An interventional study of Child Mental Health Literacy Program in Mental Health Literacy, sponsored by Universidad de Valparaiso. Recruiting at 3 sites in 2 countries. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Universidad de Valparaiso · Not applicable, Interventional, and Health services research
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.
Child 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.
The 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.
This 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/guardians, and teachers will participate. Assessments will be conducted before and after the intervention using validated instruments.
The 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.
Primary outcome:
Mental health literacy among parents and teachers (MHL Scale).
Secondary outcomes:
Psychological wellbeing of adults (GHQ-12).
Chronic stress levels in children (cortisol in fingernails).
Adverse childhood experiences (ACE questionnaire).
Implementation indicators (acceptability, satisfaction, barriers, facilitators).
Quantitative 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.
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.
Background and Rationale
Child 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.
Mental 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.
The 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.
Study Design
This 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.
Approximately 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.
Intervention
Teacher Program:
Six 2-hour group sessions (12 hours total).
Interactive and experiential methodology: discussion of cases, videos, role-play, and reflective activities.
Topics include: self-care and networks, child development, anxiety and depression, suicide spectrum, ADHD and behavioral disorders, autism spectrum disorder, and child maltreatment.
Parent/Guardian Program:
Three 90-minute workshops.
Topics: stigma and social support, healthy development, warning signs, and emotional containment.
Conducted in schools using participatory and culturally adapted approaches.
Data Collection and Analysis
Baseline 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.
Expected Impact
This 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:
Improved mental health literacy among parents and teachers.
Early identification and referral of children with emotional or behavioral problems.
Reduced stigma and enhanced school-family collaboration.
Development of a scalable, intersectoral model for child mental health promotion aligned with WHO/PAHO priorities.
Results will inform a future cluster randomized trial and the potential regional expansion of the Roots for Life Project
Children Participants:
Teachers:
Parents/Caregivers:
Exclusion Criteria:
Children Participants:
- Child has sensory problems or physical disabilities that prevent completion of surveys
Teachers:
Parents/Caregivers:
School staff and parents/caregivers from four schools will receive mental health literacy training through a multicomponent intervention.
Behavioral: Child Mental Health Literacy Program
School staff and parents/caregivers from four schools will continue with their usual practices without receiving mental health literacy training.
School staff and parents/caregivers 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/caregivers 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.
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/caregivers and teachers. The SDQ assesses emotional problems, conduct problems, hyperactivity/inattention, 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.
Time frame: Baseline and 16 weeks
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 4/5 points to classify as possible mental disorder. Higher scores indicate greater likelihood of presenting mental health problems.
Time frame: Baseline and 16 weeks
Change in Parents/Caregivers' 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 4/5 points to classify as possible mental disorder. Higher scores indicate greater likelihood of presenting mental health problems.
Time frame: Baseline and 16 weeks
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.
Time frame: Baseline and 16 weeks
Change in Parents/Caregivers' 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.
Time frame: Baseline and 16 weeks
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.
Time frame: At program completion (up to 16 weeks).
Intervention Feasibility Assessed by Parents/Caregivers' 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/caregivers who attend at least one session, and the numerator is the number who attend all three sessions. A higher retention rate indicates better feasibility.
Time frame: At program completion (up to 16 weeks)
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).
Time frame: After sessions 1, 2, 3, 4, 5, and 6 (up to 16 weeks)
Parents/Caregivers' 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).
Time frame: After sessions 1, 2, and 3 (up to 16 weeks)
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/mg). Higher levels indicate greater chronic stress exposure or allostatic overload.
Time frame: Baseline and 16 weeks
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