跳至主要内容
临床试验/NCT07148531
NCT07148531进行中(未招募)不适用

Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings: A National-Scale RCT of Semillas de Apego in Colombia

University of Los Andes, Columbia12 个研究点 分布在 1 个国家目标入组 2,348 人开始时间: 2025年6月7日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,348
试验地点
12
主要终点
Caregiver Mental Health

研究概览

简要总结

The goal of this clinical trial is to learn if a community-based psychosocial program can improve caregivers' mental health and support the healthy development of young children in communities affected by conflict and forced displacement. The main questions it aims to answer are:

  • Does the at-scale implementation of the program improve caregivers' mental health?
  • Does improving caregivers' mental health improve the quality of the child-caregiver relationship and early childhood (socioemotional) development?

Researchers will compare caregivers who receive the program this year with those scheduled to receive it the following year to see if there are differences in caregiver mental health, the quality and style of the child-caregiver relationship, and child development outcomes.

Participants will:

  • Join a 15-week group program led by trained community facilitators
  • Take part in activities to build emotional regulation skills, strengthen caregiver-child relationships, encourage responsive caregiving, and expand social support networks

详细描述

This project evaluates the scale-up of a community-based psychosocial program designed to restore caregiver mental health and protect early childhood development in conflict-affected and displaced communities. The program promotes caregiver mental health as an outcome and as a pathway towards protecting young children in conflict-affected settings.

Young children and their caregivers in conflict-affected and displaced communities remain one of the most underserved groups in global health and development and are disproportionately exposed to trauma and adversity. While the long-term consequences of early adversity are well established, especially for children under five, few interventions have focused on addressing the immediate and interrelated needs of caregivers and young children in humanitarian settings. This gap is especially acute in programs that integrate caregiver mental health and child development, even though a large body of research shows that children's outcomes are deeply shaped by caregivers' mental health and their capacity to provide nurturing, sensitive care.

The program to be evaluated addresses this gap by treating caregiver mental health not only as an outcome, but as a mechanism to protect early childhood development. The intervention moves beyond psychoeducational models by creating a relational and reflective space led by trained community facilitators. These facilitators-caregivers themselves-draw on shared experiences to foster a relatable, stigma-free environment. This approach directly counters stigma, builds trust, and supports participation in settings where mental health services are limited and where there are also demand-side constraints for accessing these services.

The program is implemented through a 15-week group-based model with approximately 15 caregivers per group. The program follows four sequential goals: (1) promoting awareness of and tools for emotional regulation of the psychological consequences of conflict and forced displacement; (2) understanding children's emotional needs and the caregiver-child relationship; (3) developing responsive caregiving practices that foster secure attachment; and (4) strengthening social support networks. The approach integrates psychosocial support with attention to the social determinants of caregiving and mental health.

The program has undergone four stages of evaluation: a pilot study, a randomized controlled trial in one conflict-affected municipality, an at-scale pilot in four municipalities, and a mixed-methods evaluation of the added impact of integrating digital videos for socioemotional learning (developed by Sesame Workshop) on top of the standard program. Building on this evidence, this trial will evaluate the national scale-up, which reaches over 4,200 caregivers annually across 12 municipalities in partnership with local governments and community organizations. Using a phase-in randomized design to ensure an ethical approach, we will assess whether the program's positive effects and cost-effectiveness, as documented in the earlier RCT, are preserved when implemented at scale and across more heterogeneous populations, including victims of armed conflict, internally displaced persons, and Venezuelan refugees.

研究设计

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

入排标准

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

入选标准

  • Caregivers of children aged 0-5 residing in the 12 municipalities served by the program. These are largely municipalities affected by ongoing conflict, or reception sites of internally displaced persons or Venezuelan refugees.

排除标准

  • Caregivers exhibiting clinical symptoms of mental health problems. These are refered to clinical mental services.

结局指标

主要结局

Caregiver Mental Health

时间窗: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups

Mental Health index constructed following a latent-factor analysis as in Kling et al. (2007) using data from an instrument based on the adapted SCL-90-R, measuring anxiety, depression, phobic anxiety, sensitivity, and hostility.

Quality of the child-caregiver relationship

时间窗: 8-month post-intervention follow-up

Adapted version of the Observation of Mother-Child Interactions (OMCI) administered at the second follow-up only, 8 months post-intervention.

Style of the child-caregiver relationship

时间窗: Time Frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups

Index of style of the child-caregiver interactions constructed following a latent-factor analysis as in Kling et al. (2007) using data from the Parent Behavior Checklist.

Early childhood development (socioemotional)

时间窗: 8-month post-intervention follow-up

International Development Early Learning Assessment (IDELA), designed for children aged 3 to 6, assesses five developmental areas: motor skills, emergent literacy, emergent numeracy, social-emotional development, and executive functions. We will focus on social-emotional development and executive functions. Conditional on children's ages at the second follow-up, we will complement these measures with additional caregiver-reported scales such as the SDQ.

次要结局

未报告次要终点

研究者

发起方
University of Los Andes, Columbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres Moya

Associate Professor

University of Los Andes, Columbia

研究点 (12)

Loading locations...

相似试验