An interventional study of Digital Dashboard-Supported Sugira Muryango Implementation and Usual Care - Sugira Muryango Implementation in IPV, Mental Health and Discipline Practices, sponsored by Boston College. Recruiting at 1 site in Rwanda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Boston College · Not applicable, Interventional, and Health services research
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.
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 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 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.
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Exclusion Criteria:
Sugira Muryango delivery using usual care data entry, supervision, and quality monitoring tools and protocols (paper forms, static data entry platform). Sugira Muryango is a home-visiting intervention that promotes playful parenting, father engagement, improved nutrition, care seeking, and family functioning to promote ECD, positive parent-child relationships, and healthy child development. Sugira Muryango integrates these core components into 12 modules and two booster/follow-up sessions (3 and 6-months after intervention).
Other: Usual Care - Sugira Muryango Implementation
Sugira Muryango delivery using a Digital dashboard aimed at improving data collection, monitoring, and usability, facilitating social services referrals, and interventionist supervision and training. Sugira Muryango is a home-visiting intervention that promotes playful parenting, father engagement, improved nutrition, care seeking, and family functioning to promote ECD, positive parent-child relationships, and healthy child development. Sugira Muryango integrates these core components into 12 modules and two booster/follow-up sessions (3 and 6-months after intervention).
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.
Sugira Muryango intervention is delivered using traditional supervision, data entry, and quality monitoring tools.
Risk of Harm cases time to resolution
Risk of harm cases' (violence, mental health) time to resolution in days.
Time frame: Through study completion, an average of 4 months
Intervention Quality of Delivery
Quality of delivery consists of fidelity, the ability to adhere intervention's planned activities, processes, and design, and competence, core interpersonal and professional skills relevant to mental health and psychosocial services interventions (i.e., empathy, active listening, rapport building). Fidelity is captured by intervention, session-specific items mapping planned activities and processes. Competence is capture by items mapping a set of cross-cutting interventionist skills that should be used or deployed during intervention delivery. Items are scored on a scale from 0 to 4. Scales scores are transformed and reported as percentages, with higher percentages representing higher fidelity and competence.
Time frame: Through study completion, an average of 4 months
IZU - interventionist self-efficacy (Adapted Provider Self-efficacy scale)
The Adapted Provider Self-efficacy scale measures providers' belief in ability to successfully perform specific tasks, make decisions, and deliver care. It captures confidence in the providers' skills, knowledge, and ability to manage clinical/intervention-related and interpersonal challenges effectively. Range 0-5, with higher values indicating higher self-efficacy.
Time frame: Through study completion, an average of 4 months
John Hopkins' Dissemination and Implementation Battery (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.
Time frame: Post-intervention, on average 4 months from baseline assessment.
The Implementation Leadership Scale (ILS)
This assessment assesses a key implementation science construct regarding leadership across 4 domains (proactive leadership, knowledgeable leadership, supportive leadership, perseverant leadership). The ILS includes 12-items scored on a 5-point Likert scale (0-4) with higher scores indicating stronger leadership.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
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.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Implementation Network Metrics and Characteristics
Data from supervisors, IZUs, and sector-level officials will be collected using an open-ended, name-generator relational network survey. Key outcomes and metrics include network-level (size, density, reciprocity, centralization, core-periphery indices) and actor-level measures (degree, closeness, and betweenness centrality). Implementation networks graphical representations will also be compared.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Rwanda Demographic Health Survey- Intimate Partner Violence
Indicators from the Rwanda DHS cover topics related to perpetration and victimization of violence between intimate partners.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Quality of Life (EQ-5D-3L)
The EQ-5D-3L is a standardized, self-reported questionnaire used to measure health-related quality of life/ The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Hopkin's Symptom Checklist (HSCL)
Assesses caregiver mental health including two subscales related to anxiety and depression. The HSCL includes 25 items scored on a 4-point Likert scale (1-4) scores can range from 1 to 100 with higher scores indicating poorer mental health. .
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Difficulties in Emotion Regulation (DERS)
Assesses caregiver emotion regulation. The full DERS scale includes 36 items which are scored on a 5-point Likert scale (1-5). Higher scores indicate greater difficulties in emotion regulation with a minimum score of 36 and maximum score of 180.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Trauma History and Post-Traumatic Stress Disorder (UCLA PTSD)
Is an evidence-based tool for assessing trauma exposure and symptoms of post-traumatic stress disorder. it includes separate modules for evaluating Trauma Exposure (nature and number of potentially traumatic events experienced or witnessed) and PTSD Symptoms (symptom inventory aligned with the diagnostic criteria for PTSD as defined in the DSM. The index is structured to assess key symptom clusters, such as re-experiencing, avoidance, negative alterations in cognition and mood, and hyperarousal. Scoring helps clinicians determine symptom severity and meet diagnostic criteria for PTSD.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
UNICEF MICS: Child Discipline Module
A key component of the Multiple Indicator Cluster Surveys (MICS), designed by UNICEF to collect internationally comparable data on child well-being. This module captures caregivers' disciplinary practices used with children aged 1-17 years, providing insights into the prevalence of both positive and negative disciplinary methods. Assesses caregiver's disciplinary practices in three domains: Non-violent discipline, Psychological Aggression, and Physical Punishment.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Gender Equitable Men (GEM) scale
Self-reported instrument that captures attitudes toward gender norms in intimate relationships or differing social expectations for men and women through two subscales: equitable and inequitable norms. The topics are on daily tasks and chores, relationships, health, and domestic violence. Scores range from 1-5 with higher scores representing higher gender equitable attitudes.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
WHO infant and young child feeding practices
Designed to gather information on breastfeeding and complementary feeding practices for children under the age of 2 years. This module aligns with guidelines established by the World Health Organization (WHO) to monitor child nutrition and inform programs aimed at improving feeding practices and reducing malnutrition among infants and young children. It assesses children's nutritional intake by parent-reported dietary intake reflecting the number of food groups (out of 7) the child consumed in the past 24 hours.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Observation of Caregiver-Child Interaction (OCCI)
A structured observational measure designed to assess the quality of interactions between mothers (or primary caregivers) and young children (6 months - 3 years) in a natural or semi-structured setting. This tool is primarily used in research and intervention programs to examine parenting practices, early child stimulation, and responsive caregiving.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
UNICEF MICS Family Care Indicators (FCI)
A set of measures included in the Multiple Indicator Cluster Surveys (MICS) to assess the extent to which children are receiving adequate care, stimulation, and support for their cognitive, emotional, and social development during early childhood. The early stimulation questions are caregivers' self-reported and captures engagement in stimulating activities (e.g., reading books, playing, counting, etc.) with the child during the prior three days.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
WASH Indicators - Rwanda Demographic and Health Survey (DHS)
The WASH Indicators in the Rwanda Demographic and Health Survey (DHS) refer to a set of measures designed to evaluate access to and the quality of Water, Sanitation, and Hygiene (WASH) services in households.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
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.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Preschool Self-Regulation Assessment (PSRA)
The Preschool Self-Regulation Assessment (PSRA) is a standardized tool designed to measure self-regulation skills in preschool-aged children. It is particularly used in early childhood research to assess children's emotional, attentional, and behavioral regulation abilities in structured settings. Scores range from 0 to 3, with higher scores representing higher self-regulation.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Home Observation for Measurement of the Environment (HOME) Inventory
The HOME is a 43-item survey to assess psychosocial stimulation in the households and includes items on responsive caregiving, language stimulation, personal-social development, stimulation materials in the house, among others. 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 psychosocial stimulation in the households.
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Infant Behavior Questionnaire / Early Childhood Behavior Questionnaire
Caregiver report of child's temperament, on three main domains: (1) Surgency/Extraversion (e.g., Vocal Reactivity, High Intensity Pleasure, Smiling and Laughter, Activity Level, and Perceptual Sensitivity); (2) Negative Affectivity (Sadness, Distress to Limitations, Fear, and Falling Reactivity/Rate of Recovery from Distress) and 3) Orienting/Regulation (Low Intensity Pleasure, Cuddliness, Duration of Orienting, and Soothability).
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
DHS/Promundo "Father Engagement & Financial Decision-Making" survey
Caregiver self-report of financial decision making and father engagement in child caretaking activities
Time frame: Baseline (Pre-intervention), 4-months (Post Intervention)
Plan to share: Yes — The study will share de-identified datasets, ensuring that all direct identifiers (DIs) are masked to protect participant confidentiality. These datasets will include relevant demographic information and outcome measures collected as part of the study. To facilitate ease of use and understanding, comprehensive codebooks and data dictionaries will also be made available, providing clear documentation of variables, coding schemes, and data definitions.
Supporting information: Study protocol, Statistical analysis plan
Time frame: NIMH timelines and submissions schedules will be followed to share the necessary information with potential users.
Access criteria: Study data and other relevant information will be made publicly available through the NIH National Data Archive system
Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 29 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
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