Experimental Evaluation of Semillas de Apego

NCT03502252 | Completed

• 1 other identifier: UANDES835
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

early childhood development; social and emotional development; secure parenting relationships

Outcome Measures

Primary Outcomes (6)

• Primary caregiver's mental health

  Measured with four sub-scales of the Symptom Checklist-90-R (Derogatis, 1994).

  1 month after the end of intervention

• Child rearing practices

  Measured with a measure asking caregivers whether they engaged in any of the following six stimulating activities with their children in the previous week: (1) reading stories or looking at books with images; (2) telling stories; (3) singing songs; (4) playing with child; (5) taking the child outside; and (6) spending time in physical activities with child. To analyze this construct as a composite measure, the researchers will computed a summary score ranging from zero (no engagement in any activity) to six (engagement in the six activities)

  1 month after the end of intervention

• Healthy child-parent emotional bonds

  Measured with the parenting stress-index (PSI, Adibin, 2012), a measure focused on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress. The researchers will analyze a composite measure of this scale and the individual sub-scales for the following domains: (i) parental distress, (ii) parent-child dysfunctional interaction, and (iii) difficult child.

  1 month after the end of intervention

• Children's mental health

  Measured with two separated scales reported by the caregiver. First, the researchers will employ an adapted measure of the Trauma Symptom Checklist for Young Children (TSCYC, Briere,2005) to describe child-levels of trauma and abuse-related symptomatology. Second, the researchers will employ the brief version of the Infant Toddler Social Emotional Assessment (BITSEA, Carter \& Briggs-Gowan, 2004) to screen for social, emotional, and behavioral problems in our population. For both scales, the researchers will focus on composite scores, but also provide detailed findings for each subscale.

  12 months after the end of the intervention

• Children's cognitive, social, and emotional development

  Measured with the international Development Learning Assessment (IDELA, Pisani, Borisova \& Dowd, 2015). This direct assessment tool, will describe the: (i) motor development, (ii) emergent language and literacy, (iii) emergent numeracy and problem solving, and (iv) socio-emotional skills of children.

  12 months after the end of the intervention

• Healthy child-parent emotional bonds

  Measured with an observation measured designed for this trial, this measure will describe the quality of the relationship between children and caregivers in the child-development center. An overall score will be produced and analyzed from observers' ratings to items targeting: (a) the quality of the interaction, (b) the cognitive stimulation provided in the situation, and (c) the emotional support provided during the situation.

  12 months after the end of the intervention

Secondary Outcomes (2)

• Children's mental health:

  1 month after end of the intervention

• Children's social, and emotional development.

  1 month after end of the intervention

Study Arms (2)

Treatment Group

EXPERIMENTAL

Semillas de Apego is a group-based psychosocial program for victimized caregivers with children 2 to 5 in Colombia, a country devastated by violence. The program's builds upon scientific evidence on (i) the way in which violence hinders early childhood development and erodes mothers' mental health and their capacity to form nurturing relationships with their children, and (ii) the effectiveness of promoting healthy child-parent attachments to mitigate the effects of toxic stress on toddlers (Lieberman and Van Horn, 2011).

Behavioral: Semillas de Apego

Control Group

NO INTERVENTION

Centers and participants assigned to the this group continue to have access to the regular early childhood programs offered through the centers to which children are affiliated.

Interventions

Semillas de Apego BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The experimental evaluation of Semillas de Apego will be conducted as a Cluster-Randomized Control Trial (C-RCT). The eligible population for the study are all families served by Genesis Foundation's Early Childhood Development Center (ECDC) in Tumaco, Colombia and whose children's ages range between 2 to 4 years of age. For example, for the first cohort, the children should have been born between August 1st, 2014 to April 1st, 2016

You may not qualify if:

• None

Sponsors & Collaborators

• University of Los Andes, Columbia: lead
• Genesis Foundation: collaborator

Study Sites (1)

Semillas de Apego

Tumaco, Departamento de Nariño, Colombia

Location

Study Officials

• Andres Moya, Ph.D

  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: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: March 5, 2018
• Primary Completion: April 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be available upon publication of the main evaluation article.

Locations

CO (1)