The Sugira Muryango PLAY Collaborative

NCT04257383 | Completed

• 1 other identifier: 001210997
• Study Type: interventional
• Target: 1,333
• Locations: 1 country
• Sites: 1

Brief Summary

The Research Program on Children and Adversity (RPCA) has successfully grown its evidence-based home-visiting program-Sugira Muryango (SM)-in Rwanda, as policies and programs aligned with the Rwandan social protection system have evolved. The current study submission seeks to test an evidence-based implementation strategy, the PLAY Collaborative, to engage local stakeholders and frontline providers and supervisors to ensure quality improvement and sustainability of Sugira Muryango and to repeat our previous intervention to include Ubudehe 1 families with children 0-36 months in Nyanza, Ngoma, and Rubavu Districts in Rwanda.

Conditions

Child Development; Parenting; Parent-Child Relations; Child Malnutrition

Outcome Measures

Primary Outcomes (9)

• Home Observation for Measurement of the Environment (HOME) Inventory

  The HOME is a 43-item survey to assess responsive caregiving. The HOME combines observation of parenting behaviors and household conditions with caregiver report. Items are summed to derive a total score with a minimum score of 0 and a maximum score of 43. Higher home scores indicate higher levels of responsive caregiving. Baseline will provide a baseline assessment of responsive caregiving while follow-up assessments will assess change over time.

  baseline, 4-months, 16-months

• Observation of Mother-Child Interaction (OMCI)

  The OMCI assesses responsive caregiving via a five-minute interaction that is scored according to published guidelines. The maximum OMCI score is 57 (minimum= 0) with higher scores indicating higher levels of responsive caregiving. Baseline will provide a baseline assessment of responsive caregiving while follow-up assessments will assess change over time.

  baseline, 4-months, 16-months

• UNICEF MICS Family Care Indicators (FCI)

  The UNICEF MICS Family Care Indicators is a cumulative score of caregivers' self-reported engagement in stimulating activities with the child during the prior three days. The maximum score is 6 (minimum score=0) with higher scores indicating higher levels of caregiver engagement in stimulating activities. Baseline will provide a baseline assessment of caregiver engagement while follow-up assessments will assess change over time.

  baseline, 4-months, 16-months

• Dissemination and Implementation Measure (D&I)

  This measure is administered to interventionists, households, and organizations. It assess key implementation science domains related to buy-in, acceptability, feasibility, and appropriateness. Items are scored on a 4-point Likert scale (0-3) with higher scores indicating higher buy-in, acceptability, feasibility, etc. Baseline will provide a baseline assessment of these constructs while follow-up assessments will assess change over time.

  baseline and 4-months

• Program Sustainability Assessment Tool (PSAT)

  This assessment is administered to providers and organizations. It assesses sustainability of the Sugira Muryango intervention across 8 domains (environment, funding stability, partnerships, organizational capacity, program evaluation, program adaption, communication, strategic planning). The PSAT includes 40 items that are scored on a 7-point Likert scale (1-7) with higher scores indicating higher capacity for program sustainability. Baseline will provide a baseline assessment of program sustainability while follow-up assessments will assess change over time.

  baseline and 4-months

• Malawi Development Assessment Tool (MDAT)

  The MDAT is an observational, task-based measure used to asses child development across domain of gross motor, fine motor, language and socio-emotional development. Standardization of score is done relative to data from the SHINE study from Malawi provided by the MDAT team. Baseline will provide a baseline assessment of child development while follow-up assessments will assess change over time.

  baseline, 4-months, 16-months

• Ages and Stages Questionnaire-3 (ASQ-3)

  The ASQ uses a series of parent-completed range age-specific questionnaires designed to screen for developmental delay of children in the areas of gross motor skills, fine motor skills, communication, and problem solving. The ASQ-3 is scored using standard guidelines for standardization resulting in binary outcome variables for each domain indicating whether or not the child showed "developmental delay" vs. "no developmental delay. Baseline will provide a baseline assessment of child development while follow-up assessments will assess change over time.

  baseline, 4-months, 16-months

• UNICEF MICS: Child Discipline Module

  Assesses children's exposure to violent and nonviolent discipline. Exposure to violence is assessed by summing the exposures and creating a continuous score that can range from 0 to 13. Baseline will provide a baseline assessment of child discipline while follow-up assessments will assess change over time.

  baseline, 4-months, 16-months

• Rwanda Demographic Health Survey- Intimate Partner Violence

  Indicators from the Rwanda DHS cover topics related to perpetration and victimization of violence between intimate partners.

  baseline, 4-months, 16-months

Secondary Outcomes (3)

• Rwanda Demographic and Health Survey (DHS)

  baseline, 4-months, 16-months

• WHO infant and young child feeding practices

  baseline, 4-months, 16-months

• Child Anthropometrics

  baseline, 4-months, 16-months

Other Outcomes (4)

• Hopkin's Symptom Checklist (HSCL)

  baseline, 4-months, 16-months

• Difficulties in Emotion Regulation (DERS)

  baseline, 4-months, 16-months

• WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

  baseline, 4-months, 16-months

Study Arms (2)

Treatment

EXPERIMENTAL

Families in the treatment cells will receive the Sugira Muryango treatment immediately after household identification and enrollment.

Other: Sugira Muryango

Waitlist Control

EXPERIMENTAL

Families in the control cells will receive the Sugira Muryango treatment following the completion of the 12-month follow up on the original treatment group.

Other: Sugira Muryango

Interventions

Sugira Muryango OTHER

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.

Treatment; Waitlist Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Boston College: lead
• FXB: collaborator
• Laterite: collaborator
• LEGO: collaborator
• Grand Challenges Canada: collaborator
• Echidna Giving: collaborator
• The ELMA Foundation: collaborator
• InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company: collaborator

Study Sites (1)

FXB Rwanda

Kigali, Rwanda

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

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 participants have been clustered and randomized into.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Salem Professor in Global Practice

Model Details: The proposed study design consists of a two-arm cluster randomized control trial (CRT), which will span approximately 36 cells in 3 districts of Rwanda to compare outcomes among VUP eligible households with at least one child birth-36 months old in the following study arms: treatment and waitlist control. For the embedded quasi experimental study, we aim to enroll 540 households. These households will be assessed at baseline (pre-intervention), midline (post-intervention) and endline (12-months follow-up).

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 6, 2020
• Study Start: May 5, 2021
• Primary Completion: November 4, 2022
• Study Completion: December 31, 2023
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

RW (1)