The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
NCT03226912
Anxiety, Anxiety Disorders
Melbourne, Victoria, Australia
View Trial DetailsNCT Number: NCT05405400
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.
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Notify Me3 month and older
All sexes
Observational
Homes and community buildings, Ngoma, Rwanda
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:
Our specific hypotheses are as follows:
Longitudinal Hypotheses
Spillover Hypothesis
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Participated in the Sugira Muryango CRT in 2018-19 (Trial Registration Number NCT02510313).
Family inclusion criteria for the CRT were:
Further caregiver inclusion criteria were:
Inclusion criteria
for younger siblings are:
Inclusion criteria
for older siblings are:
Exclusion criteria
Other than not meeting inclusion criteria, specific family exclusion criteria for the CRT were:
Time frame: Through study completion (4 years)
Observation of caregiver engagement and stimulation of children (younger siblings and CRT children)
Time frame: Through study completion (4 years)
Caregiver report on child's development (younger siblings)
Time frame: Through study completion (4 years)
Observation of child's cognitive, motor, and linguistic development (younger siblings)
Time frame: Through study completion (4 years)
Observation of child's cognitive and linguistic development (CRT children and older siblings)
Time frame: Through study completion (4 years)
Observation of child's cognitive and linguistic development
Time frame: Through study completion (4 years)
Caregiver report on playful parenting activities and childcare arrangement (for all children)
Time frame: Through study completion (4 years)
Caregiver self-report of child discipline practices and behaviors (for all children)
Time frame: Through study completion (4 years)
Child self-report of experiences of discipline and violence (older siblings)
Time frame: Through study completion (4 years)
Caregiver self-report on victimization and perpetration of intimate partner violence
Time frame: Through study completion (4 years)
Caregiver report on child's internalizing and/or externalizing (CRT children and older siblings)
Time frame: Through study completion (4 years)
Observation of caregiver's sensitive care (younger siblings)
Time frame: Through study completion (4 years)
Caregiver self-report on play for children's learning and development
Time frame: Through study completion (4 years)
Caregiver self-report of stimulating care and play
Time frame: Through study completion (4 years)
Caregiver self-report of financial decision making and father engagement in the family
Time frame: Through study completion (4 years)
Caregiver self-report of views of gender and masculinity
Time frame: Through study completion (4 years)
Caregiver self-report of home sanitation & hygiene
Time frame: Through study completion (4 years)
Caregiver self-report of feeding practices
Time frame: Through study completion (4 years)
Diagnostic tool for depression and anxiety in caregivers
Time frame: Through study completion (4 years)
Caregiver report of child's enrollment in early education
Time frame: Through study completion (4 years)
Caregiver report of child's enrollment in formal education
Time frame: Through study completion (4 years)
Caregiver self-report on services utilized, e.g. government and non-governmental inputs and services
Time frame: Through study completion (4 years)
Measure of child height in centimeters (younger siblings and CRT children)
Time frame: Through study completion (4 years)
Caregiver report of child's self-regulation (CRT children)
Time frame: Through study completion (4 years)
Caregiver report of child's temperament (younger siblings)
Time frame: Through study completion (4 years)
Caregiver report of child's temperament (younger siblings)
Time frame: Through study completion (4 years)
Assessment of early literacy skills in children (older siblings)
Time frame: Through study completion (4 years)
Diagnostic tool for depression in children (older siblings)
Time frame: Through study completion (4 years)
Child self-report of views of gender and masculinity (older siblings)
Time frame: Through study completion (4 years)
Measure of child weight in kilograms (younger siblings and CRT children)
Time frame: Through study completion (4 years)
Height and weight will be combined and the resulting scores standardized and reported as z-scores (younger siblings and CRT children)
Time frame: Through study completion (4 years)
Height and age will be combined and the resulting scores standardized and reported as z-scores (younger siblings and CRT children)
Time frame: Through study completion (4 years)
Measure of child circumference of middle upper arm in centimeters (younger siblings and CRT children)
Time frame: Through study completion (4 years)
Caregiver self-report of attitudes towards children's education
Time frame: Through study completion (4 years)
Caregiver self-report of expectations towards children's education
Time frame: Through study completion (4 years)
Caregiver self-report of support for children's education
Time frame: Through study completion (4 years)
Caregiver self-report of alcohol use and/or abuse
Time frame: Through study completion (4 years)
Caregiver self-report on quality of life
Time frame: Through study completion (4 years)
Caregiver self-report of perceived norms related to gender and masculinity
Time frame: Through study completion (4 years)
Child self-report of conduct problems (older siblings)
Boston College
Other
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
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