Cognitive ChangeNCT05405400
The Sugira Muryango Longitudinal & Spillover Study
An observational study of Cognitive Change and Growth; Stunting, Nutritional, run by Boston College at 3 sites in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Growth; Stunting, Nutritional, Language
- How many people
- 2,932 participants
- Where
- 3 sitesRwanda
- Study dates
- 20 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Rwanda3 sites
Homes and community buildings
Ngoma
Homes and community buildings
Nyanza
Homes and community buildings
Rubavu
About this study
Official title: Understanding Longer-term Effects of a Father-engaged, Play-based Home Visiting Intervention to Promote Early Childhood Development and Prevent Violence in Rwanda: The Sugira Muryango Longitudinal & Spillover Study
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.
Read more
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
- 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.
- 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
- Sugira Muryango will have effects on new outcomes that have become relevant as the children have aged, including aspects of school readiness. Spillover Hypothesis
- 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.
- Conditions
- Cognitive Change, Growth; Stunting, Nutritional, Language, Depression, Behavior, Violence
- Keywords
- Early childhood development, Intimate partner violence, Rwanda, Intervention, Longitudinal
- Medical subject headings
- Growth Disorders, Language, Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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)
Measured: Through study completion (4 years)
"Ages & Stages Questionnaire - 3"
Caregiver report on child's development (younger siblings)
Measured: Through study completion (4 years)
"Mullen Scale of Early Learning"
Observation of child's cognitive, motor, and linguistic development (younger siblings)
Measured: Through study completion (4 years)
"Kaufman Assessment Battery for Children-2"
Observation of child's cognitive and linguistic development (CRT children and older siblings)
Measured: Through study completion (4 years)
"Wechsler Preschool & Primary Scale of Intelligence"
Observation of child's cognitive and linguistic development
Measured: 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)
Measured: Through study completion (4 years)
"Multiple Indicator Cluster Survey" child discipline module
Caregiver self-report of child discipline practices and behaviors (for all children)
Measured: 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)
Measured: Through study completion (4 years)
DHS "Intimate Partner Violence" survey
Caregiver self-report on victimization and perpetration of intimate partner violence
Measured: Through study completion (4 years)
"Child Behavior Checklist"
Caregiver report on child's internalizing and/or externalizing (CRT children and older siblings)
Measured: Through study completion (4 years)
Secondary outcomes (22)
"Observation of Mother-Child Interactions"
Observation of caregiver's sensitive care (younger siblings)
Measured: Through study completion (4 years)
"The Role of Play in Children's Learning"
Caregiver self-report on play for children's learning and development
Measured: Through study completion (4 years)
"Parental Acceptance-Rejection Questionnaire"
Caregiver self-report of stimulating care and play
Measured: Through study completion (4 years)
DHS/Promundo "Father Engagement & Financial Decision-Making" survey
Caregiver self-report of financial decision making and father engagement in the family
Measured: Through study completion (4 years)
"Gender Equitable Men" scale
Caregiver self-report of views of gender and masculinity
Measured: Through study completion (4 years)
"Multiple Indicator Cluster Survey (5)" WASH module
Caregiver self-report of home sanitation \& hygiene
Measured: Through study completion (4 years)
World Health Organization "Infant and Young Child Feeding Practices" survey
Caregiver self-report of feeding practices
Measured: Through study completion (4 years)
"Hopkins Symptom Checklist (25)"
Diagnostic tool for depression and anxiety in caregivers
Measured: Through study completion (4 years)
"Enrollment in early education" survey
Caregiver report of child's enrollment in early education
Measured: Through study completion (4 years)
"Child Enrollment in Formal Education" survey
Caregiver report of child's enrollment in formal education
Measured: Through study completion (4 years)
"Service utilization" survey
Caregiver self-report on services utilized, e.g. government and non-governmental inputs and services
Measured: Through study completion (4 years)
Anthropometric measures: height in centimeters
Measure of child height in centimeters (younger siblings and CRT children)
Measured: Through study completion (4 years)
"Preschool Self-Regulation Assessment"
Caregiver report of child's self-regulation (CRT children)
Measured: Through study completion (4 years)
"Infant Behavior Questionnaire"
Caregiver report of child's temperament (younger siblings)
Measured: Through study completion (4 years)
"Early Childhood Behavior Questionnaire"
Caregiver report of child's temperament (younger siblings)
Measured: Through study completion (4 years)
"Early Grade Reading Assessment"
Assessment of early literacy skills in children (older siblings)
Measured: Through study completion (4 years)
"Center for Epidemiological Studies Depression Scale"
Diagnostic tool for depression in children (older siblings)
Measured: Through study completion (4 years)
"Gender Equitable Men" scale
Child self-report of views of gender and masculinity (older siblings)
Measured: Through study completion (4 years)
Anthropometric measures: weight in kilograms
Measure of child weight in kilograms (younger siblings and CRT children)
Measured: Through study completion (4 years)
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)
Measured: Through study completion (4 years)
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)
Measured: Through study completion (4 years)
Anthropometric measures: middle upper arm circumference in centimeters
Measure of child circumference of middle upper arm in centimeters (younger siblings and CRT children)
Measured: Through study completion (4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start20 Apr 2022
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,932 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Theresa Betancourt, Boston College
- Investigators
- Theresa S Betancourt, ScD, MA, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405400
- Sponsor's protocol ID
- 22.198.01
- Status last verified
- Aug 2025
- First submitted
- 27 May 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32375840Britto 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 27717615Jensen 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 at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Longer-term Effects of a Father-engaged, Play-based Home Visiting Intervention to Promote Early Childhood Development and Prevent Violence in Rwanda: The Sugira Muryango Longitudinal & Spillover Study
- ClinicalTrials.gov ID
- NCT05405400
- Acronym / sponsor ID
- 22.198.01
- Conditions
- Cognitive Change, Growth; Stunting, Nutritional, Language, Depression, Behavior, Violence
- Keywords
- Early childhood development, Intimate partner violence, Rwanda, Intervention, Longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,932 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- University of Rwanda, FXB-Rwanda, LEGO Foundation, The ELMA Foundation, Echidna Giving, Wellspring Philanthropic Fund, United States Agency for International Development (USAID)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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
- Sugira Muryango will have effects on new outcomes that have become relevant as the children have aged, including aspects of school readiness. Spillover Hypothesis
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
"Home Observation Measurement of the Environment" infants/toddlers survey and early childhood survey
Time frame: Through study completion (4 years)
Observation of caregiver engagement and stimulation of children (younger siblings and CRT children)
"Ages & Stages Questionnaire - 3"
Time frame: Through study completion (4 years)
Caregiver report on child's development (younger siblings)
"Mullen Scale of Early Learning"
Time frame: Through study completion (4 years)
Observation of child's cognitive, motor, and linguistic development (younger siblings)
"Kaufman Assessment Battery for Children-2"
Time frame: Through study completion (4 years)
Observation of child's cognitive and linguistic development (CRT children and older siblings)
"Wechsler Preschool & Primary Scale of Intelligence"
Time frame: Through study completion (4 years)
Observation of child's cognitive and linguistic development
"International Development & Early Learning Assessment" stimulating care and play module
Time frame: Through study completion (4 years)
Caregiver report on playful parenting activities and childcare arrangement (for all children)
"Multiple Indicator Cluster Survey" child discipline module
Time frame: Through study completion (4 years)
Caregiver self-report of child discipline practices and behaviors (for all children)
Combined module based on "Multiple Indicator Cluster Survey" and "ISPCAN Child Abuse Screening Tool"
Time frame: Through study completion (4 years)
Child self-report of experiences of discipline and violence (older siblings)
DHS "Intimate Partner Violence" survey
Time frame: Through study completion (4 years)
Caregiver self-report on victimization and perpetration of intimate partner violence
"Child Behavior Checklist"
Time frame: Through study completion (4 years)
Caregiver report on child's internalizing and/or externalizing (CRT children and older siblings)
22 secondary outcomes
"Observation of Mother-Child Interactions"
Time frame: Through study completion (4 years)
"The Role of Play in Children's Learning"
Time frame: Through study completion (4 years)
"Parental Acceptance-Rejection Questionnaire"
Time frame: Through study completion (4 years)
DHS/Promundo "Father Engagement & Financial Decision-Making" survey
Time frame: Through study completion (4 years)
"Gender Equitable Men" scale
Time frame: Through study completion (4 years)
"Multiple Indicator Cluster Survey (5)" WASH module
Time frame: Through study completion (4 years)
World Health Organization "Infant and Young Child Feeding Practices" survey
Time frame: Through study completion (4 years)
"Hopkins Symptom Checklist (25)"
Time frame: Through study completion (4 years)
"Enrollment in early education" survey
Time frame: Through study completion (4 years)
"Child Enrollment in Formal Education" survey
Time frame: Through study completion (4 years)
"Service utilization" survey
Time frame: Through study completion (4 years)
Anthropometric measures: height in centimeters
Time frame: Through study completion (4 years)
"Preschool Self-Regulation Assessment"
Time frame: Through study completion (4 years)
"Infant Behavior Questionnaire"
Time frame: Through study completion (4 years)
"Early Childhood Behavior Questionnaire"
Time frame: Through study completion (4 years)
"Early Grade Reading Assessment"
Time frame: Through study completion (4 years)
"Center for Epidemiological Studies Depression Scale"
Time frame: Through study completion (4 years)
"Gender Equitable Men" scale
Time frame: Through study completion (4 years)
Anthropometric measures: weight in kilograms
Time frame: Through study completion (4 years)
Anthropometric measures: standardized height-for-weight
Time frame: Through study completion (4 years)
Anthropometric measures: standardized height-for-age
Time frame: Through study completion (4 years)
Anthropometric measures: middle upper arm circumference in centimeters
Time frame: Through study completion (4 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- BackgroundBarnhart, 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
- BackgroundBetancourt, 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: PubMed 32375840Betancourt 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.
- Background: PubMed 27717615Britto 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.
- Background: PubMed 33514591Jensen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa S Betancourt, ScD, MA principal investigator
Boston College
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Change and Growth; Stunting, Nutritional, run by Boston College at 3 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Home Observation Measurement of the Environment" infants/toddlers survey and early childhood survey (time frame: Through study completion (4 years)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405400, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.