[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636357":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":53,"studyPopulation":44,"armGroups":54,"interventions":65,"overallOfficials":44,"centralContacts":71,"locations":78,"responsibleParty":121,"collaborators":44,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":44,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":44,"enrollmentInfo":133,"targetDuration":44,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":81,"whyStopped":44,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Universidad de Valparaiso","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":44},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in Children's Mental Health Problems Measured by SDQ","Change in the Total Difficulties Score (TDS) of the Strengths and Difficulties Questionnaire (SDQ) completed by parents\u002Fcaregivers and teachers. The SDQ assesses emotional problems, conduct problems, hyperactivity\u002Finattention, and peer relationship problems. The Total Difficulties Score is obtained by summing four of the five dimensions (excluding prosocial behavior). Scores range from 0 to 40, with higher scores indicating greater difficulties. Scores from parent and teacher reports will be analyzed.","Baseline and 16 weeks",{"measure":14,"description":15,"timeFrame":12},"Change in Teachers' Emotional Well-being","Change in teachers' mental health problems measured with the 12-item General Health Questionnaire (GHQ-12). The GHQ-12 is a screening instrument for detecting possible mental disorders. It consists of 12 questions. The best cut-off point validated in Chile is between 4\u002F5 points to classify as possible mental disorder. Higher scores indicate greater likelihood of presenting mental health problems.",{"measure":17,"description":18,"timeFrame":12},"Change in Parents\u002FCaregivers' Emotional Well-being","Change in parents and caregivers' mental health problems measured with the 12-item General Health Questionnaire (GHQ-12). The GHQ-12 is a screening instrument for detecting possible mental disorders. It consists of 12 questions. The best cut-off point validated in Chile is between 4\u002F5 points to classify as possible mental disorder. Higher scores indicate greater likelihood of presenting mental health problems.",[20,23,25,29,33,37,41],{"measure":21,"description":22,"timeFrame":12},"Change in Teachers' Mental Health Literacy","Change in mental health literacy level measured with the Mental Health Literacy Scale validated in Chile. This scale assesses knowledge about identification and treatment of mental disorders, help-seeking, and stigma reduction. The scale has 5 sections with 12 items. Higher scores indicate greater level of mental health literacy.",{"measure":24,"description":22,"timeFrame":12},"Change in Parents\u002FCaregivers' Mental Health Literacy",{"measure":26,"description":27,"timeFrame":28},"Intervention Feasibility Assessed by Teachers' Retention Rate","Feasibility will be assessed as the percentage of teachers who complete the mental health literacy program (attendance at all six sessions) among those who initiate the program. The denominator is the number of teachers who attend at least one session, and the numerator is the number who attend all six sessions of the program.","At program completion (up to 16 weeks).",{"measure":30,"description":31,"timeFrame":32},"Intervention Feasibility Assessed by Parents\u002FCaregivers' Retention Rate","Feasibility measured by the percentage of parents and caregivers who complete the mental health literacy program (attend all 3 sessions of 90 minutes) among those who started the program. The denominator is the number of parents\u002Fcaregivers who attend at least one session, and the numerator is the number who attend all three sessions. A higher retention rate indicates better feasibility.","At program completion (up to 16 weeks)",{"measure":34,"description":35,"timeFrame":36},"Teachers' Satisfaction with the Intervention Assessed by Likert Survey","Teachers' satisfaction with each module of the intervention, measured through a study-specific survey with Likert-type questions (scale from 1 to 5) administered after each workshop session. The survey also includes open-ended questions about valued aspects and suggestions for improvement. Higher scores indicate greater satisfaction. Scale: 1 (minimum satisfaction) to 5 (maximum satisfaction).","After sessions 1, 2, 3, 4, 5, and 6 (up to 16 weeks)",{"measure":38,"description":39,"timeFrame":40},"Parents\u002FCaregivers' Satisfaction with the Intervention Assessed by Likert Survey","Parents and caregivers' satisfaction with each module of the intervention, measured through a study-specific survey with Likert-type questions (scale from 1 to 5) administered after each workshop session. The survey also includes open-ended questions about valued aspects and suggestions for improvement. Higher scores indicate greater satisfaction. Scale: 1 (minimum satisfaction) to 5 (maximum satisfaction).","After sessions 1, 2, and 3 (up to 16 weeks)",{"measure":42,"description":43,"timeFrame":12},"Change in Stress Reactivity Measured by Nail Cortisol","Change in accumulated cortisol levels measured in children's nail samples. Nail cortisol reflects chronic stress exposure during the 4-5 months prior to sample collection. Results are expressed in picograms of cortisol per milligram of nail (pg\u002Fmg). Higher levels indicate greater chronic stress exposure or allostatic overload.",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","HEALTH_SERVICES_RESEARCH",{"masking":50,"maskingDescription":44,"whoMasked":51},"SINGLE",[52],"OUTCOMES_ASSESSOR","This pilot study aims to evaluate the preliminary effectiveness and feasibility of a mental health literacy (MHL) intervention directed at teachers and parents in primary schools (grades 3-5) located in socially vulnerable communities in Chile and Ecuador. The ultimate goal is to improve the mental health and wellbeing of children through enhanced recognition, prevention, and response to mental health needs in school and family environments.\n\nBackground and Rationale\n\nChild mental health is a key determinant of overall wellbeing in adulthood. In Latin America, mental disorders among children and adolescents account for a significant disease burden, yet more than 70% of affected children receive no specialized care. Schools are often the first setting where emotional and behavioral problems are detected, but teachers and families frequently lack the necessary knowledge to identify mental health issues or to access appropriate support networks.\n\nMental health literacy-defined as knowledge and beliefs about mental disorders that aid their recognition, management, or prevention-has proven effective in promoting early detection, help-seeking, and stigma reduction. However, most MHL programs have targeted adolescents, with few focused on primary education or on low- and middle-income countries. This project seeks to fill that gap by implementing and adapting an evidence-informed MHL program for educators and parents in both Chile and Ecuador.\n\nThe intervention builds upon the previous FONIS Project SA21I0143, which demonstrated that teacher-focused MHL workshops improved mental health knowledge, reduced depressive symptoms, and lowered burnout.\n\nStudy Design\n\nThis is a quasi-experimental pilot study with intervention and control schools in both countries. The intervention will be implemented in seven primary schools: five in Chile (Valparaíso, Achao, and Curaco de Vélez) and two in Ecuador (Daule). Randomization will occur at the school level within each locality.\n\nApproximately 230 children (ages 8-11 years) and their parents and teachers will participate. Data will be collected pre- and post-intervention, combining quantitative and qualitative methods.\n\nIntervention\n\nTeacher Program:\n\nSix 2-hour group sessions (12 hours total).\n\nInteractive and experiential methodology: discussion of cases, videos, role-play, and reflective activities.\n\nTopics include: self-care and networks, child development, anxiety and depression, suicide spectrum, ADHD and behavioral disorders, autism spectrum disorder, and child maltreatment.\n\nParent\u002FGuardian Program:\n\nThree 90-minute workshops.\n\nTopics: stigma and social support, healthy development, warning signs, and emotional containment.\n\nConducted in schools using participatory and culturally adapted approaches.\n\nData Collection and Analysis\n\nBaseline data will be collected in April 2025, followed by post-intervention assessment in the second semester of 2025. Quantitative data will be analyzed using paired comparisons and effect size estimation (Cohen's d). Mediation and moderation analyses will explore the roles of family, school, and neighborhood factors. Qualitative data from focus groups with parents and teachers will be thematically analyzed to assess feasibility and contextual factors.\n\nExpected Impact\n\nThis pilot will provide foundational evidence on the feasibility, cultural adaptation, and preliminary effectiveness of a community-based MHL program in Latin American primary schools. Expected benefits include:\n\nImproved mental health literacy among parents and teachers.\n\nEarly identification and referral of children with emotional or behavioral problems.\n\nReduced stigma and enhanced school-family collaboration.\n\nDevelopment of a scalable, intersectoral model for child mental health promotion aligned with WHO\u002FPAHO priorities.\n\nResults will inform a future cluster randomized trial and the potential regional expansion of the Roots for Life Project",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"Child Mental health Literacy Program","EXPERIMENTAL","School staff and parents\u002Fcaregivers from four schools will receive mental health literacy training through a multicomponent intervention.",[60],"Behavioral: Child Mental Health Literacy Program",{"label":62,"type":63,"description":64,"interventionNames":44},"Control","NO_INTERVENTION","School staff and parents\u002Fcaregivers from four schools will continue with their usual practices without receiving mental health literacy training.",[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":44},"BEHAVIORAL","Child Mental Health Literacy Program","School staff and parents\u002Fcaregivers from four schools will receive mental health literacy training through a multicomponent intervention. Educators will attend 6 in-person modules (120 minutes each, totaling 12 contact hours) covering care and self-care, healthy development, and mental health problems including anxiety, depression, suicidal spectrum, ADHD, conduct disorders, autism spectrum, and child maltreatment. Parents\u002Fcaregivers will participate in 3 in-person modules (90 minutes each, totaling 4.5 contact hours) addressing stigma, support networks, healthy development, warning signs, and emotional containment. Both components use participatory methodologies including case discussions, audiovisual resources, and group reflection to create a coordinated support network for children's mental health.",[56],[72],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},"Fanny Leyton","CONTACT","996334590","+56","fanny.leyton@uv.cl",[79,94,106],{"facility":80,"status":81,"city":82,"state":83,"zip":44,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Servicio Local de Educación (SLEP) Chiloe","RECRUITING","Achao","Chiloe","Chile","CL",{"type":87,"coordinates":88},"Point",[89,90],-73.49138,-42.47086,{"lat":90,"lon":89},[93],{"name":73,"role":74,"phone":75,"phoneExt":44,"email":77},{"facility":95,"status":81,"city":96,"state":97,"zip":98,"country":84,"countryCode":85,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Servicio Local de Educación (SLEP)","Valparaíso","Valparaiso","2581967",{"type":87,"coordinates":100},[101,102],-71.62963,-33.036,{"lat":102,"lon":101},[105],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},{"facility":107,"status":81,"city":108,"state":108,"zip":44,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Unidad educativa Victoria Torres de Neira","Daule","Ecuador","EC",{"type":87,"coordinates":112},[113,114],-79.97683,-1.86032,{"lat":114,"lon":113},[117],{"name":73,"role":74,"phone":118,"phoneExt":119,"email":120},"986510209","+593","fanny.leyton@gmail.com",{"type":122,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100636357","roots-for-life-project-strengthening-mental-health-in-school-communities-100636357",false,"NCT07564635","Roots for Life Project: Strengthening Mental Health in School Communities","Pilot Study of a Mental Health Literacy-Based Intervention for Parents and Teachers to Improve the Mental Health of Children in 3rd to 5th Grade in Chile and Ecuador","Inclusion Criteria:\n\nChildren Participants:\n\n* Child is enrolled in 3rd, 4th, or 5th grade of primary school\n* Child is under 12 years of age\n* Child's parent or legal guardian has provided written informed consent\n* Child attends a participating public or subsidized school in Valparaíso, Achao, Curaco de Vélez (Chile), or Daule (Ecuador)\n\nTeachers:\n\n* Works as a teacher in a participating school\n* Teaches students in first or second cycle of primary education (grades 1-6)\n* Voluntarily agrees to participate in the study\n\nParents\u002FCaregivers:\n\n* Is the parent or caregiver of a child under 12 years of age\n* Child is enrolled in 3rd, 4th, or 5th grade of primary school\n* Voluntarily agrees to participate in the study\n\nExclusion Criteria:\n\nChildren Participants:\n\n\\- Child has sensory problems or physical disabilities that prevent completion of surveys\n\nTeachers:\n\n* Works as educational assistant or in administrative functions only\n* Voluntarily declines to participate in the study\n\nParents\u002FCaregivers:\n\n* Child has sensory problems or physical disabilities that prevent completion of surveys\n* Voluntarily declines to participate in the study",true,"ALL","5 Years",{"count":134,"type":135},200,"ESTIMATED","INTERVENTIONAL",[138],"NA","This pilot study, titled \"Roots for Life Project: Strengthening Mental Health in School Communities\", aims to evaluate the feasibility and preliminary effectiveness of a mental health literacy (MHL) intervention for teachers and parents to improve the mental health of children aged 8-11 years (3rd to 5th grade) in primary schools located in socially vulnerable areas of Chile and Ecuador.\n\nChild mental health problems represent a major burden worldwide, with high prevalence and a treatment gap exceeding 70% in Latin America. Schools and families play a key role in early detection, yet both often lack the necessary knowledge and confidence to identify mental health difficulties or seek appropriate help. Increasing mental health literacy-defined as knowledge and beliefs that support recognition, management, and prevention of mental health problems-has proven to enhance early help-seeking, reduce stigma, and promote wellbeing.\n\nThe project builds upon the prior Chilean FONIS Project SA21I0143, which tested a teacher-focused MHL program and demonstrated improvements in teachers' knowledge, reduced depressive symptoms, and lower burnout levels. The current study extends this work by (1) adding a parent-focused component, (2) evaluating outcomes in children, and (3) implementing the program in two countries to assess cross-cultural feasibility.\n\nThis quasi-experimental study will include seven primary schools-five in Chile (Valparaíso, Achao, Curaco de Vélez) and two in Ecuador (Daule). Schools will be randomly assigned within each locality to either intervention or control conditions. Approximately 230 children, their parents\u002Fguardians, and teachers will participate. Assessments will be conducted before and after the intervention using validated instruments.\n\nThe teacher program consists of six 2-hour participatory workshops covering topics such as self-care, child development, anxiety and depression, suicide prevention, behavioral disorders, autism, and child maltreatment. The parent program includes three 90-minute educational sessions addressing stigma, social support, healthy development, and emotional containment. Both components emphasize experiential learning and culturally adapted materials.\n\nPrimary outcome:\n\nMental health literacy among parents and teachers (MHL Scale).\n\nSecondary outcomes:\n\nPsychological wellbeing of adults (GHQ-12).\n\nChronic stress levels in children (cortisol in fingernails).\n\nAdverse childhood experiences (ACE questionnaire).\n\nImplementation indicators (acceptability, satisfaction, barriers, facilitators).\n\nQuantitative analyses will compare pre- and post-intervention outcomes and calculate effect sizes. Mediation and moderation models will explore relationships among child, family, and school-level variables. Qualitative data from focus groups with parents and teachers will complement these findings to evaluate feasibility and contextual adaptations.",[141],"Mental Health Literacy",[141],"2026-04-26",{"date":145,"type":146},"2026-05-04","ACTUAL",{"date":148,"type":146},"2025-03-01",{"date":150,"type":135},"2026-07-31",{"name":5,"class":6},3]