Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings

NCT ID: NCT07148531

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-07
• Study Completion Date: 2026-08-30

Brief Summary

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

Detailed Description

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.

Conditions

Mental Health; Child Development; Relationships, Father-Child

Keywords

Caregiver Mental Health; Early Childhood Development; Conflict-Affected Populations; Refugees; IDPs; Community Psychosocial Model; Colombia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Arm - Early Intervention Group

Participants assigned to this arm will have the opportunity to participate in the community-based psychosocial program in the second semester of 2025-2, following a wait-list design. This will be the early-treatment group.

Group Type: EXPERIMENTAL

Seeds for Attachment (translated version)

Intervention Type: BEHAVIORAL

Developed by, and base at Universidad de los Andes, this is a community-based psychosocial model for caregivers of young children in conflict-affected settings.

The program is implemented through a 15-week group-based model with approximately 15 caregivers per group, and led by community facilitators (non-professionals).

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.

Control Arm: Wait List / Later Treatment Group

Participants assigned to this arm will have the opportunity to participate in the community-based psychosocial program in the second semester of 2026-2, after all data collection has been completed. Following a wait-list design, this will be the control or late-treatment group.

Group Type: EXPERIMENTAL

Seeds for Attachment (translated version)

Intervention Type: BEHAVIORAL

Developed by, and base at Universidad de los Andes, this is a community-based psychosocial model for caregivers of young children in conflict-affected settings.

The program is implemented through a 15-week group-based model with approximately 15 caregivers per group, and led by community facilitators (non-professionals).

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.

Interventions

Seeds for Attachment (translated version)

Developed by, and base at Universidad de los Andes, this is a community-based psychosocial model for caregivers of young children in conflict-affected settings.

The program is implemented through a 15-week group-based model with approximately 15 caregivers per group, and led by community facilitators (non-professionals).

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Conrad N. Hilton Foundation

OTHER

Sponsor Role: collaborator

University of Los Andes, Columbia

OTHER

Sponsor Role: lead

Responsible Party

Andres Moya

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andres Moya., PhD

Role: PRINCIPAL_INVESTIGATOR

Economics. Universidad de los Andes

Locations

Semillas de Apego

Medellín, Antioquia, Colombia

Semillas de Apego

Barranquilla, Atlántico, Colombia

Semillas de Apego

Malambo, Atlántico, Colombia

Semillas de Apego

Soledad, Atlántico, Colombia

Semillas de Apego

Bogotá, DC, Colombia

Semillas de Apego

Montería, Departamento de Córdoba, Colombia

Semillas de Apego

Tumaco, Departamento de Nariño, Colombia

Semillas de Apego

Cúcuta, Norte de Santander Department, Colombia

Semillas de Apego

Los Patios, Norte de Santander Department, Colombia

Semillas de Apego

Villa del Rosario, Norte de Santander Department, Colombia

Semillas de Apego

Cali, Valle del Cauca Department, Colombia

Semillas de Apego

Jamundí, Valle del Cauca Department, Colombia

Countries

Colombia

Other Identifiers

8-2025

Identifier Type: -

Identifier Source: org_study_id