Clinical trial NCT03548558: Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
Official title: Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Child Development
Keywords: Early Childhood Development
Parenting Behaviors
Group-based curriculum
Kenya
Child Outcomes
Community Health Volunteers
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Lunenfeld Tanenbaum Research Institute
name: Safe Water and AIDS Project
name: University of California, Berkeley
name: McGill University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-06-07
Enrollment: 1152
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The evaluation design is conducted in two phases. During phase 1, a clustered Randomized Control Trial (cRCT) across 60 community health volunteers (CHVs) and their associated villages are randomly assigned to one of three equally-sized treatment arms: group meetings for 16 biweekly sessions over 8 months (Arm 1), 12 group meetings plus 4 home visits over 8 months (Arm 2), and a control group (Arm 3). Within half of villages assigned to Arms 1 and 2, fathers will also be invited to the sessions (a 2x2 factorial design among the 40 villages assigned to receive the intervention). After a first follow-up survey immediately after the end of the biweekly sessions, in phase 2 we stratify by Arms 1 and 2 and re-randomize villages so that 20 total receive booster group sessions every 2 months over another 2 years (10 each from Arms 1 and 2). The other 20 villages from Arms 1 and 2 do not receive extended boosters.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Recent neurobiological and psychological research has established that vital development occurs in language, cognitive, motor and socio-emotional development during the first few years of life, and early life outcomes are key determinants of adult outcomes such as educational achievement, labor market outcomes, and health. Yet more than 200 million children under age five in low and middle income countries (LMICs) will fail to reach their developmental potential as adults, predominantly due to poverty, poor health and nutrition, and inadequate cognitive and psychosocial stimulation. Early childhood development (ECD) interventions that integrate nutrition and child stimulation activities have been proposed as a powerful policy tool for the remediation of early disadvantages in poor settings, and numerous field studies have shown they can be effective in improving children's developmental and health outcomes, at least in the short-term. Key questions remain on what models of delivery are the most effective and cost-effective that can be potentially scalable in LMICs, as well as how to sustain parental behavioral changes over time, which can lead to long-term improvements in child development and the possibility of positive spillovers to benefit younger siblings. Having a better understanding of the underlying behavioral pathways leading from intervention, to parental behavior changes, to child impacts, is also key to inform policy about the optimal design of interventions to maximize their scalability and sustainability. This study will conduct a multi-arm clustered randomized controlled trial across 60 villages and 1200 households in rural Western Kenya that tests different potentially cost-effective delivery models for an ECD intervention with a curriculum that integrates child psychosocial stimulation and nutrition education. Selected households will undergo baseline and follow-up surveys to measure short-term impacts in parental behaviors and children's developmental outcomes, and the study will collect data on potential mediators of parental behavioral change to uncover the pathways leading to impacts. Two follow-up surveys, one immediately after the end of the planned intervention and a second two years later, will enable testing of the short term and midterm sustainability of impacts, as well as the presence of any spillovers onto younger siblings. In collaboration with a local non-governmental organization (NGO), the Safe Water and AIDS Project (SWAP), community health volunteers (CHVs) will be trained to implement the intervention by introducing the ECD curriculum in their villages.

The goal of this study is to provide policymakers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings.

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.

Primary outcomes:
measure: Child Developmental Outcomes
timeFrame: Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.
measure: Child Developmental Outcomes
timeFrame: Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions
measure: Parenting Practices (HOME Observation for Measurement of the Environment - HOME)
timeFrame: Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).
measure: Parenting Practices (HOME Observation for Measurement of the Environment - HOME)
timeFrame: Month 35-37 Follow-up Survey (Arms 3, A and B).
Secondary outcomes:
measure: Child Height
timeFrame: Month 11/endline survey.
measure: Changes in Nutritional Practices
timeFrame: Month 11/endline survey (Arms 1, 2 with and without fathers, and Arm 3), and follow-up 2/month 35-37 survey (Arms 3, A and B).
Other outcomes:
measure: Changes in Perceived Social Support
timeFrame: Baseline, 10-12, and 22-24 months after intervention
measure: Changes in Relationship Support Scale
timeFrame: Baseline, 10-12, and 22-24 months after intervention
measure: Changes in Problem Solving/Social Support
timeFrame: Baseline, 10-12, and 22-24 months after intervention
measure: Changes in Maternal Depression
timeFrame: Baseline, 10-12, and 22-24 months after intervention
measure: Changes in Maternal Knowledge
timeFrame: Baseline, 10-12, and 22-24 months after intervention
measure: Changes in Maternal Beliefs
timeFrame: Baseline, 10-12, and 22-24 months after intervention
measure: Changes in Self-efficacy
timeFrame: Baseline, 10-12, and 22-24 months after intervention
Locations:
city: Los Angeles
country: United States
facility: USC
state: California
Study officials:
affiliation: University of Southern California
name: Jill E. Luoto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez Garcia I, Saya UY, Luoto JE. Cost-effectiveness and economic returns of group-based parenting interventions to promote early childhood development: Results from a randomized controlled trial in rural Kenya. PLoS Med. 2021 Sep 28;18(9):e1003746. doi: 10.1371/journal.pmed.1003746. eCollection 2021 Sep.
citation: Luoto JE, Lopez Garcia I, Aboud FE, Singla DR, Zhu R, Otieno R, Alu E. An Implementation Evaluation of A Group-Based Parenting Intervention to Promote Early Childhood Development in Rural Kenya. Front Public Health. 2021 May 5;9:653106. doi: 10.3389/fpubh.2021.653106. eCollection 2021.
citation: Luoto JE, Lopez Garcia I, Aboud FE, Singla DR, Fernald LCH, Pitchik HO, Saya UY, Otieno R, Alu E. Group-based parenting interventions to promote child development in rural Kenya: a multi-arm, cluster-randomised community effectiveness trial. Lancet Glob Health. 2021 Mar;9(3):e309-e319. doi: 10.1016/S2214-109X(20)30469-1. Epub 2020 Dec 17.
citation: Luoto JE, Lopez Garcia I, Aboud FE, Fernald LCH, Singla DR. Testing means to scale early childhood development interventions in rural Kenya: the Msingi Bora cluster randomized controlled trial study design and protocol. BMC Public Health. 2019 Mar 4;19(1):259. doi: 10.1186/s12889-019-6584-9.