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Field
Trial End Date
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Before
January 19, 2024
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After
June 30, 2024
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Field
Last Published
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Before
May 12, 2023 05:24 PM
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After
June 07, 2024 02:36 PM
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Field
Intervention End Date
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Before
January 19, 2024
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After
May 31, 2024
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Field
Primary Outcomes (End Points)
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Before
1. Child Development: We will use the Caregiver-Reported Early Development Instruments - Long Form (CREDI).
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After
1. Child Development: We will use the Caregiver-Reported Early Development Instruments - Long Form (CREDI-LF) with a full sample and the Global Scales of Early Development - Long Form (GSED-LF) with a subsample.
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Field
Primary Outcomes (Explanation)
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Before
The CREDI is a parent-reported tool to measure child development using simple yes/no questions that has been used and validated in multiple countries, including Brazil, and demonstrates adequate psychometric properties to measure with precision motor, cognitive, language, and social-emotional development. We may also include additional measures of the child development if we receive additional funding to do so. These measures will focus on the same domains of child development, but will use direct assessment methods (to complement the parent-report approach of the CREDI).
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After
The CREDI-LF is a parent-reported tool to measure child development using simple yes/no questions that has been used and validated in multiple countries, including Brazil, and demonstrates adequate psychometric properties to measure with precision motor, cognitive, language, and social-emotional development.
The GSED-LF is a direct assessment of child development, and we use it to complement the parent-report approach of the CREDI. The GSED was developed by a large team of researchers led by the WHO (including Dr. McCoy), designed to be culturally-neutral, and validity evidence has been collected from multiple countries. While it covers multiple domains, it produces a single overall development score.
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Field
Public analysis plan
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Before
No
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After
Yes
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Field
Secondary Outcomes (End Points)
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Before
1. Caregiver mental health: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
2. Home learning environment: Family Care Indicators
3. Parenting knowledge, attitudes, and beliefs
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After
1. Caregiver mental health: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
2. Parents’ early stimulation: Family Care Indicators (FCI) and Parenting Styles and Dimensions Questionnaire (PSDQ)
3. Parents’ discipline behaviors: Conflict Tactics Scales: Parent-child Version (CTSPC)
4. Parent self-efficacy: Self-efficacy for Parenting Tasks Index-Toddler Scale (SEPTI-TS)
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Field
Secondary Outcomes (Explanation)
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Before
1. Caregiver mental health: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a self-reported measure to capture common symptoms of depression, anxiety, and overall stress for parents. The DASS-21 has been implemented in Latin America & the Caribbean and exhibit adequate validity and psychometric properties
2. Home learning environment: The Family Care Indicators (FCI) has been used extensively across low- and- middle- income countries and South America, in particular, in impact evaluations and large-scale household surveys (such as UNICEF’s Multiple Indicators Cluster Survey). The FCI will allow us to characterize caregivers’ engagement in stimulation and learning activities, such as playing, singing, or telling stories, and also the home learning environment, including the availability of books, toys, and playthings. We may also include additional measures of home learning environment if we receive additional funding to do so. These measures will focus on similar dimensions of home learning, but will use observational methods (to complement the parent-report approach of the FCI).
3. Parenting knowledge, attitudes, and beliefs: We will use a set of questions that have been previously used in the context of South America in impact evaluations in the region and has been validated and shown to have adequate psychometric properties. The instrument is intended to measure caregiver knowledge, attitudes, and beliefs on basic developmental processes (e.g., timing of developmental milestones) and basic parenting practices.
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After
1. Caregiver mental health: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a self-reported measure to capture common symptoms of depression, anxiety, and overall stress for parents. The DASS-21 has been implemented in Latin America & the Caribbean and exhibits adequate validity and psychometric properties. We will use the Depression and Stress scales
2. Parents’ early stimulation: The Family Care Indicators (FCI) have been used extensively across low- and- middle-income countries and South America, particularly in impact evaluations and large-scale household surveys (such as UNICEF’s Multiple Indicators Cluster Survey). The FCI will allow us to characterize caregivers’ engagement in stimulation and learning activities, such as playing, singing, or telling stories. To complement the FCI, specifically focusing on positive stimulation related to the non-cognitive development of the child, we add a few items from the Warmth and Support domain of the PSDQ (Oliveira et al., 2018).
3. Parents’ discipline behaviors: The CTSPC is a parent report measure of their discipline behaviors, originally developed and validated in the US (Straus et al., 1998) and also validated in Brazilian (Bonfim et al., 2011; Reichenheim & Moraes, 2006). Specifically, we will use a subset of the CTSPC, including some items in the Minor Physical Assault and Psychological Aggression domains, which are related to physical and psychological discipline behaviors relatively common in Brazil.
4. Parenting self-efficacy: The SEPTI-TS was originally developed in the U.S. (Coleman & Karraker, 2003) and has undergone validation for diverse populations, including the Dutch population (van Rijen et al., 2014) and the French-speaking population (Meunier & Roskam, 2009). We decided to use a subset of the Self-efficacy for Parenting Tasks Index-Toddler Scale (SEPTI-TS; Coleman & Karraker, 2003). Specifically, we use items from the Nurturance/Valuing/Empathetic Responsiveness, Play, and Teaching domains.
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