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Experimental Evaluation of Semillas de Apego

NCT03502252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2021-06-04

No results posted yet for this study

Summary

The current trial focuses on the effectiveness evaluation of Semillas de Apego in Tumaco, a municipality in Colombia heavily affected by violence and poverty. Over a time-span of 23 months, the researchers will follow the implementation of Semillas de Apego with 40 groups of 16 participants each, all of them mothers or primary caregivers of children 2 to 5. This will allow the researchers to reach a total of 640 participants and their children. The impact evaluation will be based on a cluster- randomized control trial in which the researchers will assign 1280 eligible subjects, nested within 18 child development centers, to either an intervention arm or a control group. The former group will participate in 15 group-led session over the period of 3 months; the latter will continue to have access to the regular early childhood programs offered through the centers to which children are affiliated. Data will be collected at baseline and two follow-ups: 1 and 12 months after the implementation has concluded. The researchers hypothesize that the program will have a positive and sequential impact on the following dimensions: (i) primary caregiver's mental health, (ii) child rearing practices, (iii) quality of child-parent emotional bond, (iv) children's mental health, and (v) children's cognitive and socioemotional development.

Conditions

  • Child Development
  • Attachment Disorder
  • Exposure to Violent Event
  • Parenting

Interventions

BEHAVIORAL

Semillas de Apego

Group-based Primary Caregiver Intervention: Group-based psychosocial program for victimized mothers (or alternative primary caregivers) with children 2 to 5, that aims at promoting healthy child-parent attachments as a pathway for a proper development among children exposed to violence.

Sponsors & Collaborators

  • Genesis Foundation

    collaborator OTHER

  • University of Los Andes, Columbia

    lead OTHER

Principal Investigators

  • Andres Moya, Ph.D · Universidad de Los Andes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2020-04-30
Completion
2020-11-30

Countries

  • Colombia

Study Locations

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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 NCT03502252 on ClinicalTrials.gov