Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings (NCT07148531)
Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings: A National-Scale RCT of Semillas de Apego in Colombia
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Semillas de Apego — Medellín, Antioquia
Age range: 18 Years
🧪 Interventions in This Study
- Seeds for Attachment (translated version) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Semillas de Apego — Medellín, Antioquia
- Semillas de Apego — Barranquilla, Atlántico
- Semillas de Apego — Malambo, Atlántico
- Semillas de Apego — Soledad, Atlántico
- Semillas de Apego — Bogotá, DC
- Semillas de Apego — Montería, Departamento de Córdoba
- Semillas de Apego — Tumaco, Departamento de Nariño
- Semillas de Apego — Cúcuta, Norte de Santander Department
- Semillas de Apego — Los Patios, Norte de Santander Department
- Semillas de Apego — Villa del Rosario, Norte de Santander Department
- Semillas de Apego — Cali, Valle del Cauca Department
- Semillas de Apego — Jamundí, Valle del Cauca Department
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.