Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Early Childhood Development in Zambia (IECDZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234726
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : June 20, 2017
Sponsor:
Collaborators:
Grand Challenges Canada
PATH
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Zambia Center for Applied Health Research and Development

Brief 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.


Condition or disease Intervention/treatment Phase
Stunting Child Development Behavioral: Early Childhood Development Program Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improving Early Childhood Development in Zambia
Actual Study Start Date : August 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Childhood Development Program

Treatment clusters 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.

Amendment: during second year extension, CDAs are responsible for organizing and mentoring biweekly (i.e., fortnightly) caregiver meetings. They no longer conduct household visits.

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.


No Intervention: Control
Children residing in comparison health zones will only receive baseline and end line evaluations of their health and developmental status. There will be no active intervention in the comparison areas during the course of the study.



Primary Outcome Measures :
  1. Stunting [ Time Frame: One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline ]
    Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard WHO criteria. Stunting will be defined as having a height-for-age z-score < -2. The difference in the prevalence of stunting between children in the intervention and comparison areas will be determined.

  2. Cognitive function [ Time Frame: End line (after one year); Amendment: BSID-III at year two (extension) endline ]

    Study children will be assessed at end line using the INTERGROWTH 21st century instrument. Scores will be standardized within the study sample for analysis. Scores of children in intervention health zones will be compared with children in comparison areas to determine differences.

    Amendment: at year two (extension) endline, children are assessed using the Bayley Scale for Infant and Toddler Development (BSID-III). Scores are standardized within the study sample for analysis.



Secondary Outcome Measures :
  1. Measles vaccine 2nd dose [ Time Frame: End line (one year) ]
    We will collect data on whether study children have received a second dose of measles vaccine; Zambian Ministry of Health guidelines indicate that a second dose should be given to all children at age 15 months.

  2. Treatment of severe acute malnutrition (SAM) [ Time Frame: Baseline and end line (one year) ]
    Caregivers will be asked to report on whether a child received treatment for SAM at a health center.

  3. Caregiver awareness of child development [ Time Frame: Baseline and end line (one year) ]
    Caregivers will be asked at baseline and end line about their child's nutritional and developmental status, and their responses will be compared to objective measures (e.g., stunting, INTERGROWTH z-score).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Child ages 6 to 12 months at the time of intervention launch residing in the catchment areas of the five study health facilities
  • Child's mother or main caregiver must be 15 years or older
  • Child's primary caregiver must be a female (because the participants in the caregiver groups may feel uncomfortable discussing certain issues if a man is present)

Exclusion criteria

  • Caregivers who are unwilling to provide informed consent
  • Families that plan to move from their health center catchment zone during the twelve month period of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234726


Locations
Layout table for location information
Zambia
Choma District Medical Office
Choma, Southern, Zambia
Pemba District Medical Office
Pemba, Southern, Zambia
Sponsors and Collaborators
Zambia Center for Applied Health Research and Development
Grand Challenges Canada
PATH
Department for International Development, United Kingdom
Investigators
Layout table for investigator information
Principal Investigator: Davidson Hamer Boston University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Zambia Center for Applied Health Research and Development
ClinicalTrials.gov Identifier: NCT02234726    
Other Study ID Numbers: GCC 0349-03
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zambia Center for Applied Health Research and Development:
child health
child development
malnutrition
stunting
community-based health services
Additional relevant MeSH terms:
Layout table for MeSH terms
Growth Disorders
Pathologic Processes