Early Childhood Development Clinical Trial
— SUpErCDZOfficial title:
Evaluation of Scaling Up Early Childhood Development in Zambia
Verified date | August 2023 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1108 |
Est. completion date | January 31, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 0 Months and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Zambia | Choma District Medical Office | Choma | Southern |
Zambia | Kalomo District Medical Office | Kalomo | Southern |
Zambia | Nyimba District Medical Office | Nyimba | Eastern |
Lead Sponsor | Collaborator |
---|---|
Boston University | Grand Challenges Canada, Right to Care Zambia (RTCZ), Swiss Tropical & Public Health Institute, United States Agency for International Development (USAID) |
Zambia,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Child diet diversity | Caregivers will be asked about child feeding habits and dietary diversity | Baseline (child 0-5 months), Endline (child aged 24-29 months) | |
Other | Caregiver mental health based on the Self Reporting Questionnaire 20-item (SRQ-20) | 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) | |
Primary | Child linear growth: Stunting | 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 | |
Primary | Child development z-scores based on Malawi Developmental Assessment Tool (MDAT) | 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. | |
Primary | Caregiver Reported Early Development Index | 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 | Proportion of children receiving all age-appropriate vaccines | 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) | |
Secondary | Proportion of children receiving vitamin A supplementation | 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) | |
Secondary | Number of well-baby visits attended | 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) | |
Secondary | Average time spent reading with the child | 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) | |
Secondary | Average time spent playing with the child | 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) |
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