Roots for Life Project: Strengthening Mental Health in School Communities

NCT07564635 | Recruiting

• 1 other identifier: ORD842
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Mental Health Literacy

Keywords

Mental Health Literacy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 16 weeks

Secondary Outcomes (7)

• Change in Teachers' Mental Health Literacy

  Baseline and 16 weeks

• Change in Parents/Caregivers' Mental Health Literacy

  Baseline and 16 weeks

• Intervention Feasibility Assessed by Teachers' Retention Rate

  At program completion (up to 16 weeks).

• Intervention Feasibility Assessed by Parents/Caregivers' Retention Rate

  At program completion (up to 16 weeks)

• Teachers' Satisfaction with the Intervention Assessed by Likert Survey

  After sessions 1, 2, 3, 4, 5, and 6 (up to 16 weeks)

Study Arms (2)

Child Mental health Literacy Program

EXPERIMENTAL

School staff and parents/caregivers from four schools will receive mental health literacy training through a multicomponent intervention.

Behavioral: Child Mental Health Literacy Program

Control

NO INTERVENTION

School staff and parents/caregivers from four schools will continue with their usual practices without receiving mental health literacy training.

Interventions

Child Mental Health Literacy Program BEHAVIORAL

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.

Child Mental health Literacy Program

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Valparaiso: lead

Study Sites (3)

Servicio Local de Educación (SLEP) Chiloe

Achao, Chiloe, Chile

RECRUITING

Servicio Local de Educación (SLEP)

Valparaíso, Valparaiso, 2581967, Chile

RECRUITING

Unidad educativa Victoria Torres de Neira

Daule, Daule, Ecuador

RECRUITING

Central Study Contacts

Fanny Leyton

CONTACT

996334590; fanny.leyton@uv.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: May 4, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1); CL (2)