Clinical trial NCT03991182: Evaluation of Scaling Up Early Childhood Development in Zambia
Official title: Evaluation of Scaling Up Early Childhood Development in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Childhood Development
Keywords: Community based parenting
Developmental outcomes
Maternity waiting homes (MWHs)
Safe Motherhood Action Group leaders (SMAGs)
Zambia
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Right to Care Zambia (RTCZ)
name: Swiss Tropical & Public Health Institute
name: United States Agency for International Development (USAID)
name: Grand Challenges Canada
First posted: 2019-06-19
Enrollment: 1108
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

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

Primary outcomes:
measure: Child linear growth: Stunting
timeFrame: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months
measure: Child development z-scores based on Malawi Developmental Assessment Tool (MDAT)
timeFrame: At endline (child aged 24-29 months) children are assessed using the MDAT. Scores are standardized within the study sample for analysis.
measure: Caregiver Reported Early Development Index
timeFrame: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months
Secondary outcomes:
measure: Proportion of children receiving all age-appropriate vaccines
timeFrame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
measure: Proportion of children receiving vitamin A supplementation
timeFrame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
measure: Number of well-baby visits attended
timeFrame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
measure: Average time spent reading with the child
timeFrame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
measure: Average time spent playing with the child
timeFrame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Other outcomes:
measure: Child diet diversity
timeFrame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
measure: Caregiver mental health based on the Self Reporting Questionnaire 20-item (SRQ-20)
timeFrame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Locations:
city: Nyimba
country: Zambia
facility: Nyimba District Medical Office
state: Eastern
city: Choma
country: Zambia
facility: Choma District Medical Office
state: Southern
city: Kalomo
country: Zambia
facility: Kalomo District Medical Office
state: Southern
Study officials:
affiliation: Boston University
name: Nancy A Scott, DrPH MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Right to Care - Zambia
name: Thandiwe Ngoma
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rockers PC, Zanolini A, Banda B, Chipili MM, Hughes RC, Hamer DH, Fink G. Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial. PLoS Med. 2018 Apr 24;15(4):e1002555. doi: 10.1371/journal.pmed.1002555. eCollection 2018 Apr.
citation: Rockers PC, Fink G, Zanolini A, Banda B, Biemba G, Sullivan C, Mutembo S, Silavwe V, Hamer DH. Impact of a community-based package of interventions on child development in Zambia: a cluster-randomised controlled trial. BMJ Glob Health. 2016 Nov 22;1(3):e000104. doi: 10.1136/bmjgh-2016-000104. eCollection 2016.
citation: Scott NA, Kaiser JL, Vian T, Bonawitz R, Fong RM, Ngoma T, Biemba G, Boyd CJ, Lori JR, Hamer DH, Rockers PC. Impact of maternity waiting homes on facility delivery among remote households in Zambia: protocol for a quasiexperimental, mixed-methods study. BMJ Open. 2018 Aug 10;8(8):e022224. doi: 10.1136/bmjopen-2018-022224.