N/A
N=1,152
Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
Early Child Development
Bottom Line
View on ClinicalTrials.gov: NCT03548558 ↗Enrolled (actual)
1,152
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Child Developmental Outcomes — 9.5; 9.4; 9.1; 9.1 age-standardized scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group sessions (Behavioral); Group+Home sessions (Behavioral); Booster sessions (Behavioral); Fathers invited (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Developmental Outcomes |
4.9; 5.2; 5.1; 14.4; 14.5; 14.4 | — |
| 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 | — |
| 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 | — |
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.
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.
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.