Trials / Recruiting

RecruitingNCT06941831

Rwanda Digital Dashboard Hybrid Type 3 Implementation Study

Testing an mHealth Digital Dashboard to Improve Quality of Delivery of Evidence-based Interventions That Promote Family Mental Health and Functioning in Rwanda: A Hybrid Type 3 Study

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 1,810 (estimated)

Sponsor: Boston College · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

Mental disorders are leading causes of the health-related burden globally, and in Rwanda the intergenerational mental health consequences of the 1994 Genocide against the Tutsi persist and are further compounded by poverty, such that recent studies have found 20% of the Rwandan population has one or more mental disorders. The Research Program on Children and Adversity (RPCA) has expanded its evidence-based home-visiting Sugira Muryango (SM) in Rwanda. The current study aims to assess a digitally enhanced delivery of Sugira Muryango to meet the needs of the Government of Rwanda in expanding the mental health and social services infrastructure. The proposed research will test the feasibility, acceptability and impact of a technology-enabled service delivery model using a digital tool that streamlines data collection, improves visibility of key program performance metrics, and serves as a resource for learning materials that can be used for continuous learning and training of a non-specialized workforce that is delivering an evidence-based intervention that improves caregiver mental health and family functioning. What the team learn from technology-supported delivery of Sugira Muryango - an evidence-based, trauma-informed, family-based behavioral intervention in Rwanda - can be used to improve the efficiency, effectiveness, and scalability of evidence-based mental health services in Rwanda and globally.

Detailed description

Globally, mental disorders are the second largest contributor to the burden of disease in adults. In settings disrupted by war and civil unrest, violence and loss contribute to significant unaddressed burden of mental disorders and family violence in adults with subsequent risks to children. In Rwanda the intergenerational mental health consequences of the 1994 Genocide against the Tutsi in Rwanda persist; recent studies found that 20% of the Rwandan population has one or more mental disorders with the highest rates observed in Genocide survivors. Sugira Muryango is an evidence-based, trauma-informed, family-based behavioral intervention to promote healthy family functioning, early childhood development and reduce family violence. In several trials, Sugira Muryango has led to improvements in parental mental health and child development outcomes including social and emotional development of children, improved caregiver mental health and reductions in family violence. To support scaling the intervention the University of Rwanda and other partners developed a Digital Dashboard tool that: (a) streamlines collection of data on evidence-based intervention quality and reach; (b) improves visibility and searchability of implementation data by region; (c) facilitates caregiver mental health and social services referrals and follow up; and (d) serves as a training platform with resources to enhance interventionist fidelity and competence. In the context of understanding important factors for scaling evidence-based interventions, the proposed research will investigate dashboard-supported delivery of Sugira Muryango in terms of its reach, efficiency, and cost effectiveness. This Hybrid Type 3 implementation-effectiveness study will collect outcomes measuring the program's effectiveness, quality of program delivery, feasibility, and acceptability from program beneficiaries, the interventionists, the interventionists' supervisors, and community stakeholders. The study will compare the trajectories of fidelity, competence, and self-efficacy between dashboard-supported delivery and standard delivery. The study will also include social network analysis to understand how the characteristics of networks comprised of supervisors and interventionists affect trajectories over time. Lastly, the study will investigate the impact of dashboard-supported delivery by comparing the difference in child and caregiver mental health outcomes with standard delivery. These data will be used to analyze cost-effectiveness and return on investment of the intervention as delivered with and without the Dashboard. The results of the proposed research will identify scalable pathways to accelerate integration of technology and evidence-based mental health services into policy and practice in Rwanda. Specific study aims and hypotheses are listed below: Aim 1: Conduct a Hybrid Type 3 implementation-effectiveness cluster randomized trial to compare Dashboard-supported delivery of Sugira Muryango to standard delivery in Kirehe District (12 sectors). * Aim 1.1: Compare competence and fidelity of IZUs' Sugira Muryango technology-enabled delivery compared to standard delivery. * Hypothesis 1.1: IZU competence and fidelity scores for Dashboard-supported delivery will be superior to standard delivery. * Aim 1:2: Investigate whether Dashboard-supported delivery affects IZU sustainment of evidence-based practices. * Hypothesis 1.2: Dashboard-supported delivery will improve IZU readiness to change and buy-in thereby moderating adoption and sustainment of evidence-based practices. Aim 2: Use social network analysis to examine cross-site learning-communications, knowledge flow, stakeholder interactions-across the PLAY Collaborative. The investigative team will compare sectors with and without Dashboard-supported delivery in Kirehe District. * Aim 2.1: Compare the structure of communication and knowledge networks between Dashboard-supported and standard delivery by examining key metrics of network size, density, and centrality. * Hypothesis 2.1: Technology-supported compared to standard delivery will have higher cross-site learning that is manifest in larger network size, density, and centrality measures. * Aim 2.2: Examine effects of supervisors' personal networks characteristics (network size, communication frequency, quality and content of interactions) on IZU fidelity, competence, and knowledge of mental health promotion. * Hypothesis 2.2: Personal network characteristics for supervisors (egos) and IZUs (alters/peers) will improve IZUs' competence, fidelity, internalized mental health knowledge, and self-efficacy. Aim 3: Leverage GoR infrastructure to examine whether technology-supported delivery increases Sugira Muryango impact, efficiency, and return-on-investment. Child and caregiver behavioral, child development, and family violence outcomes will be used to conduct incremental cost-effectiveness and return on investment analyses that evaluate benefits from a societal perspective. * Hypothesis 3.1: Dashboard-supported delivery will have superior effects on mental health, family violence, and child development outcomes compared with standard delivery. * Hypothesis 3.2: Dashboard-supported delivery will demonstrate greater efficiency (e.g., time-to-resolution of risk-of-harm cases of family mental health and violence). - Hypothesis 3.3: Technology-supported delivery will be cost-effective and provide value based on social returns criteria.

Conditions

Interventions

Type	Name	Description
OTHER	Digital Dashboard-Supported Sugira Muryango Implementation	Arm investigating technology-supported delivery of Sugira Muryango, specifically, the use of a Digital Dashboard tool developed in partnership with the University of Rwanda. Developed using co-design and user interface/user experience techniques, the Dashboard (a) streamlines collection of data on evidence-based intervention quality and reach; (b) improves visibility and searchability of implementation data by region; (c) facilitates caregiver mental health and social services referrals and follow up, and (d) serves as a training platform with resources to enhance lay worker fidelity (content-specific skills) and competence (cross-cutting skills) in evidence-based intervention delivery.
OTHER	Usual Care - Sugira Muryango Implementation	Sugira Muryango intervention is delivered using traditional supervision, data entry, and quality monitoring tools.

Timeline

Start date: 2025-01-30
Primary completion: 2027-06-30
Completion: 2029-05-31
First posted: 2025-04-24
Last updated: 2026-03-27

Locations

1 site across 1 country: Rwanda

Source: ClinicalTrials.gov record NCT06941831. Inclusion in this directory is not an endorsement.