Evaluation of Scaling Up Early Childhood Development in Zambia
NCT ID: NCT03991182
Last Updated: 2023-08-16
Study Results
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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COMPLETED
NA
1108 participants
INTERVENTIONAL
2019-09-20
2022-01-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
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
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
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
Control group
The control group will include 39 health zones and 585 caregiver-child dyads
Usual care of children 0-5 months
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
Head women trained on ECD curriculum
Each of the 50 trained SMAGs will train 10 head women on the ECD curriculum
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
Usual care of children 0-5 months
The traditional care and education of caregivers/parents for children 0-5 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Months
ALL
Yes
Sponsors
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Right to Care Zambia (RTCZ)
UNKNOWN
Swiss Tropical & Public Health Institute
OTHER
United States Agency for International Development (USAID)
FED
Grand Challenges Canada
OTHER
Boston University
OTHER
Responsible Party
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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
Choma District Medical Office
Choma, Southern Province, Zambia
Kalomo District Medical Office
Kalomo, Southern Province, Zambia
Countries
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
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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