Clinical trial NCT04210362: External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda
Official title: External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican Non-governmental Organization Un Kilo de Ayuda
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Development
Keywords: neurodevelopment
responsive caregiving
nuturing care
counseling
Lead sponsor: Mexican National Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Un Kilo de Ayuda A.C.
name: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
First posted: 2019-12-24
Enrollment: 764
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A variation of the stepped wedge cluster randomized trial design was specified. Due to ethical and logistical considerations, the intervention in study groups under this design starts sequentially but measurements are performed at the same time period in all groups. The key difference between groups is thus the time of exposure to the intervention. Clusters were randomized into four study groups (30, 24, and 12 months of exposure, and a non-exposed group). The intervention consists of educational workshops for caregivers aimed at promoting healthy nurturing care practices and responsive caregiving. Assessment of intervention effects is performed as in a parallel design.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria

* Communities: Municipalities in the State of Oaxaca where the NPECDP-UKA is not currently operating.
* Whithin selected communities:

children aged1 to 60 months and their caregivers who decided to enroll in the NPECDP-UKA.

Exclusion Criteria (communities):

* Communities: Municipalities in the State of Oaxaca with a population of children under 5 years of age below 35 habitants according to the Census of 2010

Primary outcomes:
measure: Child Development Evaluation Test 2nd Edition (CDE-II)
timeFrame: Up to 30 months
Secondary outcomes:
measure: Verbal McCarthy Scale of Children's Abilities (MSCA)
timeFrame: Up to 30 months
measure: Perceptual-performance McCarthy Scale of Children's Abilities (MSCA)
timeFrame: Up to 30 months
measure: Quantitative McCarthy Scale of Children's Abilities (MSCA)
timeFrame: Up to 30 months
measure: Memory McCarthy Scale of Children's Abilities (MSCA)
timeFrame: Up to 30 months
measure: Motor McCarthy Scale of Children's Abilities (MSCA)
timeFrame: Up to 30 months
measure: General Cognitive Index from McCarthy Scales of Children's Abilities (MSCA)
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Oaxaca
country: Mexico
facility: Un Kilo de Ayuda, A.C.
Study officials:
affiliation: Mexican National Institute of Public Health
name: Edson Serván-Mori, PhD
role: PRINCIPAL_INVESTIGATOR
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