Improving Early Childhood Development in Zambia

NCT02234726 | Completed

• 1 other identifier: GCC 0349-03
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 2

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.

Conditions

Stunting; Child Development

Keywords

child health; child development; malnutrition; stunting; community-based health services

Outcome Measures

Primary Outcomes (2)

• Stunting

  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.

  One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline

• Cognitive function

  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.

  End line (after one year); Amendment: BSID-III at year two (extension) endline

Secondary Outcomes (3)

• Measles vaccine 2nd dose

  End line (one year)

• Treatment of severe acute malnutrition (SAM)

  Baseline and end line (one year)

• Caregiver awareness of child development

  Baseline and end line (one year)

Study Arms (2)

Early Childhood Development Program

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Early Childhood Development Program BEHAVIORAL

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.

Early Childhood Development Program

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zambia Center for Applied Health Research and Development: lead
• Grand Challenges Canada: collaborator
• PATH: collaborator
• Department for International Development, United Kingdom: collaborator

Study Sites (2)

Choma District Medical Office

Choma, Southern Province, Zambia

Location

Pemba District Medical Office

Pemba, Southern Province, Zambia

Location

Related Publications (2)

• Rockers PC, Zanolini A, Banda B, Chipili MM, Hughes RC, Hamer DH, Fink G. Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial. PLoS Med. 2018 Apr 24;15(4):e1002555. doi: 10.1371/journal.pmed.1002555. eCollection 2018 Apr.

  PMID: 29689045 DERIVED

• Rockers PC, Fink G, Zanolini A, Banda B, Biemba G, Sullivan C, Mutembo S, Silavwe V, Hamer DH. Impact of a community-based package of interventions on child development in Zambia: a cluster-randomised controlled trial. BMJ Glob Health. 2016 Nov 22;1(3):e000104. doi: 10.1136/bmjgh-2016-000104. eCollection 2016.

  PMID: 28588962 DERIVED

MeSH Terms

Conditions

Growth Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Davidson Hamer

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

ZA (2)