Evaluation of Scaling Up Early Childhood Development in Zambia

NCT03991182 | Completed

• 3 other identifiers: H-38950TTS-1802-2137772061119FA00001
• Study Type: interventional
• Target: 1,108
• Locations: 1 country
• Sites: 3

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.

Conditions

Early Childhood Development

Keywords

Community based parenting; Developmental outcomes; Maternity waiting homes (MWHs); Safe Motherhood Action Group leaders (SMAGs); Zambia

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

• 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 Outcomes (5)

• Proportion of children receiving all age-appropriate vaccines

  Baseline (child 0-5 months), Endline (child aged 24-29 months)

• Proportion of children receiving vitamin A supplementation

  Baseline (child 0-5 months), Endline (child aged 24-29 months)

• Number of well-baby visits attended

  Baseline (child 0-5 months), Endline (child aged 24-29 months)

• Average time spent reading with the child

  Baseline (child 0-5 months), Endline (child aged 24-29 months)

• Average time spent playing with the child

  Baseline (child 0-5 months), Endline (child aged 24-29 months)

Other Outcomes (2)

• Child diet diversity

  Baseline (child 0-5 months), Endline (child aged 24-29 months)

• Caregiver mental health based on the Self Reporting Questionnaire 20-item (SRQ-20)

  Baseline (child 0-5 months), Endline (child aged 24-29 months)

Study Arms (2)

Community-based parenting group

EXPERIMENTAL

The community-based parenting group will include 39 health zones and 585 caregiver-child dyads

Other: SMAGs trained on ECD curriculum; Other: Head women trained on ECD curriculum; Behavioral: Head women led parent groups

Control group

ACTIVE COMPARATOR

The control group will include 39 health zones and 585 caregiver-child dyads

Other: Usual care of children 0-5 months

Interventions

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

Community-based parenting group

Head women trained on ECD curriculum OTHER

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

Community-based parenting group

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

Community-based parenting group

Usual care of children 0-5 months OTHER

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

Control group

Eligibility Criteria

• Age: 0 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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.
• None
• Focus group discussions (FGDs)
• 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
• None

Sponsors & Collaborators

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

Study Sites (3)

Nyimba District Medical Office

Nyimba, Eastern Province, Zambia

Location

Choma District Medical Office

Choma, Southern Province, Zambia

Location

Kalomo District Medical Office

Kalomo, Southern Province, Zambia

Location

Related Publications (3)

• 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.

  PMID: 29689045 BACKGROUND

• 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.

  PMID: 28588962 BACKGROUND

• 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.

  PMID: 30099401 BACKGROUND

Study Officials

• Nancy A Scott, DrPH MPH

  Boston University

  PRINCIPAL INVESTIGATOR

• Thandiwe Ngoma

  Right to Care - Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 19, 2019
• Study Start: September 20, 2019
• Primary Completion: November 30, 2021
• Study Completion: January 31, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (3)