An interventional study of Seeds for Attachment (translated version) in Mental Health, Child Development and Relationships, Father-Child, sponsored by University of Los Andes, Columbia. Active, not recruiting at 12 sites in Colombia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by University of Los Andes, Columbia · Not applicable, Interventional, and Treatment
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.
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's enrollment of 2,348 is above the median of 116 across 830 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Los Andes, Columbia is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Seeds for Attachment (translated version)
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.
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.
Caregiver Mental Health
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.
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Quality of the child-caregiver relationship
Relationship index constructed following a latent-factor analysis as in Kling et al. (2007) using data from the Parenting Stress Index (short form).
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Quality of the child-caregiver relationship
Child-Parent Relationship Scale (CPRS)
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Quality of the child-caregiver relationship
Adapted version of the Observation of Mother-Child Interactions (OMCI) administered at the second follow-up only, 8 months post-intervention.
Time frame: 8-month post-intervention follow-up
Style of the child-caregiver relationship
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.
Time frame: Time Frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Early childhood development (socioemotional)
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.
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Early childhood development (socioemotional)
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.
Time frame: 8-month post-intervention follow-up
Plan to share: Yes — Anonymized data for replication
Supporting information: Study protocol, Sap, Csr, Analytic code
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Los Andes, Columbia