NCT05405400

Brief Summary

The Early Childhood version of Sugira Muryango is a family-based, home-visiting intervention targeted at early childhood development and implemented with families living in extreme poverty in three districts of Rwanda. This version of Sugira Muryango was first tested in two small pilot studies and a large cluster randomized trial (CRT) was implemented between February 2018 and September 2019 . Pre- to post-intervention findings demonstrated that Sugira Muryango led to improvements in caregiver behaviors linked to child development and health as well as reductions in violence, which were sustained 12 months after the intervention, at which time improvements in child development were observed. The Research Program on Children and Adversity in the Boston College School of Social Work is led by Dr. Theresa S. Betancourt and will, in partnership with the University of Rwanda, FXB-Rwanda and Laterite, conduct a longitudinal follow-up study to investigate the longer-term outcomes of the Sugira Muryango intervention in families who participated in the CRT. The four-year follow-up will examine the long-term and sustained outcomes of the intervention. In particular, the investigators will look at key indicators of long-term positive outcomes for children such as school readiness and transition to formal schooling. Given the lack of longitudinal research on intervention programs supporting ECD in sub-Saharan Africa, this study will contribute greatly to the body of knowledge on the costs and benefits of investments in ECD and guide policy makers and government leaders on making impactful investments in children, leading to long-term benefits for the population at large. The follow-up study involves two activities: Activity A: Pilot to assess measures performance of newly added measures and field test study protocols. Activity B: Four-year follow-up of families who participated in the CRT of the Sugira Muryango intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,932

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

April 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

May 27, 2022

Last Update Submit

August 1, 2025

Conditions

Keywords

Early childhood developmentIntimate partner violenceRwandaInterventionLongitudinal

Outcome Measures

Primary Outcomes (10)

  • "Home Observation Measurement of the Environment" infants/toddlers survey and early childhood survey

    Observation of caregiver engagement and stimulation of children (younger siblings and CRT children)

    Through study completion (4 years)

  • "Ages & Stages Questionnaire - 3"

    Caregiver report on child's development (younger siblings)

    Through study completion (4 years)

  • "Mullen Scale of Early Learning"

    Observation of child's cognitive, motor, and linguistic development (younger siblings)

    Through study completion (4 years)

  • "Kaufman Assessment Battery for Children-2"

    Observation of child's cognitive and linguistic development (CRT children and older siblings)

    Through study completion (4 years)

  • "Wechsler Preschool & Primary Scale of Intelligence"

    Observation of child's cognitive and linguistic development

    Through study completion (4 years)

  • "International Development & Early Learning Assessment" stimulating care and play module

    Caregiver report on playful parenting activities and childcare arrangement (for all children)

    Through study completion (4 years)

  • "Multiple Indicator Cluster Survey" child discipline module

    Caregiver self-report of child discipline practices and behaviors (for all children)

    Through study completion (4 years)

  • Combined module based on "Multiple Indicator Cluster Survey" and "ISPCAN Child Abuse Screening Tool"

    Child self-report of experiences of discipline and violence (older siblings)

    Through study completion (4 years)

  • DHS "Intimate Partner Violence" survey

    Caregiver self-report on victimization and perpetration of intimate partner violence

    Through study completion (4 years)

  • "Child Behavior Checklist"

    Caregiver report on child's internalizing and/or externalizing (CRT children and older siblings)

    Through study completion (4 years)

Secondary Outcomes (22)

  • "Observation of Mother-Child Interactions"

    Through study completion (4 years)

  • "The Role of Play in Children's Learning"

    Through study completion (4 years)

  • "Parental Acceptance-Rejection Questionnaire"

    Through study completion (4 years)

  • DHS/Promundo "Father Engagement & Financial Decision-Making" survey

    Through study completion (4 years)

  • "Gender Equitable Men" scale

    Through study completion (4 years)

  • +17 more secondary outcomes

Other Outcomes (7)

  • "International Development & Early Learning Assessment" parent attitudes module

    Through study completion (4 years)

  • "International Development & Early Learning Assessment" parent expectations module

    Through study completion (4 years)

  • Epstein survey

    Through study completion (4 years)

  • +4 more other outcomes

Study Arms (2)

Treatment group

Families in the treatment group received one welcome visit, 12 visits from a community-based volunteer trained in the Sugira Muryango intervention over 3-4 months, as well as booster visits at 3 and 6 months. The primary caregiver, secondary caregiver if applicable, and any children ages 6-36 months participated in the sessions. Other family members were welcome to join as available.

Control group

Usual childcare (no intervention)

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population consists of families who participated in the earlier CRT. Families for the CRT were randomly selected from government-provided lists of families who were eligible for the Vision Umurenge Program (VUP). Families' participation in the VUP and selection into one of two versions of the VUP program, namely classic public works (cPW) or expanded public works (ePW), was determined by governmental policies and was not under the control of the research team. Eligibility for VUP indicates that the family was in the poorest category under Rwanda's poverty categorization system (Ubudehe 1). Families were living in Ngoma, Nyanza or Rubavu district of Rwanda and had at least one child between the ages of 6-36 months.

You may qualify if:

  • living in the Rubavu, Ngoma or Nyanza District of Rwanda
  • being VUP-eligible (according to the Rwandan government)
  • having at least one child aged 6-36 months living in the home
  • having at least one caregiver who was willing to discuss and enhance their caregiving practices by interacting with a home-visiting coach (a community-based volunteer or CBV).
  • was aged 18 or older and cared for child(ren)
  • having participated in the prior CRT
  • living in Ngoma, Nyanza, or Rubavu districts
  • having at least one child who participated in the CRT and who is currently living in the household.
  • aged 3 months or older
  • was not eligible to participate in the original CRT due to age (below 6 months or not yet born at the time of CRT).
  • aged 12 years or younger
  • lived in the household but was not eligible to participate in the original CRT due to age (above 36 months at the time of CRT)
  • currently lives in the household that participated in the CRT.

You may not qualify if:

  • caregiver(s) having severe cognitive impairments which precluded their ability to speak to the research questions under study
  • families or caregivers being in the midst of crisis (e.g., a caregiver(s) with active suicidal attempts or psychosis). Families with ongoing crises or disabilities were excluded from the study and were referred to appropriate services.
  • Siblings will be excluded from sampling for the spillover study if the primary caregiver has been away from the household for six months or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Homes and community buildings

Ngoma, Rwanda

Location

Homes and community buildings

Nyanza, Rwanda

Location

Homes and community buildings

Rubavu, Rwanda

Location

Related Publications (5)

  • Barnhart, D. A., Farrar, J., Murray, S. M., Brennan, R. T., Antonaccio, C., Sezibera, V., Ingabire, C., Godfroid, K., Bazubagira, S., Uwimana, O., Kamurase, A., Yousafzai, A., Betancourt, T. (2020). Lay-worker delivered home promotes early childhood development and reduces violence in Rwanda; a randomized pilot. Journal of Child and Family Studies; 29, 1804-1817. https://doi.org/10.1007/s10826-020-01709-1

    BACKGROUND
  • Betancourt, T. S., Franchett, E., Kirk, C. M., Brennan, R. T., Rawlings, L., Wilson, B., ... & Ukundineza, C. (2018). Integrating social protection and early childhood development: open trial of a family home-visiting intervention, Sugira Muryango. Early Child Development and Care; 190(2), 219-235.

    BACKGROUND
  • Betancourt TS, Jensen SKG, Barnhart DA, Brennan RT, Murray SM, Yousafzai AK, Farrar J, Godfroid K, Bazubagira SM, Rawlings LB, Wilson B, Sezibera V, Kamurase A. Promoting parent-child relationships and preventing violence via home-visiting: a pre-post cluster randomised trial among Rwandan families linked to social protection programmes. BMC Public Health. 2020 May 6;20(1):621. doi: 10.1186/s12889-020-08693-7.

    PMID: 32375840BACKGROUND
  • Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4.

    PMID: 27717615BACKGROUND
  • Jensen SK, Placencio-Castro M, Murray SM, Brennan RT, Goshev S, Farrar J, Yousafzai A, Rawlings LB, Wilson B, Habyarimana E, Sezibera V, Betancourt TS. Effect of a home-visiting parenting program to promote early childhood development and prevent violence: a cluster-randomized trial in Rwanda. BMJ Glob Health. 2021 Jan;6(1):e003508. doi: 10.1136/bmjgh-2020-003508.

    PMID: 33514591BACKGROUND

MeSH Terms

Conditions

Growth DisordersLanguageDepressionBehavior

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCommunicationBehavioral Symptoms

Study Officials

  • Theresa S Betancourt, ScD, MA

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Salem Professor in Global Practice

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 6, 2022

Study Start

April 20, 2022

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations