Improving Early Childhood Development in Zambia

NCT02234726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2017-06-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the impact of a community-based early childhood development (ECD) program on children's physical and cognitive development. Under the program, targeted communities will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation. The investigators will enroll at baseline around 600 children ages 6 - 12 months and their caregivers, and randomize them at the community-level to receive the ECD program or to remain in the control group. The study period will be one year. At end line, the investigators will collect important indicators of child physical and cognitive development to assess program impact. If the program shows both feasibility and impact, there is the potential to integrate program interventions into existing national community-based health initiatives.

Amendment: the study period has been extended for a second year. After a five month gap when no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups were restarted in intervention clusters. In the second year of the intervention, CDAs no longer visit households.

Conditions

  • Stunting
  • Child Development

Interventions

BEHAVIORAL

Early Childhood Development Program

A cadre of community-based health workers, Child Development Agents (CDAs), have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases and referral for diagnosis and treatment; and 4) organization and mentoring of weekly meetings for caregivers to discuss parenting issues and promote early childhood cognitive stimulation. Amendment: during second year extension, CDAs are responsible for organizing and mentoring biweekly (i.e., fortnightly) caregiver meetings. They no longer conduct household visits.

Sponsors & Collaborators

  • Grand Challenges Canada

    collaborator OTHER
  • PATH

    collaborator OTHER
  • Department for International Development, United Kingdom

    collaborator OTHER_GOV
  • Zambia Center for Applied Health Research and Development

    lead OTHER

Principal Investigators

  • Davidson Hamer · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234726 on ClinicalTrials.gov