Evaluation of Scaling Up Early Childhood Development in Zambia

NCT ID: NCT03991182

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Early Childhood Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Community-based parenting group

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

Group Type EXPERIMENTAL

SMAGs trained on ECD curriculum

Intervention Type 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

Head women trained on ECD curriculum

Intervention Type OTHER

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

Head women led parent groups

Intervention Type BEHAVIORAL

Every two weeks 500 trained head women lead parent group meetings on childhood development and nutrition to caregiver-child dyads

Control group

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

Group Type ACTIVE_COMPARATOR

Usual care of children 0-5 months

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Head women trained on ECD curriculum

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

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

Usual care of children 0-5 months

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

Intervention Type OTHER

Eligibility Criteria

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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)


* 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.


* 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

* 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)


-None

Focus group discussions (FGDs)


-None
Minimum Eligible Age

0 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Right to Care Zambia (RTCZ)

UNKNOWN

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

Grand Challenges Canada

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy A Scott, DrPH MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Thandiwe Ngoma

Role: PRINCIPAL_INVESTIGATOR

Right to Care - Zambia

Locations

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Nyimba District Medical Office

Nyimba, Eastern Province, Zambia

Site Status

Choma District Medical Office

Choma, Southern Province, Zambia

Site Status

Kalomo District Medical Office

Kalomo, Southern Province, Zambia

Site Status

Countries

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Zambia

References

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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.

Reference Type BACKGROUND
PMID: 29689045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28588962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30099401 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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TTS-1802-21377

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

72061119FA00001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-38950

Identifier Type: -

Identifier Source: org_study_id

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