Primary Outcomes (explanation)
Building upon the program’s theory of change and evidence from the CPP clinical trials (Lieberman and Van Horn, 2011), we will observe caregivers and children’s outcomes throughout two follow-ups after the end of the intervention. We will include reduced versions of instruments designed and adapted to address all five primary outcomes at each moment in the data collection (baseline, first and second follow-up). Nevertheless, we formulate differential hypotheses of the effect of the program on different constructs at different moments.
Below, we describe the schedule of data collection that we will implement for each cohort. We detail the psychometric scales and assessment instruments that will be included at each phase.
For each cohort, we will administer a detailed household survey prior to the start of the intervention. The survey includes nine different modules that aim to characterize subjects and their households according to the: (1) demographic composition of the household, (2) education attainment of the primary caregivers and head of the household, (3) labor participation and primary source of income for the household, (4) child composition of the household and basic health indicators, (5) parental locus of control, (6) reported household-level exposure to violence, (7) primary caregiver time-use; (8) living arrangements and physical conditions of the house, and (9) contact information for future assessment.
In addition, we will administer the following scales and instruments to assess the baseline level of our primary outcomes:
1) Primary caregiver’s mental health: Measured with four sub-scales of the Symptom Checklist-90-R (Derogatis, 1994). This self-reported measure asks caregivers to report on several indicators of emotional well-being and mental health experimented during the last 30 days. In our evaluation, we focus on the sub-scales providing indicators for the extent of symptoms for the following psychopathologies: (i) Anxiety, (ii) Depression, (iii) Phobic Anxiety, and (iv) Interpersonal Sensitivity.
2) Child rearing practices: Measured with a questionnaire in which caregivers report 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 we will computed a summary score ranging from zero (no engagement in any activity) to six (engagement in the six activities), as previously done in several studies (e.g., Bornstein & Putnick, 2012; Cabrera et al., 2011; Jeong et al., 2017; Jeong et al., 2016; Sun et al., 2016).
3) 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. We 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.
4) Children’s mental health: Measured with two separated scales reported by the caregiver. First, we 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, we 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, we will focus on composite scores, yet we will provide detailed findings for each subscale.
5) Children’s cognitive, 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. We will focus our report on a composite score, but also provide detailed findings for each subscale.
Additionally, at baseline and the two follow-up assessments we will record child height and weight. With this information, we will construct height and weight z-scores for each age cohort, and compare with WHO international scales. These anthropometric measures, in addition, become an additional indicator of the children’s development at baseline.
First Follow-Up: 1 month after end of intervention
For each cohort, we will re-assess all our participants in the aforementioned dimensions one month after the end of the treatment implementation. At this moment, we will also update key demographic and socioeconomic information to assess key socioeconomic changes. Following the program’s theory of change, at this phase of the data collection, our primary outcomes include the primary caregiver’s mental health, the caregiver´s report of child rearing practices, and the caregiver´s report of stress-index in parenting interactions (PSI, Adibin, 2012). We expect to observe positive effects at end line for the first two primary dimensions. For the latter, we may observe worse self-reported outcomes (higher levels of stress in the child-parent relation) in the treatment group relative to the control group. This, however would not be indicative of a negative effect of the intervention, but rather an improved understanding by the participants on the way in which trauma and adversities undermine the child-parent relationship.
Secondary outcomes at phase of data collection includes and observational measure of healthy child-parent emotional bonds, caregiver´s reports of children’s mental health (TSCYC and BITSEA), and direct assessment of social and emotional development of the child measured with the PSRA.
Second follow-up: 12 months after end of intervention
A year after the end of the implementation of the program for each cohort, we will again re-assess all our participants using the different scales and instruments described above to assess the key dimensions. Additionally, to better understand the change in the quality of the child-parent bond and children’s cognitive and socioemotional development, we will also administer the following instruments.
1) 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.
1) Children´s cognitive and social-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.