Child Development Clinical Trial
Official title:
Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya
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.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 15, 2025 |
Est. primary completion date | December 15, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Months and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Safe Water and AIDS Project | Kisumu |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Early Childhood Development Network for Kenya (ECDNeK), Safe Water and AIDS Project (SWAP) |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Maternal Depression | The Patient Health Questionnaire (PHQ-8) is a self-reported measure of depressive symptoms during the previous two weeks. It is composed of 8 Likert-style items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day). The PHQ-8 final score ranges from 0 to 24, with higher scores corresponding to higher levels of depression. | Midline/8-month survey, Endline/24-month survey | |
Primary | Child Cognitive Development - Bayley | 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. | Midline/8-month survey, Endline/24-month survey | |
Secondary | Parenting Behaviors | The Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory has four versions: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the endline/month 8 survey the HOME scale scores will range from 0-45, with higher scores denoting better outcomes. | Midline/8-month survey, Endline/24-month survey |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06315036 -
Effects of Developmental Gymnastics on Preschoolers' Motor Skills
|
N/A | |
Active, not recruiting |
NCT05143294 -
Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions
|
N/A | |
Completed |
NCT05267730 -
Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions
|
N/A | |
Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
Completed |
NCT00362076 -
The Role of Motion in Infants' Ability to Categorize
|
N/A | |
Recruiting |
NCT05525962 -
Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
|
||
Completed |
NCT03232606 -
Physical Activity of Asthmatic Children
|
||
Completed |
NCT05955755 -
The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear
|
N/A | |
Recruiting |
NCT04443855 -
WASH Benefits Child Development Follow up
|
N/A | |
Not yet recruiting |
NCT06335524 -
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
|
N/A | |
Not yet recruiting |
NCT05783141 -
Prebiotic Effects in Healthy Toddlers
|
N/A | |
Completed |
NCT02451059 -
Reducing Socioeconomic Disparities in Health at Pediatric Visits
|
N/A | |
Completed |
NCT02539251 -
Arabic Ages and Stages Questionnaire-III
|
||
Completed |
NCT02800616 -
The Healthy Elementary School of the Future
|
N/A | |
Completed |
NCT02242539 -
Tools to Improve Parental Recognition of Developmental Deficits in Children
|
N/A | |
Completed |
NCT03010306 -
CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru
|
N/A | |
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT00989859 -
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
|
||
Recruiting |
NCT00980733 -
Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
|
Phase 3 | |
Terminated |
NCT04347707 -
Building Regulation in Dual Generations
|
N/A |