Child Development Clinical Trial
Official title:
Experimental Evaluation of Semillas de Apego, a Group-based Program to Foster Maternal Mental Health and Early Childhood Development Among Violence Exposed Communities in Colombia.
Verified date | May 2021 |
Source | University of Los Andes, Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1280 |
Est. completion date | November 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 4 Years |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
Colombia | Semillas de Apego | Tumaco | Nariño |
Lead Sponsor | Collaborator |
---|---|
University of Los Andes, Columbia | Genesis Foundation |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 will also provide detailed findings for each subscale. | 1 month after end of the intervention | |
Secondary | Children's social, and emotional development. | Measured at baseline with an adapted version of the Preschool Self-Regulatory Assessment (PSRA, Smith-Donald, Raver, Hayes & Richardson, 2007). This tool will provide independent scores of self-regulations in emotional, attentional, and behavioral domains. The researchers will focus our report on a composite score, but also provide detailed findings for each subscale. | 1 month after end of the intervention |
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