Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

NCT ID: NCT03548558

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-10-15

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.

Conditions

Early Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Arm 1 ("group" sessions)

Group meetings only (16 total)

Group Type: EXPERIMENTAL

Group sessions

Intervention Type: BEHAVIORAL

Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.

Arm 2 ("group+home" sessions)

Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits)

Group Type: EXPERIMENTAL

Group+Home sessions

Intervention Type: BEHAVIORAL

Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.

Arm 3

This arm will serve as the control group to identify the effects of a parenting intervention and the most effective mode of delivery, as well as the sustained impacts from the intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm B (Booster villages)

In one half of Arm 1 and Arm 2 villages above, after the end of the main intensive intervention, extended light-touch group booster sessions held every other month over two years between the two follow-up surveys will be held

Group Type: EXPERIMENTAL

Group sessions

Intervention Type: BEHAVIORAL

Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.

Group+Home sessions

Intervention Type: BEHAVIORAL

Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.

Booster sessions

Intervention Type: BEHAVIORAL

After the end of the 16 biweekly sessions (phase 1), we will re-randomize across the 40 intervention villages, stratified by Arms 1 and 2, and half of each of Arm 1 and Arm 2 villages will receive group booster visits every other month for the period between end-line and follow-up surveys. This will constitute Phase 2 of the study.

Arm A (Non-booster villages)

In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2

Group Type: OTHER

Group sessions

Intervention Type: BEHAVIORAL

Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.

Group+Home sessions

Intervention Type: BEHAVIORAL

Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.

Arm X: Fathers invited

During phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages.

Group Type: EXPERIMENTAL

Group sessions

Intervention Type: BEHAVIORAL

Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.

Group+Home sessions

Intervention Type: BEHAVIORAL

Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.

Fathers invited

Intervention Type: BEHAVIORAL

During phase 1's 16 biweekly sessions, in half of Arm 1 and Arm 2 villages (20 total), fathers will additionally be invited to attend the 16 sessions. Separate father-only sessions will be held for 4 of the 16 sessions. This randomization will end after phase 1.

Arm Y: Fathers not invited

During phase 1, fathers were not invited in the other half of Arms 1 and 2 villages.

Group Type: OTHER

Group sessions

Intervention Type: BEHAVIORAL

Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.

Group+Home sessions

Intervention Type: BEHAVIORAL

Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.

Interventions

Group sessions

Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.

Intervention Type: BEHAVIORAL

Group+Home sessions

Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.

Intervention Type: BEHAVIORAL

Booster sessions

After the end of the 16 biweekly sessions (phase 1), we will re-randomize across the 40 intervention villages, stratified by Arms 1 and 2, and half of each of Arm 1 and Arm 2 villages will receive group booster visits every other month for the period between end-line and follow-up surveys. This will constitute Phase 2 of the study.

Intervention Type: BEHAVIORAL

Fathers invited

During phase 1's 16 biweekly sessions, in half of Arm 1 and Arm 2 villages (20 total), fathers will additionally be invited to attend the 16 sessions. Separate father-only sessions will be held for 4 of the 16 sessions. This randomization will end after phase 1.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lunenfeld Tanenbaum Research Institute

OTHER

Sponsor Role: collaborator

Safe Water and AIDS Project

OTHER

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Jill Luoto

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill E. Luoto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34582449 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34026713 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33341153 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30832624 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21HD098508

Identifier Type: NIH

Identifier Source: secondary_id

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R01HD090045

Identifier Type: NIH

Identifier Source: secondary_id

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1R01HD090045

Identifier Type: NIH

Identifier Source: org_study_id

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