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Clinical Trials/NCT06140017
NCT06140017
Active, Not Recruiting
N/A

Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya

University of Southern California1 site in 1 country1,200 target enrollmentOctober 24, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development
Sponsor
University of Southern California
Enrollment
1200
Locations
1
Primary Endpoint
Child Cognitive Development - Bayley
Status
Active, Not Recruiting
Last Updated
11 months ago

Overview

Brief Summary

An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term.

The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. Study investigators recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and a group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program.

Registry
clinicaltrials.gov
Start Date
October 24, 2023
End Date
April 30, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Italo Lopez Garcia

Principal Investigator

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • mothers or other primary caretakers aged 18 years or older
  • able to read English or Swahili at a level sufficient to understand the SMS messages
  • with a child aged 6-18 months at recruitment without signs of severe mental or physical impairments (youngest child if more than one eligible for a given mother)

Exclusion Criteria

  • mothers/households without children
  • households with children that are outside the age range of 6-18 months at baseline
  • mothers who lack basic literacy so as not to understand SMS messages

Outcomes

Primary Outcomes

Child Cognitive Development - Bayley

Time Frame: Midline/8-month survey, Endline/24-month survey

The Bayley Scales of Infant Development 3rd edition (Bayley's III) is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive scale has a 0-19 range with higher values denoting better scores.

Secondary Outcomes

  • Parenting Behaviors(Midline/8-month survey, Endline/24-month survey)

Study Sites (1)

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