NCT02510313

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,911

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
2.7 years until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

July 26, 2015

Last Update Submit

February 10, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in parent-child relationship

    Questionnaires and observations will be used to assess this outcome

    Years 2 & 3

  • Change from baseline in responsive caregiving practices

    Questionnaires and observations will be used to assess this outcome

    Years 2 & 3

  • Change from baseline in child development

    Questionnaires and observations will be used to assess this outcome

    Years 2 & 3

  • Change from baseline in violence in the home

    Questionnaires will be used to assess this outcome

    Years 2 & 3

  • Change from baseline in child health and nutrition

    Questionnaires and observations will be used to assess this outcome

    Years 2 & 3

Study Arms (4)

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.

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.

Other: Sugira Muryango

Interventions

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.

Sugira Muryango & Classic VUPSugira Muryango & Expanded VUP

Eligibility Criteria

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

You may qualify if:

  • \- All participants must live in chosen District(s) of Rwanda.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FXB Rwanda

Kigali, Rwanda

Location

Related Publications (7)

  • 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.

    PMID: 20331672BACKGROUND
  • Curran 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.

    PMID: 22310560BACKGROUND
  • Dyregrov 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.

    PMID: 10761171BACKGROUND
  • Betancourt 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.

    PMID: 24991909BACKGROUND
  • Jensen 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.

  • 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.

  • 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.

Study Officials

  • Theresa Betancourt, Sc.D

    Boston College School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Our study works with Laterite to oversee data collection in the field. Laterite enumerators are blind to study condition and therefore do not know which study arm, apart from their VUP status (class or expanded), participants have been randomized into.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Salem Professor in Global Practice

Study Record Dates

First Submitted

July 26, 2015

First Posted

July 29, 2015

Study Start

April 10, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations