ClinicalTrials.gg
CompletedNCT05405400Updated Aug 6, 2025

The Sugira Muryango Longitudinal & Spillover Study

An observational study in Cognitive Change, Growth; Stunting, Nutritional and Language, sponsored by Boston College. Completed at 3 sites in Rwanda. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-06.

Sponsored by Boston College · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,932
Ages
3 Months and older
Sex
All
01

Study 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.

Read the detailed description

The aim of the study is to assess the impacts of Sugira Muryango on treated families compared to families receiving only usual care (controls) four years after the intervention. Moreover, at this visit, the investigators will also for the first time examine potential spillover effects of Sugira Muryango onto siblings of children enrolled in the original study. The longitudinal follow-up study will assess whether and to what extent Sugira Muryango has an impact on caregivers' awareness and utilization of available services; support for children's education and playful learning; home hygiene; parenting practices, including child feeding/nutrition, stimulation and sensitive care; experiences of intimate partner violence; use of harsh discipline; mental health, including depression and alcohol use; gender attitudes; and overall wellbeing. It will also assess whether and to what extent Sugira Muryango has an impact on children's physical development; cognitive and linguistic development; temperament; enrollment in early or formal education; school readiness, including self-regulation and early literacy and numeracy; mental health, including internalizing and externalizing and depression; behavior, including conduct problems; and gender attitudes. Finally, the study will assess potential covariates such as the impact of the COVID-19 pandemic and associated lockdowns, child disability, and household size and composition.

The specific objectives are:

To assess the long-term (4 years post-intervention) impact of Sugira Muryango on caregiver behaviors, attitudes, mental health and wellbeing, especially as related to parenting and intimate partner violence.

To assess the long-term (4 years post-intervention) impact of Sugira Muryango on previously enrolled children's physical and cognitive development and health.

To assess the long-term (4 years post-intervention) impact of Sugira Muryango on previously enrolled children's behavior, mental health, school readiness and gender attitudes.

To assess the long-term (4 years post-intervention) impact of Sugira Muryango on younger and older siblings of children enrolled in the intervention, including on their physical and cognitive development and health, and in the case of older siblings their school readiness, behavior and gender attitudes.

The following activities will be conducted during the proposed 4-year follow up study:

  • Activity A: Pilot to assess measures performance and field test study protocols.

    • Phase A1: Translation and adaptation of newly selected measures.
    • Phase A2: A Pilot study of selected new child measures with 150 children and their primary caregivers in a sector of the Sugira Muryango PLAY Collaborative Expansion Study to test the feasibility and validity of new tools.
  • Activity B: Four-year follow-up of families who participated in the Cluster Randomized Trial (CRT) of the Sugira Muryango intervention.

    • Phase B1: Household tracking and re-enrollment of 1,049 households that participated in the prior CRT (April-May 2022).
    • Phase B2: Quantitative (full sample) and qualitative (subsample) data collection with the 1,049 households from the prior CRT, including children and caregivers who were in the original CRT, and siblings in a subset of households to test for spillover effects (June [Quantitative] \& December [Qualitative] 2022).

Our specific hypotheses are as follows:

Longitudinal Hypotheses

  1. Sugira Muryango will have effects (superior when compared to usual care households) on a range of outcome domains, both new domains and those assessed in the prior CRT.

    1. Sugira Muryango will continue to have effects among eligible caregivers and children compared to controls on a range of outcomes assessed at previous waves of data collection, and
    2. Sugira Muryango will have effects on new outcomes that have become relevant as the children have aged, including aspects of school readiness.

    Spillover Hypothesis

  2. Sugira Muryango will have positive effects on younger and older siblings of children who were eligible for and participated in the intervention compared to siblings in usual care households.

Secondary exploratory analyses Analyses evaluating potential child and caregiver sex differences will be performed across all outcomes to examine differences in parenting behaviors and child outcomes as children get older and approach school age.

Study benefits and justification Potential societal benefits of the study include increased knowledge about evaluating ECD and parenting in Rwanda, increased knowledge of ECD in Rwanda, and increased knowledge regarding family-based ECD interventions to improve child development outcomes in low-resource settings. Intervening in early childhood has been demonstrated to be highly cost-effective for improving child development and life outcomes, yet interventions in low-resource settings-particularly in sub-Saharan Africa-are limited and not always well-evaluated or systematically implemented. At the individual level, families who participate in the study will receive free disability and behavioral screening for eligible children and will be connected with support services should a disability or other risk of harm be identified.

The key research question is whether Sugira Muryango provides lasting benefits to children in households that received the intervention. Little longitudinal research into home-visiting ECD interventions in this region exists; findings from the proposed research will add critical evidence to inform Rwanda's expansion of ECD support to families as well as learnings for other countries.

The study has been reviewed and approved by the Rwanda National Ethics Committee, the National Institute of Statistics of Rwanda, and the National Council for Science and Technology in Rwanda.

02

Conditions studied

  • Cognitive Change
  • Growth; Stunting, Nutritional
  • Language
  • Depression
  • Behavior
  • Violence
  • Parenting

Keywords

  • Early childhood development
  • Intimate partner violence
  • Rwanda
  • Intervention
  • Longitudinal
03

In context

Growth Disorders

227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.

This study's enrollment of 2,932 is above the median of 231 across 78 observational studies indexed under Growth Disorders.

Browse Growth Disorders studies →

Lead sponsor

Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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.

Eligibility criteria

Participated in the Sugira Muryango CRT in 2018-19 (Trial Registration Number NCT02510313).

Family inclusion criteria for the CRT were:

  • 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).

Further caregiver inclusion criteria were:

  • was aged 18 or older and cared for child(ren)
  • lived in the same household as the child(ren). For the current Longitudinal Study, inclusion criteria for families are
  • 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.

Inclusion criteria for younger siblings are:

  • 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).

Inclusion criteria for older siblings are:

  • 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.

Exclusion Criteria:

Other than not meeting inclusion criteria, specific family exclusion criteria for the CRT were:

  • 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.
  • These exclusion criteria remain the same for the current Longitudinal study.
  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,932 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. "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)

    Time frame: Through study completion (4 years)

  2. "Ages & Stages Questionnaire - 3"

    Caregiver report on child's development (younger siblings)

    Time frame: Through study completion (4 years)

  3. "Mullen Scale of Early Learning"

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

    Time frame: Through study completion (4 years)

  4. "Kaufman Assessment Battery for Children-2"

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

    Time frame: Through study completion (4 years)

  5. "Wechsler Preschool & Primary Scale of Intelligence"

    Observation of child's cognitive and linguistic development

    Time frame: Through study completion (4 years)

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

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

    Time frame: Through study completion (4 years)

  7. "Multiple Indicator Cluster Survey" child discipline module

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

    Time frame: Through study completion (4 years)

  8. 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)

    Time frame: Through study completion (4 years)

  9. DHS "Intimate Partner Violence" survey

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

    Time frame: Through study completion (4 years)

  10. "Child Behavior Checklist"

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

    Time frame: Through study completion (4 years)

Secondary outcomes

  1. "Observation of Mother-Child Interactions"

    Observation of caregiver's sensitive care (younger siblings)

    Time frame: Through study completion (4 years)

  2. "The Role of Play in Children's Learning"

    Caregiver self-report on play for children's learning and development

    Time frame: Through study completion (4 years)

  3. "Parental Acceptance-Rejection Questionnaire"

    Caregiver self-report of stimulating care and play

    Time frame: Through study completion (4 years)

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

    Caregiver self-report of financial decision making and father engagement in the family

    Time frame: Through study completion (4 years)

  5. "Gender Equitable Men" scale

    Caregiver self-report of views of gender and masculinity

    Time frame: Through study completion (4 years)

  6. "Multiple Indicator Cluster Survey (5)" WASH module

    Caregiver self-report of home sanitation \& hygiene

    Time frame: Through study completion (4 years)

  7. World Health Organization "Infant and Young Child Feeding Practices" survey

    Caregiver self-report of feeding practices

    Time frame: Through study completion (4 years)

  8. "Hopkins Symptom Checklist (25)"

    Diagnostic tool for depression and anxiety in caregivers

    Time frame: Through study completion (4 years)

  9. "Enrollment in early education" survey

    Caregiver report of child's enrollment in early education

    Time frame: Through study completion (4 years)

  10. "Child Enrollment in Formal Education" survey

    Caregiver report of child's enrollment in formal education

    Time frame: Through study completion (4 years)

  11. "Service utilization" survey

    Caregiver self-report on services utilized, e.g. government and non-governmental inputs and services

    Time frame: Through study completion (4 years)

  12. Anthropometric measures: height in centimeters

    Measure of child height in centimeters (younger siblings and CRT children)

    Time frame: Through study completion (4 years)

  13. "Preschool Self-Regulation Assessment"

    Caregiver report of child's self-regulation (CRT children)

    Time frame: Through study completion (4 years)

  14. "Infant Behavior Questionnaire"

    Caregiver report of child's temperament (younger siblings)

    Time frame: Through study completion (4 years)

  15. "Early Childhood Behavior Questionnaire"

    Caregiver report of child's temperament (younger siblings)

    Time frame: Through study completion (4 years)

  16. "Early Grade Reading Assessment"

    Assessment of early literacy skills in children (older siblings)

    Time frame: Through study completion (4 years)

  17. "Center for Epidemiological Studies Depression Scale"

    Diagnostic tool for depression in children (older siblings)

    Time frame: Through study completion (4 years)

  18. "Gender Equitable Men" scale

    Child self-report of views of gender and masculinity (older siblings)

    Time frame: Through study completion (4 years)

  19. Anthropometric measures: weight in kilograms

    Measure of child weight in kilograms (younger siblings and CRT children)

    Time frame: Through study completion (4 years)

  20. Anthropometric measures: standardized height-for-weight

    Height and weight will be combined and the resulting scores standardized and reported as z-scores (younger siblings and CRT children)

    Time frame: Through study completion (4 years)

  21. Anthropometric measures: standardized height-for-age

    Height and age will be combined and the resulting scores standardized and reported as z-scores (younger siblings and CRT children)

    Time frame: Through study completion (4 years)

  22. Anthropometric measures: middle upper arm circumference in centimeters

    Measure of child circumference of middle upper arm in centimeters (younger siblings and CRT children)

    Time frame: Through study completion (4 years)

Other outcomes

  1. "International Development & Early Learning Assessment" parent attitudes module

    Caregiver self-report of attitudes towards children's education

    Time frame: Through study completion (4 years)

  2. "International Development & Early Learning Assessment" parent expectations module

    Caregiver self-report of expectations towards children's education

    Time frame: Through study completion (4 years)

  3. Epstein survey

    Caregiver self-report of support for children's education

    Time frame: Through study completion (4 years)

  4. World Health Organization "Alcohol Use Disorders Identification Test (AUDIT)"

    Caregiver self-report of alcohol use and/or abuse

    Time frame: Through study completion (4 years)

  5. "Flourishing Scale"

    Caregiver self-report on quality of life

    Time frame: Through study completion (4 years)

  6. "Gender Equitable Men" norms scale

    Caregiver self-report of perceived norms related to gender and masculinity

    Time frame: Through study completion (4 years)

  7. "Youth Conduct Problems Scale - Rwanda"

    Child self-report of conduct problems (older siblings)

    Time frame: Through study completion (4 years)

07

Study locations

3 sites
  • Homes and community buildings
    Ngoma, Rwanda
  • Homes and community buildings
    Nyanza, Rwanda
  • Homes and community buildings
    Rubavu, Rwanda
08

References and documents

Publications

  • 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
  • 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.
  • 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. PubMed 32375840 ↗
  • 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. PubMed 27717615 ↗
  • 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. PubMed 33514591 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Jun 2022, 2 months.

Of 42 observational studies under Growth Disorders, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 55. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2022
First posted
Jun 6, 2022
StartActual
Apr 20, 2022
Primary completionActual
Jun 30, 2022
CompletionActual
Dec 31, 2022
Last update
Aug 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05405400
Lead sponsor
Boston College
Collaborators
University of Rwanda, FXB-Rwanda, LEGO Foundation, The ELMA Foundation, Echidna Giving, Wellspring Philanthropic Fund, United States Agency for International Development (USAID)
Responsible party
Theresa Betancourt (Salem Professor in Global Practice, Boston College) — Principal investigator
First posted
Jun 6, 2022
Start date
Apr 20, 2022
Primary completion
Jun 30, 2022
Completion
Dec 31, 2022
Last update
Aug 6, 2025

Study contacts

Theresa S Betancourt, ScD, MA
principal investigator · Boston College

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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