Rwanda Digital Dashboard Hybrid Type 3 Implementation Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 foll
• Другое Usual Care - Sugira Muryango Implementation
  Sugira Muryango intervention is delivered using traditional supervision, data entry, and quality monitoring tools.

Первичные конечные точки

• Risk of Harm cases time to resolution [Срок оценки: Through study completion, an average of 4 months]
• Intervention Quality of Delivery [Срок оценки: Through study completion, an average of 4 months]
• IZU - interventionist self-efficacy (Adapted Provider Self-efficacy scale) [Срок оценки: Through study completion, an average of 4 months]
• John Hopkins' Dissemination and Implementation Battery (D&I) [Срок оценки: Post-intervention, on average 4 months from baseline assessment.]
• The Implementation Leadership Scale (ILS) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Program Sustainability Assessment Tool (PSAT) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Implementation Network Metrics and Characteristics [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Rwanda Demographic Health Survey- Intimate Partner Violence [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Quality of Life (EQ-5D-3L) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]

Вторичные конечные точки (8)

• Hopkin's Symptom Checklist (HSCL) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Difficulties in Emotion Regulation (DERS) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Trauma History and Post-Traumatic Stress Disorder (UCLA PTSD) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• UNICEF MICS: Child Discipline Module [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Gender Equitable Men (GEM) scale [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• WHO infant and young child feeding practices [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• Observation of Caregiver-Child Interaction (OCCI) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]
• UNICEF MICS Family Care Indicators (FCI) [Срок оценки: Baseline (Pre-intervention), 4-months (Post Intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Rwanda · 1 центр

• FXB-Rwanda / 2XHQ+F2G Umerenge wa Runda, Runda, Rwanda — Kigali

Публикации

• Public-Private Infrastructure Advisory Facility. Rwanda: Optimization of the KTRN national fiber backbone and 4G network. Published online April 1, 2019
• 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. eCollecti PMID 37874790
• 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. PMID 30611302
• 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 PMID 32375840
• 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. PMID 24611580
• 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. PMID 21197565
• 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. PMID 33514591
• 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. PMID 29188290

Идентификаторы

NCT: NCT06941831 · 5116621 · R01MH136200

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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