NCT03045640

Brief Summary

Study activities were carried out to adapt and test a family-strengthening intervention to improve child development outcomes among families facing adversity in Rwanda.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

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

October 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

December 16, 2016

Last Update Submit

May 30, 2018

Conditions

Child Development

Keywords

ECDparenting programhome visiting

Outcome Measures

Primary Outcomes (1)

  • Change: Ages and Stages Questionnaire

    Child development

    12 months/18 months

Secondary Outcomes (4)

  • Change: Hopkins Symptoms CheckList

    12 months/18 months

  • Change: MICS-5

    12 months/18 months

  • Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey

    12 months/18 months

  • Change: Locally Derived Scale

    12 months/18 months

Study Arms (1)

FSI ECD

EXPERIMENTAL

Vulnerable Households (ubudehe 1 or 2) in the Government of Rwanda's poverty classification system, when categories ranged from 1 to 6; the system has since been restructured to have four categories only. Often a way to identify households for public works opportunities or other government assistance programs. For this arm, families had to be Ubudehe 1 or 2 and have a child aged 0-3 years. Households meeting these criteria in the catchment area(s) received the FSI ECD home-based parenting intervention from bachelor-level interventionists/"coaches."

Other: FSI ECD

Interventions

FSI ECDOTHER

The FSI ECD intervention was delivered in a structured curriculum format, covering a range of topics from health, water and sanitation, good hygiene, early stimulation, conflict resolution, to good communication. It was designed to improve vulnerable households home environment and engagement with their children in order to improve child development outcomes. The curriculum was delivered by bachelor-level trained staff with beneficiaries on an individual, one on one basis, using active coaching to promote child well being and behaviors with caregivers.

Also known as: Family Strengthening Intervention for ECD
FSI ECD

Eligibility Criteria

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

You may qualify if:

  • Potential participants must live in the study catchment area
  • Caregiver(s) raising a child between 6 and 3 years old and Ubudehe 1 or 2 (Rwanda's poverty classification system)
  • We will enroll both single and dual caregiver families to reflect population dynamics.
  • Legal guardians may be aunts, uncles, grandparents, or foster parents

You may not qualify if:

  • Potential participants that do not live in the study catchment area
  • Do not have at least one child between the ages of 0 and 3 living in their household for whom they are the primary caregiver
  • Are not classified as Ubudehe 1 or 2
  • Have severe cognitive impairments which preclude their ability to speak to the research questions under study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Desrosiers A, Saran I, Albanese AM, Antonaccio CM, Neville SE, Esliker R, Jambai M, Feika M, Betancourt TS. Task-sharing to promote caregiver mental health, positive parenting practices, and violence prevention in vulnerable families in Sierra Leone: a pilot feasibility study. BMC Psychiatry. 2024 Nov 11;24(1):787. doi: 10.1186/s12888-024-06209-w.

    PMID: 39529061DERIVED

Study Officials

  • Theresa Betancourt, Sc.D, M.A.

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 16, 2016

First Posted

February 7, 2017

Study Start

October 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 31, 2018

Record last verified: 2018-05