N/A Completed N=1,152 Randomized Single-blind Health Services Research

Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

Early Child Development

Source: ClinicalTrials.gov NCT03548558 ↗

Enrolled (actual)

1,152

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcomePrimary: Child Developmental Outcomes — 9.5; 9.4; 9.1; 9.1 age-standardized scores on a scale

Summary

This study aims to experimentally test the effectiveness and cost-effectiveness of competing models of delivery of an Early Childhood Development (ECD) intervention in rural Kenya to determine how to maximize their reach to improve child cognitive, language and relevant psychosocial outcomes. The study will also include a longer-term evaluation of sustained impacts; an examination of the pathways of change leading to intervention impacts to inform policy; and examination of the role of paternal involvement on child development. Findings will provide policy makers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings to improve child developmental outcomes for both the short-and longer-term.

Outcome Measures

Outcome	Result	p-value
PRIMARY Child Developmental Outcomes	4.9; 5.2; 5.1; 14.4; 14.5; 14.4	—
PRIMARY Parenting Practices (HOME Observation for Measurement of the Environment - HOME)	36.7; 38.5; 37.6	—
SECONDARY Child Height	-1.39; -1.42; -1.43; -1.46; -1.29	—
SECONDARY Changes in Nutritional Practices	4.3; 4.3; 4.1; 4.0; 4.1; 3.8	—

Eligibility Criteria

Inclusion Criteria

Kenyan mothers or equivalent female primary caretakers aged 15 and over with children aged 6-24 months (classified as mature minors)
Kenyan fathers aged 18 and older with children aged 6-24 months with a mother present

The unit of observation for the study is the household or family, within which the primary focus is mother-child dyads and household eligibility hinges on the age of the child. For those households with a father present, the study will additionally include him in some analyses and surveys.

Exclusion Criteria

Households without children
Households with children that are outside the age range of 6-24 months at baseline
Households with a mother younger than 15 or one aged 15-18 still living with her parents
Single fathers

Selection criteria for fathers are based on the mother-child eligibility criteria. Fathers will be included if and when appropriate per the details surrounding the mother-child dyads.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03548558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.