Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04210362
Status:
TERMINATED
Last Update Posted:
2022-08-25
First Post:
2019-07-14
Brief Title:
External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda
Sponsor:
Amado David Quezada Sánchez
Organization:
Mexican National Institute of Public Health
Study Overview
Official Title:
External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican Non-governmental Organization Un Kilo de Ayuda
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the Covid-19 contingency activities were suspended in March 2020 Baseline measurements were obtained for n764 children whose caregivers enrolled in the NPECDP-UKA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NPECDP-UKA
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 AC 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 01824 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
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 AC 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 01824 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None