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Completed

NCT Number: NCT03991182

Evaluation of Scaling Up Early Childhood Development in Zambia

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.

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Key information

Age range

0 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nyimba District Medical Office, Nyimba, Eastern Province, Zambia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMAGs trained on ECD curriculum

Other

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

Head women trained on ECD curriculum

Other

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

Head women led parent groups

Behavioral

Every two weeks 500 trained head women lead parent group meetings on childhood development and nutrition to caregiver-child dyads

Usual care of children 0-5 months

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Grand Challenges Canada
  • Right to Care Zambia (RTCZ)
  • Swiss Tropical & Public Health Institute
  • United States Agency for International Development (USAID)

Registry information

Acronym: SUpErCDZ

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 19, 2019
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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