Child Development, Social ProtectionNCT02510313
Strong Families, Thriving Children "Sugira Muryango"_Activity C
A study testing Sugira Muryango in people with Child Development, Social Protection, run by Boston College at 1 site in Rwanda.
Trial summary
The proposed study will test the effectiveness of the Strong Families, Thriving Children "Sugira Muryango" program as delivered by community based workers and aligned with the Rwandan social protection system. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Child Development, Social Protection
- What is being tested?
- Sugira Muryango
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,911 participants
- Where
- 1 siteRwanda
- Study dates
- 10 Apr 2018to 1 Nov 2019
- Phase
- Interventional
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being VUP-eligible
- having at least one children aged 0-6 years living in the home
- having caregiver willing to discuss and enhance their parenting practices by interacting with a home-visiting coach.
- Caregiver eligibility:
- is aged 18 or older and cares for child(ren)
- lives in the same household as child(ren). We will enroll both single and dual caregiver families to reflect population dynamics. Legal guardians may be aunts, uncles, grandparents, or foster parents.
Who cannot join
- do not live in chosen District of Rwanda
- do not have children between the ages of 0 and 6 years living in their household for whom they are the primary caregiver
- they are not enrolled in Rwanda's public works social protection program VUP, or have severe cognitive impairments which preclude their ability to speak to the research questions under study
- families in the midst of crisis (e.g., a caregiver with active suicidal attempts or psychosis) and refer them to appropriate services.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Trial of a Family Home Visiting Intervention to Promote Early Child Development Among Families Served by the Social Protection System in Rwanda
The proposed study will test the effectiveness of the Strong Families, Thriving Children "Sugira Muryango" program as delivered by community based workers and aligned with the Rwandan social protection system. Sugira Muryango is a preventive, family-based model that uses home visiting and coaching to encourage responsive parent-child interactions and discourage violence and harsh punishment targeting families living in extreme poverty. Integration of scalable, cost-effective interventions into poverty-reduction and other social welfare programs has great potential as an effective means to promote child development and reduce familial violence and in a range of culturally diverse, low-resource settings.
Read the detailed description
Globally, more than 200 million children may not reach their full developmental potential due to poverty and adversity. This is most evident in World Bank-classified Low- and Middle-Income Countries (LMICs) struggling with the confluence of war, community violence, poverty and disease. Research across a range of cultures and settings finds that children living in compounded adversity face increased risks of poor child development outcomes and emotional and behavioral problems that can perpetuate a cycle of poverty and violence. Integrated programs and family-based interventions for promoting child development, healthy parent-child relationships and reducing household violence affecting children are insufficiently tested in culturally diverse and low-resource settings despite compelling data about such risks. The proposed study will investigate the effectiveness of the Sugira Muryango program as an innovative approach to early childhood development promotion. Sugira Muryango is a preventive, family-based model that uses home visiting and caregiver coaching; it encourages responsive caregiver-child interactions and discourages violence and harsh punishment among families living in extreme poverty. By providing home-based coaching that helps parents manage stress, reduce harsh punishment and engage in responsive parenting with early childhood stimulation, it is possible to effect improvements in parent-child relationships and child development outcomes. Sugira Muryango will be implemented alongside Rwanda's flagship poverty reduction initiative, Vision 2020 Umurenge Program (VUP). Classic VUP components mainly focus on cash-for-work on labor intensive public works projects. With government and development partner support, VUP is piloting a more enhanced public works model that has child and gender sensitive components, with flexible public works options that are closer to beneficiary households. Along such the expanded public works program currently under pilot by VUP, a minimum graduation package is also available, which is providing additional variables of financial literacy, asset transfers, skills training, and sensitizations surrounding a range of topics (e.g., education, health, nutrition).
A four-arm cluster randomized trial (CRT) will enroll 1,040 VUP-eligible families with children aged 6-36 months to compare outcomes among children and parents in families receiving: (1) Control/Classic VUP, (2) Expanded VUP, (3) Combined Classic VUP plus Sugira Muryango and (4) Combined Expanded VUP plus Sugira Muryango. A cost analysis will provide practical information on the feasibility and cost of integrating Sugira Muryango into VUP programming and a process evaluation will produce useful implementation tools for dissemination and scale-up.
Study Aims are to (1) assess effectiveness of Sugira Muryango in promoting responsive parenting, reducing violence and harsh punishment and promoting early child development in families living in poverty; (2) to assess the interaction between Sugira Muryano and classic/expanded VUP programming and (3) to assess costs, barriers and facilitators of integrating the Sugira Muryango package into VUP or other government programming, such as the Ministry of Gender and Family Promotion (MIGEPROF), which holds the early childhood development mandate. This initiative seeks to promote cross sectoral and ministerial collaboration, a key pillar of the Government of Rwanda.
- Conditions
- Child Development, Social Protection
- Being tested
- Sugira Muryango
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugira MuryangoOther
Strong Families, Thriving Children "Sugira Muryango" is a home-visiting intervention that empowers low-income families enrolled in Rwanda's social protection system to support early childhood development and healthy family functioning.
| Study group | Role | What they receive |
|---|---|---|
| Classic VUP (Control) | No intervention | Families receive benefits (cash) in exchange for state-sanctioned labour intensive work. |
| Expanded VUP | No intervention | Families receive benefits (cash) in exchange for state-sanctioned flexible labour within close proximity (2 km) to household. Eligible for variation of minimum graduation package benefits, such as asset transfer, financial literacy, skills training, sensitizations. |
| Sugira Muryango & Classic VUP | Experimental | Families receive combination of Sugira Muryango and benefits (cash) in exchange for state-sanctioned labour intensive work. Receives: Other: Sugira Muryango |
| Sugira Muryango & Expanded VUP | Experimental | Families receive combination of Sugira Muryango and benefits (cash) in exchange for state-sanctioned flexible labour within close proximity (2 km) to household. Eligible for variation of minimum graduation package benefits, such as asset transfer, financial literacy, skills training, sensitizations. Receives: Other: Sugira Muryango |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in parent-child relationship
Questionnaires and observations will be used to assess this outcome
Measured: Years 2 & 3
Change from baseline in responsive caregiving practices
Questionnaires and observations will be used to assess this outcome
Measured: Years 2 & 3
Change from baseline in child development
Questionnaires and observations will be used to assess this outcome
Measured: Years 2 & 3
Change from baseline in violence in the home
Questionnaires will be used to assess this outcome
Measured: Years 2 & 3
Change from baseline in child health and nutrition
Questionnaires and observations will be used to assess this outcome
Measured: Years 2 & 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start10 Apr 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Child Development, Social ProtectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study design consists of a four-arm cluster randomized control trial (CRT), which will span approximately 52 cells in 3 districts of Rwanda to compare outcomes among VUP eligible households with at least one child 6-36 months in the following study arms: * Classic VUP public works (control) * Expanded VUP public works (control) * Combined Classic VUP public works with Sugira Muryango (treatment) * Combined Expanded VUP public works with Sugira Muryango (treatment)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Betancourt, Boston College
- Investigators
- Theresa Betancourt, Sc.D, Principal investigator, Boston College School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510313
- Sponsor's protocol ID
- IRB16-1570
- Status last verified
- Feb 2020
- First submitted
- 26 Jul 2015
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shonkoff JP. Building a new biodevelopmental framework to guide the future of early childhood policy. Child Dev. 2010 Jan-Feb;81(1):357-67. doi: 10.1111/j.1467-8624.2009.01399.x.
PubMed 20331672Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Dyregrov A, Gupta L, Gjestad R, Mukanoheli E. Trauma exposure and psychological reactions to genocide among Rwandan children. J Trauma Stress. 2000 Jan;13(1):3-21. doi: 10.1023/A:1007759112499.
PubMed 10761171Betancourt TS, Ng LC, Kirk CM, Munyanah M, Mushashi C, Ingabire C, Teta S, Beardslee WR, Brennan RT, Zahn I, Stulac S, Cyamatare FR, Sezibera V. Family-based prevention of mental health problems in children affected by HIV and AIDS: an open trial. AIDS. 2014 Jul;28 Suppl 3(0 3):S359-68. doi: 10.1097/QAD.0000000000000336.
PubMed 24991909Jensen SGK, Placencio-Castro M, Murray SM, Littman J, Bazubagira SM, Uwizeye D, Sezibera V, Betancourt TS. Four-year follow-up to a home-visiting intervention to promote early childhood development and prevent family violence in rural Rwanda: the Sugira Muryango cluster randomised trial. BMJ Glob Health. 2025 Jun 8;10(6):e017866. doi: 10.1136/bmjgh-2024-017866.
PubMed 40484411Jensen 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 33514591Betancourt 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Trial of a Family Home Visiting Intervention to Promote Early Child Development Among Families Served by the Social Protection System in Rwanda
- ClinicalTrials.gov ID
- NCT02510313
- Acronym / sponsor ID
- IRB16-1570
- Conditions
- Child Development, Social Protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,911 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 29 Jul 2015 (estimated)
- 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 proposed study will test the effectiveness of the Strong Families, Thriving Children "Sugira Muryango" program as delivered by community based workers and aligned with the Rwandan social protection system. Sugira Muryango is a preventive, family-based model that uses home visiting and coaching to encourage responsive parent-child interactions and discourage violence and harsh punishment targeting families living in extreme poverty. Integration of scalable, cost-effective interventions into poverty-reduction and other social welfare programs has great potential as an effective means to promote child development and reduce familial violence and in a range of culturally diverse, low-resource settings.
Detailed description
Globally, more than 200 million children may not reach their full developmental potential due to poverty and adversity. This is most evident in World Bank-classified Low- and Middle-Income Countries (LMICs) struggling with the confluence of war, community violence, poverty and disease. Research across a range of cultures and settings finds that children living in compounded adversity face increased risks of poor child development outcomes and emotional and behavioral problems that can perpetuate a cycle of poverty and violence. Integrated programs and family-based interventions for promoting child development, healthy parent-child relationships and reducing household violence affecting children are insufficiently tested in culturally diverse and low-resource settings despite compelling data about such risks. The proposed study will investigate the effectiveness of the Sugira Muryango program as an innovative approach to early childhood development promotion. Sugira Muryango is a preventive, family-based model that uses home visiting and caregiver coaching; it encourages responsive caregiver-child interactions and discourages violence and harsh punishment among families living in extreme poverty. By providing home-based coaching that helps parents manage stress, reduce harsh punishment and engage in responsive parenting with early childhood stimulation, it is possible to effect improvements in parent-child relationships and child development outcomes. Sugira Muryango will be implemented alongside Rwanda's flagship poverty reduction initiative, Vision 2020 Umurenge Program (VUP). Classic VUP components mainly focus on cash-for-work on labor intensive public works projects. With government and development partner support, VUP is piloting a more enhanced public works model that has child and gender sensitive components, with flexible public works options that are closer to beneficiary households. Along such the expanded public works program currently under pilot by VUP, a minimum graduation package is also available, which is providing additional variables of financial literacy, asset transfers, skills training, and sensitizations surrounding a range of topics (e.g., education, health, nutrition).
A four-arm cluster randomized trial (CRT) will enroll 1,040 VUP-eligible families with children aged 6-36 months to compare outcomes among children and parents in families receiving: (1) Control/Classic VUP, (2) Expanded VUP, (3) Combined Classic VUP plus Sugira Muryango and (4) Combined Expanded VUP plus Sugira Muryango. A cost analysis will provide practical information on the feasibility and cost of integrating Sugira Muryango into VUP programming and a process evaluation will produce useful implementation tools for dissemination and scale-up.
Study Aims are to (1) assess effectiveness of Sugira Muryango in promoting responsive parenting, reducing violence and harsh punishment and promoting early child development in families living in poverty; (2) to assess the interaction between Sugira Muryano and classic/expanded VUP programming and (3) to assess costs, barriers and facilitators of integrating the Sugira Muryango package into VUP or other government programming, such as the Ministry of Gender and Family Promotion (MIGEPROF), which holds the early childhood development mandate. This initiative seeks to promote cross sectoral and ministerial collaboration, a key pillar of the Government of Rwanda.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The proposed study design consists of a four-arm cluster randomized control trial (CRT), which will span approximately 52 cells in 3 districts of Rwanda to compare outcomes among VUP eligible households with at least one child 6-36 months in the following study arms: * Classic VUP public works (control) * Expanded VUP public works (control) * Combined Classic VUP public works with Sugira Muryango (treatment) * Combined Expanded VUP public works with Sugira Muryango (treatment)
| Arm | Type | Receives |
|---|---|---|
| Classic VUP (Control) | No intervention | –Families receive benefits (cash) in exchange for state-sanctioned labour intensive work. |
| Expanded VUP | No intervention | –Families receive benefits (cash) in exchange for state-sanctioned flexible labour within close proximity (2 km) to household. Eligible for variation of minimum graduation package benefits, such as asset transfer, financial literacy, skills training, sensitizations. |
| Sugira Muryango & Classic VUP | Experimental | Other: Sugira MuryangoFamilies receive combination of Sugira Muryango and benefits (cash) in exchange for state-sanctioned labour intensive work. |
| Sugira Muryango & Expanded VUP | Experimental | Other: Sugira MuryangoFamilies receive combination of Sugira Muryango and benefits (cash) in exchange for state-sanctioned flexible labour within close proximity (2 km) to household. Eligible for variation of minimum graduation package benefits, such as asset transfer, financial literacy, skills training, sensitizations. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- being VUP-eligible
- having at least one children aged 0-6 years living in the home
- having caregiver willing to discuss and enhance their parenting practices by interacting with a home-visiting coach.
- is aged 18 or older and cares for child(ren)
- lives in the same household as child(ren). We will enroll both single and dual caregiver families to reflect population dynamics. Legal guardians may be aunts, uncles, grandparents, or foster parents.
Key exclusion criteria (4 listed)
- do not live in chosen District of Rwanda
- do not have children between the ages of 0 and 6 years living in their household for whom they are the primary caregiver
- they are not enrolled in Rwanda's public works social protection program VUP, or have severe cognitive impairments which preclude their ability to speak to the research questions under study
- families in the midst of crisis (e.g., a caregiver with active suicidal attempts or psychosis) and refer them to appropriate services.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugira MuryangoStrong Families, Thriving Children "Sugira Muryango" is a home-visiting intervention that empowers low-income families enrolled in Rwanda's social protection system to support early childhood development and healthy family functioning. | Other | Sugira Muryango & Classic VUP, Sugira Muryango & Expanded VUP |
Primary outcome
Change from baseline in parent-child relationship
Time frame: Years 2 & 3
Questionnaires and observations will be used to assess this outcome
Change from baseline in responsive caregiving practices
Time frame: Years 2 & 3
Questionnaires and observations will be used to assess this outcome
Change from baseline in child development
Time frame: Years 2 & 3
Questionnaires and observations will be used to assess this outcome
Change from baseline in violence in the home
Time frame: Years 2 & 3
Questionnaires will be used to assess this outcome
Change from baseline in child health and nutrition
Time frame: Years 2 & 3
Questionnaires and observations will be used to assess this outcome
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 12 Feb 2020.
- Background: PubMed 20331672Shonkoff JP. Building a new biodevelopmental framework to guide the future of early childhood policy. Child Dev. 2010 Jan-Feb;81(1):357-67. doi: 10.1111/j.1467-8624.2009.01399.x.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 10761171Dyregrov A, Gupta L, Gjestad R, Mukanoheli E. Trauma exposure and psychological reactions to genocide among Rwandan children. J Trauma Stress. 2000 Jan;13(1):3-21. doi: 10.1023/A:1007759112499.
- Background: PubMed 24991909Betancourt TS, Ng LC, Kirk CM, Munyanah M, Mushashi C, Ingabire C, Teta S, Beardslee WR, Brennan RT, Zahn I, Stulac S, Cyamatare FR, Sezibera V. Family-based prevention of mental health problems in children affected by HIV and AIDS: an open trial. AIDS. 2014 Jul;28 Suppl 3(0 3):S359-68. doi: 10.1097/QAD.0000000000000336.
- Derived from this study: PubMed 40484411Jensen SGK, Placencio-Castro M, Murray SM, Littman J, Bazubagira SM, Uwizeye D, Sezibera V, Betancourt TS. Four-year follow-up to a home-visiting intervention to promote early childhood development and prevent family violence in rural Rwanda: the Sugira Muryango cluster randomised trial. BMJ Glob Health. 2025 Jun 8;10(6):e017866. doi: 10.1136/bmjgh-2024-017866.
- Derived from this study: 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.
- Derived from this study: 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.
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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 Betancourt, Sc.D principal investigator
Boston College School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugira Muryango in people with Child Development, Social Protection, run by Boston College at 1 site 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 6 inclusion and 4 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline in parent-child relationship (time frame: Years 2 & 3). The study lists 5 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 NCT02510313, which also lists 7 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 12 Feb 2020.