External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda
- Conditions
- Child Development
- Interventions
- Behavioral: Workshops on responsive caregiving
- Registration Number
- NCT04210362
- Lead Sponsor
- Amado David Quezada Sánchez
- Brief Summary
Investing in early childhood development is one of the best cost-effective investments a country can make to boost long term economic growth, promote peaceful and sustainable societies, contribute to tackle poverty traps and eradicate inequality. It is also necessary to uphold the right of every child to survive and thrive. The single most powerful context for nurturing care is the immediate home, often mainly provided by mothers.
Although the Mexican government has implemented social programs in the past, some with nutrition and child development components, poor and isolated communities have not benefited as others easier to reach. This is particularly true for the State of Oaxaca given its orography, where higher levels of malnutrition and a higher risk of suboptimal neurodevelopment are present.
Since 1989, Un Kilo de Ayuda A.C. (UKA), a nongovernmental organization, has been involved in preventing child undernutrition in contexts of high poverty. Currently, UKA has 9 Early Childhood Development Centers distributed in 5 States of Mexico, including Oaxaca. UKA has developed the Neurological and Psycho-affective Early Childhood Development Program (NPECDP-UKA) that seeks to contribute to timely stimulation in children under 5 years of age and promote perceptual parenting practices. As part of the NPECDP-UKA, UKA redesigned their interventions to promote healthy nurturing care practices and responsive caregiving through workshops provided to caregivers and pregnant women, and with reinforcement through home visits.
It is in the interest of this study to evaluate the NPECDP-UKA through a variation of a stepped wedge cluster randomized trial. The study sample consists of participants from 80 municipalities of Oaxaca (\~50% with high or very high margination status), 20 municipalities were randomly assigned to each arm. Study arms differ by design on the time of exposure to the program (0,18,24 and 30 months at the final measurement). Subjects from all study groups share the characteristic to be enrolled in the NPECDP-UKA, the group with 0 months of exposure will serve as a comparison group. This distinctive characteristic of the study requires a progressive incorporation of study groups to be able to compare development measurements between study groups at the same ages and among subjects all enrolled in the program to avoid self-selection bias. The main study hypothesis states that children exposed to the Program will have better neurodevelopment outcomes than those not exposed.
This study will provide evidence of the effect of an educational intervention for caregivers on the neurodevelopment of children under 5 years of age. Currently evidence of such interventions is very limited, especially for interventions performed by a nongovernmental organization. This is the first evaluation of this kind in Mexico.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 764
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Educational intervention for 12 months Workshops on responsive caregiving Children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 12 months. Educational intervention for 30 months Workshops on responsive caregiving Children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 30 months. Educational intervention for 24 months Workshops on responsive caregiving Children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 24 months.
- Primary Outcome Measures
Name Time Method Child Development Evaluation Test 2nd Edition (CDE-II) Up to 30 months The CDE-II, or Evaluación del Desarrollo Infantil (EDI-II) in Spanish, was developed and validated in Mexico to screen populations for lag and for risk of delay in child development. The test has specific items for 14 age groups of children aged 1 to 60 months. Assessed developmental areas include gross motor skills, fine motor skills, language, social skills, and cognitive skills. The CDE-II is based on age-group specific items, score results are categorized into three levels: Green (normal development), Yellow (developmental lag) and Red (at risk of development delay)
- Secondary Outcome Measures
Name Time Method Verbal McCarthy Scale of Children's Abilities (MSCA) Up to 30 months The verbal MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Quantitative McCarthy Scale of Children's Abilities (MSCA) Up to 30 months The quantitative MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Memory McCarthy Scale of Children's Abilities (MSCA) Up to 30 months The memory MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Perceptual-performance McCarthy Scale of Children's Abilities (MSCA) Up to 30 months The perceptual-performance MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Motor McCarthy Scale of Children's Abilities (MSCA) Up to 30 months The motor MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
General Cognitive Index from McCarthy Scales of Children's Abilities (MSCA) Up to 30 months The General Cognitive Scale is obtained adding up the verbal, percetual-performance and quantitative MSCA and it is converted into the General Cognitive Index (GCI). The GCI has a mean set at 100 and a standard deviation of 16.
Trial Locations
- Locations (1)
Un Kilo de Ayuda, A.C.
🇲🇽Oaxaca, Mexico