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

NCT07148531 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2348

Last updated 2025-08-29

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Conrad N. Hilton Foundation

    collaborator OTHER

  • University of Los Andes, Columbia

    lead OTHER

Principal Investigators

  • Andres Moya., PhD · Economics. Universidad de los Andes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-07
Primary Completion
2026-08-30
Completion
2026-08-30

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148531 on ClinicalTrials.gov