Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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, CHW or TBA); and - Resident within the project zones; and -≥18 years of age Exclusion Criteria: -None

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Community-based parenting group
The community-based parenting group will include 39 health zones and 585 caregiver-child dyads
  • Other: SMAGs 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
  • Other: Head women trained on ECD curriculum
    Each of the 50 trained SMAGs will train 10 head women on the ECD curriculum
  • Behavioral: Head women led parent groups
    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
  • Other: Usual care of children 0-5 months
    The traditional care and education of caregivers/parents for children 0-5 months

More Details

Status
Recruiting
Sponsor
Boston University

Study Contact

Nancy A Scott, DrPH MPH
617 358 2184
nscott@bu.edu

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 Bayley Scales for Infant and Toddler Development, Third Edition (BSID-III). 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.