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

NCT07148531 | Active Not Recruiting

• 1 other identifier: 8-2025
• Study Type: interventional
• Target: 2,348
• Locations: 1 country
• Sites: 12

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

Conditions

Mental Health; Child Development; Relationships, Father-Child

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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).

  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)

  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.

  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: 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.

  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.

  8-month post-intervention follow-up

Study Arms (2)

Treatment Arm - Early Intervention Group

EXPERIMENTAL

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)

Control Arm: Wait List / Later Treatment Group

EXPERIMENTAL

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)

Interventions

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.

Control Arm: Wait List / Later Treatment Group; Treatment Arm - Early Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Los Andes, Columbia: lead
• Conrad N. Hilton Foundation: collaborator

Study Sites (12)

Semillas de Apego

Medellín, Antioquia, Colombia

Location

Semillas de Apego

Barranquilla, Atlántico, Colombia

Location

Semillas de Apego

Malambo, Atlántico, Colombia

Location

Semillas de Apego

Soledad, Atlántico, Colombia

Location

Semillas de Apego

Bogotá, DC, Colombia

Location

Semillas de Apego

Montería, Departamento de Córdoba, Colombia

Location

Semillas de Apego

Tumaco, Departamento de Nariño, Colombia

Location

Semillas de Apego

Cúcuta, Norte de Santander Department, Colombia

Location

Semillas de Apego

Los Patios, Norte de Santander Department, Colombia

Location

Semillas de Apego

Villa del Rosario, Norte de Santander Department, Colombia

Location

Semillas de Apego

Cali, Valle del Cauca Department, Colombia

Location

Semillas de Apego

Jamundí, Valle del Cauca Department, Colombia

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Seeds

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andres Moya., PhD

  Economics. Universidad de los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 29, 2025
• Study Start: June 7, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: IPD will be shared upon the publication of the main trial article.
• Access Criteria: To be defined

Locations

CO (12)