The Sugira Muryango Longitudinal & Spillover Study

Depression Clinical Trial

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

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05405400
• Study type: Observational
• Source: Boston College
• Status: Completed
• Start date: April 20, 2022
• Completion date: December 31, 2022