Clinical Trials Directory

Trials / Completed

CompletedNCT03991182

Evaluation of Scaling Up Early Childhood Development in Zambia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,108 (actual)
Sponsor
Boston University · Academic / Other
Sex
All
Age
0 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSMAGs trained on ECD curriculum50 volunteers (primarily SMAGs- Safe Motherhood Action Group members) associated with the health facility will be trained using a training -of-trainers approach on the e ECD (early childhood development) curriculum
OTHERHead women trained on ECD curriculumEach of the 50 trained SMAGs will train 10 head women on the ECD curriculum
BEHAVIORALHead women led parent groupsEvery two weeks 500 trained head women lead parent group meetings on childhood development and nutrition to caregiver-child dyads
OTHERUsual care of children 0-5 monthsThe traditional care and education of caregivers/parents for children 0-5 months

Timeline

Start date
2019-09-20
Primary completion
2021-11-30
Completion
2022-01-31
First posted
2019-06-19
Last updated
2023-08-16

Locations

3 sites across 1 country: Zambia

Source: ClinicalTrials.gov record NCT03991182. Inclusion in this directory is not an endorsement.