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

Child Development Clinical Trial

— NPECDP-UKA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04210362
• Other study ID #: 1538/CI-896-2018/CB18-317
• Status: Terminated
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: August 2022
• Source: Mexican National Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 764
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

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.

Locations

Country	Name	City	State
Mexico	Un Kilo de Ayuda, A.C.	Oaxaca

Sponsors (3)

Lead Sponsor	Collaborator
Amado David Quezada Sánchez	Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes, Un Kilo de Ayuda A.C.

Country where clinical trial is conducted

Mexico, 

References & Publications (22)

Bick J, Nelson CA. Early Adverse Experiences and the Developing Brain. Neuropsychopharmacology. 2016 Jan;41(1):177-96. doi: 10.1038/npp.2015.252. Epub 2015 Sep 3. Review. — View Citation

Blair C, Razza RP. Relating effortful control, executive function, and false belief understanding to emerging math and literacy ability in kindergarten. Child Dev. 2007 Mar-Apr;78(2):647-63. — View Citation

Britto PR, Engle P. Parenting education and support: maximizing the most critical enabling environment. In: Marope P, Kaga Y, editors. Investing against evidence: the global state of early childhood care and education. 1st ed. Paris, France; 2015. p. 157.

Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4. Review. — View Citation

Caspi A, Moffitt TE, Newman DL, Silva PA. Behavioral observations at age 3 years predict adult psychiatric disorders. Longitudinal evidence from a birth cohort. Arch Gen Psychiatry. 1996 Nov;53(11):1033-9. — View Citation

Child C on the D. The Science of Early Childhood Development Closing the Gap Between What We Know and What We Do [Internet]. Cambridge, MA 02138; 2007. Available from: https://developingchild.harvard.edu/wp-content/uploads/2015/05/Science_Early_Childhood_Development.pdf

Consejo Nacional de Evaluación de la Política de Desarrollo Social (CONEVAL). Estadísticas de pobreza en Oaxaca [Internet]. Información de Pobreza y Evaluación de las Entidades Federativa. Available from: https://www.coneval.org.mx/coordinacion/entidades/Oaxaca/Paginas/principal.aspx

Delalibera BR, Ferreira PC. Early childhood education and economic growth. J Econ Dyn Control. 2019;98:82-104

Duncan GJ, Dowsett CJ, Claessens A, Magnuson K, Huston AC, Klebanov P, Pagani LS, Feinstein L, Engel M, Brooks-Gunn J, Sexton H, Duckworth K, Japel C. School readiness and later achievement. Dev Psychol. 2007 Nov;43(6):1428-1446. doi: 10.1037/0012-1649.43.6.1428. Erratum in: Dev Psychol. 2008 Jan;44(1):232. — View Citation

Force LMT. Toward Universal Learning: What Every Child Should Learn. Washington/Montreal: Brookings/UIS. 2013

Heckman J, Carneiro P. Human capital policy. Cambridge, MA 02138: National Bureau of Economic Research; 2003. (NBER Working Paper). Report No.: 9495

Heckman JJ, Moon SH, Pinto R, Savelyev P, Yavitz A. A new cost-benefit and rate of return analysis for the Perry Preschool Program: A summary. Cambridge, MA 02138: National Bureau of Economic Research; 2010. (NBER Working Paper). Report No.: 16180

Heckman JJ. Skill formation and the economics of investing in disadvantaged children. Science. 2006 Jun 30;312(5782):1900-2. — View Citation

Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. Review. — View Citation

McCarthy D. McCarthy Scales of Childrens Abilities. New York: The Psychological Corporation. 1972.

National Research Council (US) and Institute of Medicine (US) Committee on Integrating the Science of Early Childhood Development; Shonkoff JP, Phillips DA, editors. From Neurons to Neighborhoods: The Science of Early Childhood Development. Washington (DC): National Academies Press (US); 2000. — View Citation

Organization WH, Fund UNC, Group WB. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential. Ginebra 27, Suiza: World Health Organization; 2018

Shonkoff JP, Boyce WT, McEwen BS. Neuroscience, molecular biology, and the childhood roots of health disparities: building a new framework for health promotion and disease prevention. JAMA. 2009 Jun 3;301(21):2252-9. doi: 10.1001/jama.2009.754. — View Citation

Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26. — View Citation

The United Natons Children's Fund (UNICEF). The 2030 Agenda for Sustainable Development [Internet]. UNICEF and the SDGs. 2016. Available from: https://www.unicef.org/agenda2030/69525.html

Van der Gaag J, Tan J-P. The benefits of early child development programs: an economic analysis. World Bank Group; 1998

Young ME. Addressing and mitigating vulnerability across the life cycle: The case for investing in early childhood. UNDP Hum Dev Rep Off. 2014

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Development Evaluation Test 2nd Edition (CDE-II)	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	Verbal McCarthy Scale of Children's Abilities (MSCA)	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
Secondary	Perceptual-performance McCarthy Scale of Children's Abilities (MSCA)	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
Secondary	Quantitative McCarthy Scale of Children's Abilities (MSCA)	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
Secondary	Memory McCarthy Scale of Children's Abilities (MSCA)	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
Secondary	Motor McCarthy Scale of Children's Abilities (MSCA)	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
Secondary	General Cognitive Index from McCarthy Scales of Children's Abilities (MSCA)	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