Clinical trial NCT06140017: Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya
Official title: Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Child Behavior
Language, Child
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Early Childhood Development Network for Kenya (ECDNeK)
name: Safe Water and AIDS Project
First posted: 2023-11-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Child Cognitive Development - Bayley
timeFrame: Midline/8-month survey, Endline/24-month survey
Secondary outcomes:
measure: Parenting Behaviors
timeFrame: Midline/8-month survey, Endline/24-month survey
Other outcomes:
measure: Maternal Depression
timeFrame: Midline/8-month survey, Endline/24-month survey
Locations:
city: Kisumu
country: Kenya
facility: Safe Water and AIDS Project
Study officials:
affiliation: University of Southern California
name: Italo Lopez Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Jill E Luoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: