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

August 22, 2022 updated by: Amado David Quezada Sánchez

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

764

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Oaxaca, Mexico
        • Un Kilo de Ayuda, A.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational intervention for 30 months
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.
Behavioral: Workshops on responsive caregiving
Caregivers will receive monthly workshops about several dimensions of nurturing care, responsive caregiving and early child development. Workshops will be reinforced through home visits.
Experimental: Educational intervention for 24 months
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.
Behavioral: Workshops on responsive caregiving
Caregivers will receive monthly workshops about several dimensions of nurturing care, responsive caregiving and early child development. Workshops will be reinforced through home visits.
Experimental: Educational intervention for 12 months
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.
Behavioral: Workshops on responsive caregiving
Caregivers will receive monthly workshops about several dimensions of nurturing care, responsive caregiving and early child development. Workshops will be reinforced through home visits.
No Intervention: Comparison group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Development Evaluation Test 2nd Edition (CDE-II)
Time Frame: 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)
Up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal McCarthy Scale of Children's Abilities (MSCA)
Time Frame: 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.
Up to 30 months
Perceptual-performance McCarthy Scale of Children's Abilities (MSCA)
Time Frame: 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.
Up to 30 months
Quantitative McCarthy Scale of Children's Abilities (MSCA)
Time Frame: 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.
Up to 30 months
Memory McCarthy Scale of Children's Abilities (MSCA)
Time Frame: 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.
Up to 30 months
Motor McCarthy Scale of Children's Abilities (MSCA)
Time Frame: 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.
Up to 30 months
General Cognitive Index from McCarthy Scales of Children's Abilities (MSCA)
Time Frame: 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.
Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amado David Quezada Sánchez

Collaborators

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Un Kilo de Ayuda A.C.

Investigators

  • Principal Investigator: Edson Serván-Mori, PhD, Mexican National Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

February 10, 2020

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1538/CI-896-2018/CB18-317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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