"type":44},"2024-08-23",{"date":199,"type":22},"2024-09-10",{"date":201,"type":22},"2025-09-01",{"name":50,"class":51},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":4},"100555696","experimental-evaluation-of-a-program-to-foster-socioemotional-competence-of-children-in-third-grade-and-their-teachers-100555696","NCT06515444","Experimental Evaluation of a Program to Foster Socioemotional Competence of Children in Third Grade and Their Teachers","10-minutes Project: Experimental Evaluation of the 10-minute Program to Foster Socioemotional Competence of Children in Third Grade and Their Teachers","Inclusion Criteria:\n\n* . The inclusion criteria for schools: at least one third and one fourth grade class.\n\nExclusion Criteria:\n\n* The exclusion criteria for schools are as follows: schools implementing a similar intervention in grades 3 and 4, and special needs schools.",{"count":211,"type":22},750,[25],"The 10-minutes project is an experimental study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes.\n\nThe program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. The activities do not require prior knowledge of teachers on SEL development, nor planning or material preparation.\n\nThe 10-minute project is a quantitative study developed to evaluate whether the 10-minute curriculum and an expanded version with professional development activities for teachers or counselors, 10-minute plus, at third grade would improve students and teachers' socioemotional competence. The randomized control trail involves 30 schools in Chile, matched on socioeconomic measures, size, and urban\u002Frural conditions, assigned randomly to 1 of 3 conditions. Ten schools will receive 10-minutes only, the SEL curriculum taught by teachers or school counselors, during the 2024 and 2025 school years. Ten schools will receive 10-minutes plus during the 2024 school year. Ten schools will serve as \"delayed program\" control, which will have the opportunity to receive the program (10-minutes plus) after the final follow-up. To examine the possibility of fade-out of the effects of the SEL intervention on students, the first experimental condition (10-minutes only) will be randomly divided into two groups, one will receive the intervention for one year only, whereas the second one will receive the intervention for two consecutive years.\n\nIt is expected the program will yield positive effects on the experimental groups (both students and teachers), and effects are expected to be greater in the group offered the 10-minutes plus intervention which entails both a curriculum for children and professional development for teachers, than the effects in the group offered the 10-minutes curriculum exclusively. If the program proves to be effective, then cost-benefit analyses will follow to assess the efficiency of the program. The estimated benefits of the program are expected to be lower than the costs.",[215,216],"Social Skills","Emotion Regulation","2024-07-17",{"date":219,"type":44},"2024-07-23",{"date":221,"type":22},"2024-07-22",{"date":223,"type":22},"2026-12-20",{"name":50,"class":51},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":89,"sex":17,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100548403","japi-cognitive-emotional-and-social-stimulation-for-preschool-children-100548403","NCT06420544","Japi: Cognitive, Emotional and Social Stimulation for Preschool Children","Japi","For schools:\n\nInclusion criteria:\n\n1. Schools located in Santiago (Chile).\n2. Schools with Preschool Education.\n3. Mixed-sex schools.\n4. Schools with vulnerability (≥75%), measured with the School Vulnerability Index - National System of Equality Allocation (IVE-SINAE). This index is the proportion of students in a given school with high vulnerability. This index considers the following socioeconomic variables to group the schools: mother's educational level, father's educational level, and total monthly household income, among others.\n\nExclusion criteria:\n\n1. Three or more classes in Preschool. This criterion was considered for economic and practical reasons.\n2. Implementing a manualized program to promote cognitive or social-emotional skills.\n3. Participating in a similar study.\n\nFor students:\n\nInclusion criteria:\n\n1\\) Children attending pre-kindergarten\n\nExclusion criteria:\n\n1. Children with intellectual disability\n2. Children unable to understand and speak Spanish","3 Years","5 Years",{"count":183,"type":22},[25],"Mental health disorders are one of the leading causes of illness globally, and their relevance is expected to increase. Low and Middle Income Countries (LMIC), already facing psychological and behavioral issues due to chronic adversity, were further impacted during the COVID-19 pandemic. A study showed that symptoms of depression and anxiety in youth doubled during the first year of the pandemic compared to the pre-pandemic period.\n\nA study in China found that the prevalence of the total difficulties was (8.2%), with conduct problems (7.0%), peer problems (6.6%), and hyperactivity-inattention (6.3%) among the most prevalent. In this study emotional problems reached 4.7%. Finally, recent evidence has revealed that students' psychosocial and behavioral problems have increased in the early stage of schools reopened. Several international agencies have calls on governments, and public and private sector partners, to commit, communicate and act to promote mental health for all children, protect those in need of help, and care for the most vulnerable.\n\nThe importance of psychosocial skills acquired in early childhood, such as emotional regulation and social problem-solving, for preventing mental disorders was highlighted. Studies indicate that the development of executive functions and non-cognitive skills in early childhood has a positive impact on long-term health and economic productivity.\n\nHowever, the treatment gap for mental disorders in LMIC is significant, with only one in ten affected receiving treatment. Preventive interventions are needed, particularly in early childhood, to improve cognitive and socio-emotional skills.\n\nObjective: The research proposal aims to develop a gaming platform aiming to improve cognitive and non-cognitive skills in early childhood at schools with high socio-economic vulnerability, supported by Early Years Educators and Parents using a dashboard integrated in a whole system housed in local server, and to evaluate the acceptability and feasibility of this gaming platform and dashboards, with the ultimate goal of reducing behavioral problems, and improving functional and performance outcomes later in life.\n\nOutcomes: Acceptability; Feasibility; Cognitive and non-cognitive skills; Working Memory; Inhibitory control; Emotion recognition; Social competence; Behavioral problems and psychological assessment.",[238],"Behavioral Problem of Child",[240,241,242,243,244,245],"Executive Functions","Behavioral Problem","Children","Videogame","Non-cognitive skills","Cognitive skills","2024-06-12",{"date":248,"type":44},"2024-06-14",{"date":250,"type":44},"2024-06-01",{"date":252,"type":22},"2024-12-31",{"name":50,"class":51},2,""]