Integrating a Package of Home-based Early Childhood Intervetions into Existing Community Health Worker Protocols in South Africa: A Cluster Randomized

Not Applicable

• Conditions: Biomarkers of systemic inflammation Mental and Behavioural Disorders

• Registration Number: PACTR201710002683810
• Lead Sponsor: Health Economics and Epidemiology Research Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2236

Inclusion Criteria

The primary eligibility criterion for CHWs is that they must be currently active at the time of the study and they must be conducting home-based child health visits as part of their routine activities. Nearly all CHWs in the District meet these criteria. Other eligibility criterion for CHWs include:
1.Must be a CHW for more than three months
2.Must be at least 18 years of age or older
3.Must have completed the Phase I training
4.Must not be using mHealth as part of routine activities
5.Must not be enrolled or actively participating in another research project
6.Must be willing to provide informed consent

Inclusion criteria for child/caregiver pairs
i.Households within study CHW catchment areas with a child recruited soon after birth, but within 90 days from when the CHW completes training and starts enrolling households in that cluster.
ii.Mother or primary care giver must be 18 years or older;

Exclusion Criteria

Exclusion criteria for child/caregiver pairs
i.Caregivers who are unwilling to provide informed consent;
ii.Families that plan to move from their CHW catchment zone during the twelve month period of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean HAZ (and stunting, defined as HAZ < -2): Heights of study children will be measured at baseline and endline; HAZ will be computed according to WHO child growth standards.;BSID-III composite scores: Study children will be assessed at endline using the BSID-III, which includes five domains of neurocognitive development: cognition; language; motor; adaptive behavior; and social-emotional.

Secondary Outcome Measures

Name	Time	Method
An assessment of the feasibility of the intervention package