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
NCT number | NCT05405400 |
Other study ID # | 22.198.01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 20, 2022 |
Est. completion date | December 31, 2022 |
Verified date | February 2023 |
Source | Boston College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2932 |
Est. completion date | December 31, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months and older |
Eligibility | Participated in the Sugira Muryango CRT in 2018-19 (Trial Registration Number NCT02510313). Family inclusion criteria for the CRT were: - living in the Rubavu, Ngoma or Nyanza District of Rwanda - being VUP-eligible (according to the Rwandan government) - having at least one child aged 6-36 months living in the home - having at least one caregiver who was willing to discuss and enhance their caregiving practices by interacting with a home-visiting coach (a community-based volunteer or CBV). Further caregiver inclusion criteria were: - was aged 18 or older and cared for child(ren) - lived in the same household as the child(ren). For the current Longitudinal Study, inclusion criteria for families are - having participated in the prior CRT - living in Ngoma, Nyanza, or Rubavu districts - having at least one child who participated in the CRT and who is currently living in the household. Inclusion criteria for younger siblings are: - aged 3 months or older - was not eligible to participate in the original CRT due to age (below 6 months or not yet born at the time of CRT). Inclusion criteria for older siblings are: - aged 12 years or younger - lived in the household but was not eligible to participate in the original CRT due to age (above 36 months at the time of CRT) - currently lives in the household that participated in the CRT. Exclusion Criteria: Other than not meeting inclusion criteria, specific family exclusion criteria for the CRT were: - caregiver(s) having severe cognitive impairments which precluded their ability to speak to the research questions under study - families or caregivers being in the midst of crisis (e.g., a caregiver(s) with active suicidal attempts or psychosis). Families with ongoing crises or disabilities were excluded from the study and were referred to appropriate services. - These exclusion criteria remain the same for the current Longitudinal study. - Siblings will be excluded from sampling for the spillover study if the primary caregiver has been away from the household for six months or more. |
Country | Name | City | State |
---|---|---|---|
Rwanda | Homes and community buildings | Ngoma | |
Rwanda | Homes and community buildings | Nyanza | |
Rwanda | Homes and community buildings | Rubavu |
Lead Sponsor | Collaborator |
---|---|
Boston College | Echidna Giving, FXB-Rwanda, LEGO Foundation, The ELMA Foundation, United States Agency for International Development (USAID), University of Rwanda, Wellspring Philanthropic Fund |
Rwanda,
Barnhart, D. A., Farrar, J., Murray, S. M., Brennan, R. T., Antonaccio, C., Sezibera, V., Ingabire, C., Godfroid, K., Bazubagira, S., Uwimana, O., Kamurase, A., Yousafzai, A., Betancourt, T. (2020). Lay-worker delivered home promotes early childhood development and reduces violence in Rwanda; a randomized pilot. Journal of Child and Family Studies; 29, 1804-1817. https://doi.org/10.1007/s10826-020-01709-1
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. — View Citation
Betancourt, T. S., Franchett, E., Kirk, C. M., Brennan, R. T., Rawlings, L., Wilson, B., ... & Ukundineza, C. (2018). Integrating social protection and early childhood development: open trial of a family home-visiting intervention, Sugira Muryango. Early Child Development and Care; 190(2), 219-235.
Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | "International Development & Early Learning Assessment" parent attitudes module | Caregiver self-report of attitudes towards children's education | Through study completion (4 years) | |
Other | "International Development & Early Learning Assessment" parent expectations module | Caregiver self-report of expectations towards children's education | Through study completion (4 years) | |
Other | Epstein survey | Caregiver self-report of support for children's education | Through study completion (4 years) | |
Other | World Health Organization "Alcohol Use Disorders Identification Test (AUDIT)" | Caregiver self-report of alcohol use and/or abuse | Through study completion (4 years) | |
Other | "Flourishing Scale" | Caregiver self-report on quality of life | Through study completion (4 years) | |
Other | "Gender Equitable Men" norms scale | Caregiver self-report of perceived norms related to gender and masculinity | Through study completion (4 years) | |
Other | "Youth Conduct Problems Scale - Rwanda" | Child self-report of conduct problems (older siblings) | Through study completion (4 years) | |
Primary | "Home Observation Measurement of the Environment" infants/toddlers survey and early childhood survey | Observation of caregiver engagement and stimulation of children (younger siblings and CRT children) | Through study completion (4 years) | |
Primary | "Ages & Stages Questionnaire - 3" | Caregiver report on child's development (younger siblings) | Through study completion (4 years) | |
Primary | "Mullen Scale of Early Learning" | Observation of child's cognitive, motor, and linguistic development (younger siblings) | Through study completion (4 years) | |
Primary | "Kaufman Assessment Battery for Children-2" | Observation of child's cognitive and linguistic development (CRT children and older siblings) | Through study completion (4 years) | |
Primary | "Wechsler Preschool & Primary Scale of Intelligence" | Observation of child's cognitive and linguistic development | Through study completion (4 years) | |
Primary | "International Development & Early Learning Assessment" stimulating care and play module | Caregiver report on playful parenting activities and childcare arrangement (for all children) | Through study completion (4 years) | |
Primary | "Multiple Indicator Cluster Survey" child discipline module | Caregiver self-report of child discipline practices and behaviors (for all children) | Through study completion (4 years) | |
Primary | Combined module based on "Multiple Indicator Cluster Survey" and "ISPCAN Child Abuse Screening Tool" | Child self-report of experiences of discipline and violence (older siblings) | Through study completion (4 years) | |
Primary | DHS "Intimate Partner Violence" survey | Caregiver self-report on victimization and perpetration of intimate partner violence | Through study completion (4 years) | |
Primary | "Child Behavior Checklist" | Caregiver report on child's internalizing and/or externalizing (CRT children and older siblings) | Through study completion (4 years) | |
Secondary | "Observation of Mother-Child Interactions" | Observation of caregiver's sensitive care (younger siblings) | Through study completion (4 years) | |
Secondary | "The Role of Play in Children's Learning" | Caregiver self-report on play for children's learning and development | Through study completion (4 years) | |
Secondary | "Parental Acceptance-Rejection Questionnaire" | Caregiver self-report of stimulating care and play | Through study completion (4 years) | |
Secondary | DHS/Promundo "Father Engagement & Financial Decision-Making" survey | Caregiver self-report of financial decision making and father engagement in the family | Through study completion (4 years) | |
Secondary | "Gender Equitable Men" scale | Caregiver self-report of views of gender and masculinity | Through study completion (4 years) | |
Secondary | "Multiple Indicator Cluster Survey (5)" WASH module | Caregiver self-report of home sanitation & hygiene | Through study completion (4 years) | |
Secondary | World Health Organization "Infant and Young Child Feeding Practices" survey | Caregiver self-report of feeding practices | Through study completion (4 years) | |
Secondary | "Hopkins Symptom Checklist (25)" | Diagnostic tool for depression and anxiety in caregivers | Through study completion (4 years) | |
Secondary | "Enrollment in early education" survey | Caregiver report of child's enrollment in early education | Through study completion (4 years) | |
Secondary | "Child Enrollment in Formal Education" survey | Caregiver report of child's enrollment in formal education | Through study completion (4 years) | |
Secondary | "Service utilization" survey | Caregiver self-report on services utilized, e.g. government and non-governmental inputs and services | Through study completion (4 years) | |
Secondary | Anthropometric measures: height in centimeters | Measure of child height in centimeters (younger siblings and CRT children) | Through study completion (4 years) | |
Secondary | "Preschool Self-Regulation Assessment" | Caregiver report of child's self-regulation (CRT children) | Through study completion (4 years) | |
Secondary | "Infant Behavior Questionnaire" | Caregiver report of child's temperament (younger siblings) | Through study completion (4 years) | |
Secondary | "Early Childhood Behavior Questionnaire" | Caregiver report of child's temperament (younger siblings) | Through study completion (4 years) | |
Secondary | "Early Grade Reading Assessment" | Assessment of early literacy skills in children (older siblings) | Through study completion (4 years) | |
Secondary | "Center for Epidemiological Studies Depression Scale" | Diagnostic tool for depression in children (older siblings) | Through study completion (4 years) | |
Secondary | "Gender Equitable Men" scale | Child self-report of views of gender and masculinity (older siblings) | Through study completion (4 years) | |
Secondary | Anthropometric measures: weight in kilograms | Measure of child weight in kilograms (younger siblings and CRT children) | Through study completion (4 years) | |
Secondary | Anthropometric measures: standardized height-for-weight | Height and weight will be combined and the resulting scores standardized and reported as z-scores (younger siblings and CRT children) | Through study completion (4 years) | |
Secondary | Anthropometric measures: standardized height-for-age | Height and age will be combined and the resulting scores standardized and reported as z-scores (younger siblings and CRT children) | Through study completion (4 years) | |
Secondary | Anthropometric measures: middle upper arm circumference in centimeters | Measure of child circumference of middle upper arm in centimeters (younger siblings and CRT children) | Through study completion (4 years) |
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