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Recruiting NCT07564635

Roots for Life Project: Strengthening Mental Health in School Communities

No phase Interventional Mental Health Literacy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Child Mental Health Literacy Program.
Who it may be relevant to
Registry conditions: Mental Health Literacy. Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Chile, Ecuador
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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

Interventions

  • Behavioral Child Mental Health Literacy Program
    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, tota

Primary outcome measures

  • Change in Children's Mental Health Problems Measured by SDQ [Time frame: Baseline and 16 weeks]
  • Change in Teachers' Emotional Well-being [Time frame: Baseline and 16 weeks]
  • Change in Parents/Caregivers' Emotional Well-being [Time frame: Baseline and 16 weeks]
Secondary outcome measures (7)
  • Change in Teachers' Mental Health Literacy [Time frame: Baseline and 16 weeks]
  • Change in Parents/Caregivers' Mental Health Literacy [Time frame: Baseline and 16 weeks]
  • Intervention Feasibility Assessed by Teachers' Retention Rate [Time frame: At program completion (up to 16 weeks).]
  • Intervention Feasibility Assessed by Parents/Caregivers' Retention Rate [Time frame: At program completion (up to 16 weeks)]
  • Teachers' Satisfaction with the Intervention Assessed by Likert Survey [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 [Time frame: After sessions 1, 2, and 3 (up to 16 weeks)]
  • Change in Stress Reactivity Measured by Nail Cortisol [Time frame: Baseline and 16 weeks]

Eligibility criteria

Inclusion criteria

Children Participants:

  • Child is enrolled in 3rd, 4th, or 5th grade of primary school
  • Child is under 12 years of age
  • Child's parent or legal guardian has provided written informed consent
  • Child attends a participating public or subsidized school in Valparaíso, Achao, Curaco de Vélez (Chile), or Daule (Ecuador)

Teachers:

  • Works as a teacher in a participating school
  • Teaches students in first or second cycle of primary education (grades 1-6)
  • Voluntarily agrees to participate in the study

Parents/Caregivers:

  • Is the parent or caregiver of a child under 12 years of age
  • Child is enrolled in 3rd, 4th, or 5th grade of primary school
  • Voluntarily agrees to participate in the study

Exclusion criteria

Children Participants:

\- Child has sensory problems or physical disabilities that prevent completion of surveys

Teachers:

  • Works as educational assistant or in administrative functions only
  • Voluntarily declines to participate in the study

Parents/Caregivers:

  • Child has sensory problems or physical disabilities that prevent completion of surveys
  • Voluntarily declines to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Chile · 2 centers
  • Servicio Local de Educación (SLEP) Chiloe — Achao
  • Servicio Local de Educación (SLEP) — Valparaíso
Ecuador · 1 center
  • Unidad educativa Victoria Torres de Neira — Daule

Identifiers

NCT: NCT07564635 · ORD842

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗