Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Over half a million children between 0 and 5 years of age in Colombia have been affected by a civil conflict that has spanned over six decades. Exposure to violence during early childhood, or being born to a household that has been formerly victimized, may have devastating consequences on early childhood cognitive and socio-emotional development. In doing so, violence can compromise the right to lead healthy and productive lives for thousands of children in Colombia. First, violence leaves a legacy of poverty and psychological trauma (Ibañez & Moya, 2010; Moya, 2018). Children who experienced violence during early childhood lag in cognitive, social, and emotional development, while exposure to violence increases the probability of child neglect (Harker, Moya, & Riveros, 2015; Cuartas, Harker, & Moya, 2015). Protecting children from effects of violence, toxic stress, and deficits in family care is therefore one of the key challenges as Colombia transitions into a post-conflict stage and for the construction of a more equal and peaceful society. More generally, identifying cost effective ways to protect children and children from the effects of violence, toxic stress, and deficits in maternal care is a key challenge in contexts of violence and humanitarian crises. Recent evidence exploring the effect of interventions to promote positive child-development suggest a promising path through the attention to their caregivers (Singla Kumbakumba, & Aboud, 2015; Rahman et al., 2013). Building from this evidence, in this trial the researchers will evaluate the effectiveness of a group-based psychosocial program (Semillas de Apego) for victimized caregivers with children 2 to 5 in Colombia, a country devastated by violence. The program promotes healthy child-parent attachments as a pathway for a proper development among children exposed to violence. By fostering caregivers' mental health and their capacity to become a source of emotional protection, the intervention helps children reach their full potential amid such traumatic circumstances. Delivered in a 15-week curriculum, Semillas de Apego first provides tools so that victimized caregivers can start processing their own trauma. Then, the program focuses on allowing a proper understanding of the child's development trajectories and how they affected by the experience of adversities (such as violence exposure). Finally, the curriculum works towards fostering positive child-rearing practices. Taken together, Semillas de Apego's curriculum aims to foster the healthy child-parent attachments that promote appropriate affect regulation and healthy emotional development in the midst of adverse circumstances. 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 1280 eligible subjects, nested within 18 child development centers, will be assigned 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03502252
Study type Interventional
Source University of Los Andes, Columbia
Contact
Status Completed
Phase N/A
Start date March 5, 2018
Completion date November 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT00362076 - The Role of Motion in Infants' Ability to Categorize N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03232606 - Physical Activity of Asthmatic Children
Completed NCT05955755 - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear N/A
Recruiting NCT04443855 - WASH Benefits Child Development Follow up N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05783141 - Prebiotic Effects in Healthy Toddlers N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT02539251 - Arabic Ages and Stages Questionnaire-III
Completed NCT02800616 - The Healthy Elementary School of the Future N/A
Completed NCT02242539 - Tools to Improve Parental Recognition of Developmental Deficits in Children N/A
Completed NCT03010306 - CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru N/A
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT00989859 - Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Recruiting NCT00980733 - Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits Phase 3
Terminated NCT04347707 - Building Regulation in Dual Generations N/A