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Clinical Trials/NCT03991182
NCT03991182
Completed
N/A

Evaluation of Scaling Up Early Childhood Development in Zambia

Boston University3 sites in 1 country1,108 target enrollmentSeptember 20, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Early Childhood Development
Sponsor
Boston University
Enrollment
1108
Locations
3
Primary Endpoint
Caregiver Reported Early Development Index
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

In Zambia, 40% of children under five years of age are stunted and 6% are wasted. While the Zambian government has focused on child nutrition in recent years, more focus on holistically improving early child development (ECD) is needed. Through a previous randomized controlled trial, the investigators developed a community-based parenting intervention and demonstrated that this intervention can improve children's developmental outcomes in Zambia, including nutritional status and their early language development. During fortnightly group meetings, parents learn a diverse curriculum that includes content on: 1) cognitive stimulation and play practices; 2) child nutrition and cooking practices; and 3) self-care for good mental health. This information and learning content is delivered by supervised community volunteers using an interactive theatre-based approach.

In this study, the newly established maternity waiting homes (MWHs) and affiliated Safe Motherhood Action Group leaders (SMAGs) will be used as a novel platform to launch and support community-based parenting groups, embedding this program directly into the existing health system, and making them more feasible for scale-up and sustainability.

Despite the positive impact of the proposed parenting-group model in the pilot trial, this model is not currently operating in Zambia. By integrating this intervention into the existing health system, large populations of rural children exposed to high levels of adversity in the critical early years of life could be reached in a nationally scalable fashion. As part of this project, the investigators propose to implement and rigorously assess the impact of this approach in four districts of Zambia.

Detailed Description

This research will utilize a cluster-randomized controlled trial with integrated mixed-methods process evaluation to understand the impact of parenting groups on child development outcomes when delivered at scale. The specific objectives are to: 1) assess the impact of the intervention on early childhood development outcomes; 2) assess the degree to which the intervention was implemented according to the project plan and to document adjustments made during the course of the project; 3) describe and document the perceptions of caregivers on parent groups, as well as any behavioral changes in parenting or in mother support networks resulting from participating in parenting groups; and approaches to achieving caregiving gender equality at household level; and, 4) generate a set of recommendations for the Government of the Republic of Zambia to further adapt and/or scale up community parenting groups based on the summative findings from this study. For the impact evaluation the investigators will collect data from two main sources: 1) Household Surveys and 2) In-depth interviews at both baseline and endline data collection. In addition, at endline we will assess child development using the Malawi Developmental Assessment Tool (MDAT). For the process evaluation, the investigators will conduct record review of parenting groups attendance registers and SMAG log books. The investigators will conduct in-depth interviews with health systems staff (province, district and health facility), SMAGs, and head women from all intervention sites, and focus group discussions with caregivers who meet the study eligibility criteria in both intervention and control zones.

Registry
clinicaltrials.gov
Start Date
September 20, 2019
End Date
January 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children aged 0-5 months at baseline in the catchment areas of the ten selected health facilities in Southern and Eastern Provinces will be eligible to participate
  • Child's primary caregiver must be 15 years or older
  • Child's primary caregiver must be a female (because the participants in the women's group 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 period of the study
  • In-depth interviews (IDI)
  • Inclusion Criteria:
  • A member of the health facility staff at a study site for at least 6 months; or
  • A district or provincial level health staff; or
  • A SMAG member at a study site who has been trained to implement the parenting group intervention; or
  • A 'head mother' leading parenting group sessions within their communities; and ≥18 years of age and provided informed consent to participate in the IDI.
  • Exclusion criteria
  • Focus group discussions (FGDs)

Outcomes

Primary Outcomes

Caregiver Reported Early Development Index

Time Frame: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months

Summary score of child development measures (motor, cognitive, language, and social emotional skills)

Child linear growth: Stunting

Time Frame: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months

Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard World Health Organization (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.

Child development z-scores based on Malawi Developmental Assessment Tool (MDAT)

Time Frame: At endline (child aged 24-29 months) children are assessed using the MDAT. Scores are standardized within the study sample for analysis.

Cognitive function measurements

Secondary Outcomes

  • Proportion of children receiving vitamin A supplementation(Baseline (child 0-5 months), Endline (child aged 24-29 months))
  • Average time spent playing with the child(Baseline (child 0-5 months), Endline (child aged 24-29 months))
  • Number of well-baby visits attended(Baseline (child 0-5 months), Endline (child aged 24-29 months))
  • Proportion of children receiving all age-appropriate vaccines(Baseline (child 0-5 months), Endline (child aged 24-29 months))
  • Average time spent reading with the child(Baseline (child 0-5 months), Endline (child aged 24-29 months))

Study Sites (3)

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