Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings: A National-Scale RCT of Semillas de Apego in Colombia
Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings: A National-Scale RCT of Semillas de Apego in Colombia
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:
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:
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.
Findings will inform the potential and scalability of community-based psychosocial models in humanitarian settings and shed light on the importance of targeting caregiver mental health and early childhood development within a unified lens to prevent the intergenerational transmission of trauma and poverty.
Inclusion Criteria:
Exclusion Criteria: