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临床试验/NCT07564635
NCT07564635招募中不适用

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

Universidad de Valparaiso3 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
3
主要终点
Change in Children's Mental Health Problems Measured by SDQ

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)
  • 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

排除标准

  • Children Participants:
  • - Child has sensory problems or physical disabilities that prevent completion of surveys
  • 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

研究组 & 干预措施

Child Mental health Literacy Program

Experimental

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

干预措施: Child Mental Health Literacy Program (Behavioral)

Control

No Intervention

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

结局指标

主要结局

Change in Children's Mental Health Problems Measured by SDQ

时间窗: 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.

Change in Teachers' Emotional Well-being

时间窗: 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.

Change in Parents/Caregivers' Emotional Well-being

时间窗: 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.

次要结局

  • 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))
  • Parents/Caregivers' Satisfaction with the Intervention Assessed by Likert Survey(After sessions 1, 2, and 3 (up to 16 weeks))
  • Change in Stress Reactivity Measured by Nail Cortisol(Baseline and 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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