Clinical trial NCT06941831: Rwanda Digital Dashboard Hybrid Type 3 Implementation Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IPV
Mental Health
Discipline Practices
Quality Assurance
Provider Confidence
Provider Skill
Quality of Life
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-24
Enrollment: 1810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Household inclusion criteria: Participants must be the primary caregiver to a child between birth and 36 months. Caregivers must live in the same household as the child and must be the child's legal guardian. Legal guardians may be parents, aunts, uncles, grandparents, or foster parents. Participants must be categorized as Ubudehe 1 under the socio-economic categorization of households from LODA.
* Government Official inclusion criteria: Government officials must be located at the Village, Cell, Sector and/or District level and must participate in the 1-day ECD training. Government officials must also agree to participate in the PLAY Collaborative activities throughout the course of program delivery.
* IZU interventionist inclusion criteria: IZUs must be a part of the Inshuti z'Umuryango/Friends of the Family program, must be over the age of 18, and must be literate in Kinyarwanda.
* Cell Level IZU Mentor inclusion criteria: Cell Level IZU Coordinators must be situated at the Cell Level and able to supervise at least 12 IZU interventionists, must be over 18 years of age, and must be literate in Kinyarwanda.

Exclusion Criteria:

* Household exclusion criteria: Potential participants will be excluded if they do not meet the inclusion criteria above, are experiencing an active crisis (e.g., psychosis), or have severe cognitive impairments which preclude their ability to speak to the research questions/assessments under scrutiny.
* Government Official exclusion criteria: Government officials will be excluded from participation in the PLAY Collaborative if they are not located at the Cell, Sector or District level and if they are unable to meet the demands of participation in the PLAY Collaborative.
* IZU interventionist exclusion criteria: IZUs will be excluded from participation if they do not meet the inclusion criteria above and if they are unable to meet the demands of delivering the Sugira Muryango program.
* Cell Level IZU Mentor exclusion criteria: Cell Level IZU Coordinators will be excluded if they do not meet the inclusion criteria above or are unable to meet the demands of supporting the delivery of the Sugira Muryango program.

Primary outcomes:
measure: Risk of Harm cases time to resolution
timeFrame: Through study completion, an average of 4 months
measure: Intervention Quality of Delivery
timeFrame: Through study completion, an average of 4 months
measure: IZU - interventionist self-efficacy (Adapted Provider Self-efficacy scale)
timeFrame: Through study completion, an average of 4 months
measure: John Hopkins' Dissemination and Implementation Battery (D&I)
timeFrame: Post-intervention, on average 4 months from baseline assessment.
measure: The Implementation Leadership Scale (ILS)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Program Sustainability Assessment Tool (PSAT)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Implementation Network Metrics and Characteristics
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Rwanda Demographic Health Survey- Intimate Partner Violence
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Quality of Life (EQ-5D-3L)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
Secondary outcomes:
measure: Hopkin's Symptom Checklist (HSCL)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Difficulties in Emotion Regulation (DERS)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Trauma History and Post-Traumatic Stress Disorder (UCLA PTSD)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: UNICEF MICS: Child Discipline Module
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Gender Equitable Men (GEM) scale
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: WHO infant and young child feeding practices
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Observation of Caregiver-Child Interaction (OCCI)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: UNICEF MICS Family Care Indicators (FCI)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
Other outcomes:
measure: WASH Indicators - Rwanda Demographic and Health Survey (DHS)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Ages and Stages Questionnaire-3 (ASQ-3)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Preschool Self-Regulation Assessment (PSRA)
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Home Observation for Measurement of the Environment (HOME) Inventory
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: Infant Behavior Questionnaire / Early Childhood Behavior Questionnaire
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
measure: DHS/Promundo "Father Engagement & Financial Decision-Making" survey
timeFrame: Baseline (Pre-intervention), 4-months (Post Intervention)
Locations:
city: Kigali
country: Rwanda
facility: FXB-Rwanda / 2XHQ+F2G Umerenge wa Runda, Runda, Rwanda
Study officials:
affiliation: Boston College Research Program on Children and Adversity
name: Theresa S Betancourt, MA, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Public-Private Infrastructure Advisory Facility. Rwanda: Optimization of the KTRN national fiber backbone and 4G network. Published online April 1, 2019
citation: Desmond C, Watt KG, Jensen SKG, Simmons E, Murray SM, Farrar J, Placencio-Castro M, Sezibera V, Rawlings LB, Wilson B, Betancourt TS. Measuring the cost-effectiveness of a home-visiting intervention to promote early child development among rural families linked to the Rwandan social protection system. PLOS Glob Public Health. 2023 Oct 24;3(10):e0002473. doi: 10.1371/journal.pgph.0002473. eCollection 2023.
citation: Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6.
citation: 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.
citation: Aarons GA, Fettes DL, Hurlburt MS, Palinkas LA, Gunderson L, Willging CE, Chaffin MJ. Collaboration, negotiation, and coalescence for interagency-collaborative teams to scale-up evidence-based practice. J Clin Child Adolesc Psychol. 2014;43(6):915-28. doi: 10.1080/15374416.2013.876642. Epub 2014 Mar 10.
citation: Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.
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.
citation: Betancourt TS, Thomson D, VanderWeele TJ. War-Related Traumas and Mental Health Across Generations. JAMA Psychiatry. 2018 Jan 1;75(1):5-6. doi: 10.1001/jamapsychiatry.2017.3530. No abstract available.
citation: Jensen SKG, Sezibera V, Murray SM, Brennan RT, Betancourt TS. Intergenerational impacts of trauma and hardship through parenting. J Child Psychol Psychiatry. 2021 Aug;62(8):989-999. doi: 10.1111/jcpp.13359. Epub 2020 Dec 7.
citation: Betancourt TS, Williams TP, Kellner SE, Gebre-Medhin J, Hann K, Kayiteshonga Y. Interrelatedness of child health, protection and well-being: an application of the SAFE model in Rwanda. Soc Sci Med. 2012 May;74(10):1504-11. doi: 10.1016/j.socscimed.2012.01.030. Epub 2012 Mar 9.
citation: Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.