Evaluation of Scaling Up Early Childhood Development in Zambia (SUpErCDZ)

August 14, 2023 updated by: Boston University

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

1108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Eastern
      • Nyimba, Eastern, Zambia
        • Nyimba District Medical Office
    • Southern
      • Choma, Southern, Zambia
        • Choma District Medical Office
      • Kalomo, Southern, Zambia
        • Kalomo District Medical Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Exclusion criteria

-None

Focus group discussions (FGDs)

Inclusion Criteria:

  • A woman or a man with child under 3 years of age; or
  • Community health volunteers [SMAG, community health worker (CHW) or TBA]; and
  • Resident within the project zones; and -≥18 years of age

Exclusion Criteria:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community-based parenting group
The community-based parenting group will include 39 health zones and 585 caregiver-child dyads
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
Each of the 50 trained SMAGs will train 10 head women on the ECD curriculum
Every two weeks 500 trained head women lead parent group meetings on childhood development and nutrition to caregiver-child dyads
Active Comparator: Control group
The control group will include 39 health zones and 585 caregiver-child dyads
The traditional care and education of caregivers/parents for children 0-5 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months
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
At endline (child aged 24-29 months) children are assessed using the MDAT. Scores are standardized within the study sample for analysis.
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)
Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child diet diversity
Time Frame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Caregivers will be asked about child feeding habits and dietary diversity
Baseline (child 0-5 months), Endline (child aged 24-29 months)
Caregiver mental health based on the Self Reporting Questionnaire 20-item (SRQ-20)
Time Frame: 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
Baseline (child 0-5 months), Endline (child aged 24-29 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nancy A Scott, DrPH MPH, Boston University
  • Principal Investigator: Thandiwe Ngoma, Right to Care - Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • H-38950
  • TTS-1802-21377 (Other Grant/Funding Number: Grand Challenges Canada)
  • 72061119FA00001 (Other Grant/Funding Number: United States Agency for International Development (USAID))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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