NCT02704000

Brief Summary

This study evaluates the efficacy and cost-effectiveness of two platforms for delivering home visiting programs in the poor urban setting of Sao Paulo's western region: a program delivered by a newly trained cadre of Child Development Agents, and a program delivered by Community Health Agents employed by the government as part of the Family Health Strategy (ESF). The program will randomly select 400 mother-child dyads to follow a curriculum that is currently being adapted to the local context. The primary outcome of the program will be cognitive development for children aged 9 to 15 months old at baseline (21-27 months at endline) The secondary outcomes will include child physical development as well as maternal mental health.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
826

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

February 24, 2016

Last Update Submit

November 27, 2023

Conditions

Child DevelopmentMental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

  • Child cognitive development as measured by Griffith Scales of Mental Development

    Overall cognitive development of children after 12 months of intervention.

    12 months after program initiation

Secondary Outcomes (3)

  • Maternal depression risk as assessed by the Edinburgh Scale

    12 months after program initiation

  • Child height relative to WHO reference curve (normalized z-score)

    12 months after program initiation

  • Child weight relative to WHO reference curve (normalized z-score)

    12 months after program initiation

Study Arms (3)

Control

NO INTERVENTION

No interventions - only baseline and endline assessments to be conducted at children's home.

Home visits by CDAs

EXPERIMENTAL

Intervention: Behavioral: Home visiting program (Jamaica curriculum) Children in this intervention arm will be visited twice a months by trained child development agents (CDAs). CDAs will implement the Jamaica curriculum intervention during the home visits..

Behavioral: Home visiting program (Jamaica curriculum)

Home visits by CHWs

EXPERIMENTAL

Intervention: Behavioral: Home visiting program (Jamaica curriculum) Children in this intervention arm will be visited twice a months by trained community health workers (CHWs) trained on delivering the intervention. CHWs will implement the Jamaica curriculum intervention during the home visits..

Behavioral: Home visiting program (Jamaica curriculum)

Interventions

Home visiting program (Jamaica curriculum)BEHAVIORAL

Agents will deliver bi-weekly home-visits following the curriculum developed for the Jamaica intervention study by Susan Walker and colleagues. This curriculum foresees age-appropriate tasks assigned to the caregiver during each visit.

Home visits by CDAsHome visits by CHWs

Eligibility Criteria

Age9 Months - 17 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • enrolled in Western Region Cohort study

You may not qualify if:

  • not enrolled in Western Region Cohort study
  • not in target age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Brentani A, Walker S, Chang-Lopez S, Grisi S, Powell C, Fink G. A home visit-based early childhood stimulation programme in Brazil-a randomized controlled trial. Health Policy Plan. 2021 Apr 21;36(3):288-297. doi: 10.1093/heapol/czaa195.

    PMID: 33496330RESULT

  • Smith JA, Baker-Henningham H, Brentani A, Mugweni R, Walker SP. Implementation of Reach Up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. Ann N Y Acad Sci. 2018 May;1419(1):120-140. doi: 10.1111/nyas.13678.

    PMID: 29791729RESULT

Study Officials

  • Alexandra VM Brentani, PhD

    Universidade de São Paulo, Faculdade de Medicina USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 9, 2016

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2019

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share