Evaluation of Scaling Up Early Childhood Development in Zambia

Early Childhood Development Clinical Trial

— SUpErCDZ  

Official title:

Evaluation of Scaling Up Early Childhood Development in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991182
• Other study ID #: H-38950
• Secondary ID: TTS-1802-2137772
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2023
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Early Childhood Development

Intervention

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
• 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

Other:
• Usual care of children 0-5 months
The traditional care and education of caregivers/parents for children 0-5 months

Locations

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

Sponsors (5)

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)

Country where clinical trial is conducted

Zambia, 

References & Publications (3)

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

Outcome

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)