CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,152 enrolled
Drug / intervention
Group sessions +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03548558
NCT03548558N/ACompleted

Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

University of Southern California·interventional·Posted Jun 7, 2018·Updated Oct 13, 2023

In Brief

A clinical study evaluating Group sessions, Group+Home sessions, and 2 other interventions for Early Child Development. Completed, enrolled 1,152 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 7, 2018
Enrollment StartOct 1, 2018
Primary CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.1 years ago

Interventions

Group sessionsbehavioral

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 sessionsbehavioral

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 sessionsbehavioral

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.

Fathers invitedbehavioral

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.