NCT04210362: NPECDP-UKA

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

Terminated NA Last updated 25 August 2022

What this trial tests

NA trial testing Workshops on responsive caregiving in Child Development in 764 participants. Terminated before completion.

Timeline

15 July 2019

Primary endpoint
10 February 2020

10 February 2020

Quick facts

Lead sponsor	Amado David Quezada Sánchez
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	764
Start date	15 July 2019
Primary completion	10 February 2020
Estimated completion	10 February 2020
Sites	1 location across Mexico

Drugs / interventions tested

• Workshops on responsive caregiving

Conditions studied

• Child Development — all drugs for Child Development →

Sponsor

Amado David Quezada Sánchez

Who can join

Adults 1 Month to 60 Months, any sex, with Child Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessing the effect of an educational intervention on early childhood development among Mexican preschool children in the state of Oaxaca: a study protocol of a cluster randomized stepped-wedge trial.
   Quezada-Sánchez AD, Fuentes-Rivera E, García-Martínez A, Del Carmen Hernández-Chávez M, et al · · 2022 · cited 3× · PMID 35130939 · DOI 10.1186/s13063-022-06024-2
2. Proximal determinants of suboptimal early child development during the first three years of life in socially deprived Mexican contexts.
   Serván-Mori E, Quezada-Sánchez AD, Fuentes-Rivera E, Pineda-Antunez C, et al · · 2023 · cited 2× · PMID 37917638 · DOI 10.1371/journal.pone.0291300
3. Early neurological development and nutritional status in Mexican socially deprived contexts.
   Serván-Mori E, Fuentes-Rivera E, Quezada AD, Pineda-Antunez C, et al · · 2022 · cited 1× · PMID 35727758 · DOI 10.1371/journal.pone.0270085
4. A behavioral economics analysis of the participation in early childhood development social programs promoted by civil societies in Mexico.
   Serván-Mori E, Pineda-Antúnez C, Bravo-Ruiz ML, Molina M, et al · · 2022 · cited 1× · PMID 35353841 · DOI 10.1371/journal.pone.0265389
5. Maternal depressive symptomatology and its association with early child development in socioeconomically deprived Mexican households.
   Quezada-Sánchez AD, Vesterinen MS, Kinnunen TI, Hernández-Chávez C, et al · · 2026 · PMID 42154422 · DOI 10.1007/s44192-026-00477-6