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NCT Number: NCT07148531

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semillas de Apego, Medellín, Antioquia, Colombia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seeds for Attachment (translated version)

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.

Primary outcomes

  1. Caregiver Mental Health

    Time frame: 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.

  2. Quality of the child-caregiver relationship

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

    Relationship index constructed following a latent-factor analysis as in Kling et al. (2007) using data from the Parenting Stress Index (short form).

  3. Quality of the child-caregiver relationship

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

    Child-Parent Relationship Scale (CPRS)

  4. Quality of the child-caregiver relationship

    Time frame: 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.

  5. Style of the child-caregiver relationship

    Time frame: 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.

  6. Early childhood development (socioemotional)

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

    Brief Toddler Socioemotional Assessment (BITSEA, (Briggs-Gowan et al., 2004)), a caregiver-reported scale that evaluates children's social-emotional development, including behavioral problems, developmental delays, and deficits in social-emotional competence.

  7. Early childhood development (socioemotional)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Los Andes, Columbia

Other

Collaborators

  • Conrad N. Hilton Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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