NCT03455127

Brief Summary

Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community based lay workers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

November 9, 2017

Last Update Submit

May 30, 2018

Conditions

Keywords

Child DevelopmentHome VisitingParenting ProgramSocial ProtectionPublic Works

Outcome Measures

Primary Outcomes (1)

  • Ages Stages Questionnaire-3

    Change in Child Communication, Fine Motor, Gross Motor, Problem Solving, and Personal Social Development

    12 months/18 months

Secondary Outcomes (10)

  • Hopkins Symptoms Check List

    12 months/18 months

  • Multiple Indicator Cluster Survey 5

    12 months/18 months

  • Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey

    12 months/18 months

  • Local Derived Scale

    12 months/18 months

  • System for Observing Family Therapy Alliances

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Classic Public Works as Usual

NO INTERVENTION

Half of the sample will be eligible to receive or be receiving the Government of Rwanda's (GOR) flagship social protection programming, Vision 2020 Program (VUP). One component of this program is to provide cash for work opportunities for labor endowed vulnerable households, i.e. one able bodied adult. Vulnerable households are those in Poverty Level 1 category, the GOR's poverty classification system. Furthermore, this study will require households in the control group receiving classic public works as usual to have at least one child between the ages of 6 months to 36 months.

Classic Public Works + FSI ECD

EXPERIMENTAL

Half of the sample will receive the FSI ECD home visiting parenting program alongside the GOR's classic public works programming. These households will be in Poverty Level 1 with an able-bodied adult, thus eligible to receive or be received the GORs public works programming. They will have a child between 6 and 36 months at enrollment. Households will be visited by a trained community based lay worker on a weekly to biweekly basis to deliver the 15 module curriculum covering a range of topics from nutrition, water and sanitation, hygiene, early stimulation, conflict management, to good communication. The intervention seeks to promote healthy child development via active coaching to individual beneficiary households, delivering modules on a one on one basis and engaging all family members.

Other: FSI ECD

Interventions

FSI ECDOTHER

Households will be visited by a trained community based lay worker on a weekly to biweekly basis to deliver the 15 module curriculum covering a range of topics from nutrition, water and sanitation, hygiene, early stimulation, conflict management, to good communication. The intervention seeks to promote healthy child development via active coaching to individual beneficiary households, delivering modules on a one on one basis and engaging all family members.

Also known as: Family Strengthening Intervention for ECD
Classic Public Works + FSI ECD

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rwamagana District

Rubona, Rwanda

Location

Study Officials

  • Theresa Betancourt, Sc.D., M.A.

    Boston College School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Salem Professor in Global Practice

Study Record Dates

First Submitted

November 9, 2017

First Posted

March 6, 2018

Study Start

March 10, 2017

Primary Completion

March 10, 2018

Study Completion

March 10, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations