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Roots for Life Project: Strengthening Mental Health in School Communities

26 aprile 2026 aggiornato da: Universidad de Valparaiso

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

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.

Panoramica dello studio

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Chiloe
      • Achao, Chiloe, Chile
        • Reclutamento
        • Servicio Local de Educación (SLEP) Chiloe
        • Contatto:
    • Valparaiso
      • Valparaíso, Valparaiso, Chile, 2581967
        • Reclutamento
        • Servicio Local de Educación (SLEP)
        • Contatto:
    • Daule
      • Daule, Daule, Ecuador
        • Reclutamento
        • Unidad educativa Victoria Torres de Neira
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Child Mental health Literacy Program
School staff and parents/caregivers from four schools will receive mental health literacy training through a multicomponent intervention.
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.
Nessun intervento: Control
School staff and parents/caregivers from four schools will continue with their usual practices without receiving mental health literacy training.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Children's Mental Health Problems Measured by SDQ
Lasso di tempo: Baseline and 16 weeks
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
Lasso di tempo: Baseline and 16 weeks
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
Lasso di tempo: Baseline and 16 weeks
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Teachers' Mental Health Literacy
Lasso di tempo: Baseline and 16 weeks
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.
Baseline and 16 weeks
Change in Parents/Caregivers' Mental Health Literacy
Lasso di tempo: Baseline and 16 weeks
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.
Baseline and 16 weeks
Intervention Feasibility Assessed by Teachers' Retention Rate
Lasso di tempo: At program completion (up to 16 weeks).
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).
Intervention Feasibility Assessed by Parents/Caregivers' Retention Rate
Lasso di tempo: At program completion (up to 16 weeks)
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.
At program completion (up to 16 weeks)
Teachers' Satisfaction with the Intervention Assessed by Likert Survey
Lasso di tempo: After sessions 1, 2, 3, 4, 5, and 6 (up to 16 weeks)
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)
Parents/Caregivers' Satisfaction with the Intervention Assessed by Likert Survey
Lasso di tempo: After sessions 1, 2, and 3 (up to 16 weeks)
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)
Change in Stress Reactivity Measured by Nail Cortisol
Lasso di tempo: Baseline and 16 weeks
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.
Baseline and 16 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2025

Completamento primario (Stimato)

31 maggio 2026

Completamento dello studio (Stimato)

31 luglio 2026

Date di iscrizione allo studio

Primo inviato

10 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ORD842

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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