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

Study Overview
=================
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 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.

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

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Behavioral: Workshops on responsive caregiving


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 60 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A variation of the stepped wedge cluster randomized trial design was specified. Due to ethical and logistical considerations, the intervention in study groups under this design starts sequentially but measurements are performed at the same time period in all groups. The key difference between groups is thus the time of exposure to the intervention. Clusters were randomized into four study groups (30, 24, and 12 months of exposure, and a non-exposed group). The intervention consists of educational workshops for caregivers aimed at promoting healthy nurturing care practices and responsive caregiving. Assessment of intervention effects is performed as in a parallel design.
Masking: None (Open Label)


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurodevelopment, responsive caregiving, nuturing care, counseling