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Evaluation of Scaling Up Early Childhood Development in Zambia

Evaluation of Scaling Up Early Childhood Development in Zambia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03991182
Acronym
SUpErCDZ
Enrollment
1108
Registered
2019-06-19
Start date
2019-09-20
Completion date
2022-01-31
Last updated
2023-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Development

Keywords

Community based parenting, Developmental outcomes, Maternity waiting homes (MWHs), Safe Motherhood Action Group leaders (SMAGs), Zambia

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.

Interventions

OTHERSMAGs trained on ECD curriculum

50 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 curriculum

Each of the 50 trained SMAGs will train 10 head women on the ECD curriculum

BEHAVIORALHead women led parent groups

Every 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 months

The traditional care and education of caregivers/parents for children 0-5 months

Sponsors

Right to Care Zambia (RTCZ)
CollaboratorUNKNOWN
Swiss Tropical & Public Health Institute
CollaboratorOTHER
United States Agency for International Development (USAID)
CollaboratorFED
Grand Challenges Canada
CollaboratorOTHER
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

Caregiver-child dyads in the impact cohort 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.

Design outcomes

Primary

MeasureTime frameDescription
Child development z-scores based on Malawi Developmental Assessment Tool (MDAT)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
Caregiver Reported Early Development IndexChildren aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 monthsSummary score of child development measures (motor, cognitive, language, and social emotional skills)
Child linear growth: StuntingChildren aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 monthsHeights 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.

Secondary

MeasureTime frameDescription
Number of well-baby visits attendedBaseline (child 0-5 months), Endline (child aged 24-29 months)Caregivers will be asked about the health seeking behaviors for the child; results will be compared against government recommendations and against child development outcomes
Average time spent playing with the childBaseline (child 0-5 months), Endline (child aged 24-29 months)Caregivers will be asked about their engagement with the child and other adult engagement with the child at baseline and endline
Average time spent reading with the childBaseline (child 0-5 months), Endline (child aged 24-29 months)Caregivers will be asked about their engagement with the child and other adult engagement with the child at baseline and endline
Proportion of children receiving all age-appropriate vaccinesBaseline (child 0-5 months), Endline (child aged 24-29 months)We will collect data at baseline and endline on whether the study children are up to date on vaccines as recommended by the government vaccination schedule.
Proportion of children receiving vitamin A supplementationBaseline (child 0-5 months), Endline (child aged 24-29 months)Caregivers will be asked about vitamin A supplementation and responses will be compared to child development outcomes

Other

MeasureTime frameDescription
Child diet diversityBaseline (child 0-5 months), Endline (child aged 24-29 months)Caregivers will be asked about child feeding habits and dietary diversity
Caregiver mental health based on the Self Reporting Questionnaire 20-item (SRQ-20)Baseline (child 0-5 months), Endline (child aged 24-29 months)Caregivers will be asked a series of questions on their personal mental health using an instrument that has been adapted to the context

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026