External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda (NPECDP-UKA)

Amado David Quezada Sánchez

Status: Terminated

Conditions: Child Development

Treatments: Behavioral: Workshops on responsive caregiving

Study type: Interventional

Funder types: Other

Identifiers

NCT04210362

1538/CI-896-2018/CB18-317

Details and patient eligibility

About

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.

Enrollment: 764 patients

Sex: All

Ages: 1 to 60 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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764 participants in 4 patient groups

Educational intervention for 30 months

Experimental group

Description:

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.

Treatment:

Behavioral: Workshops on responsive caregiving

Educational intervention for 24 months

Experimental group

Description:

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.

Treatment:

Behavioral: Workshops on responsive caregiving

Educational intervention for 12 months

Experimental group

Description:

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.

Treatment:

Behavioral: Workshops on responsive caregiving

Comparison group

No Intervention group

Description:

Group comprised of children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca, Mexico. Children and their caregivers will not be exposed to the intervention at the moment of their measurements.