Rwanda Digital Dashboard Hybrid Type 3 Implementation Study

NCT06941831 | Recruiting DMC

• 2 other identifiers: 5116621R01MH136200
• Study Type: interventional
• Target: 1,810
• Locations: 1 country
• Sites: 1

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.

Conditions

IPV; Discipline Practices; Quality Assurance; Provider Confidence; Provider Skill; Quality of Life; Mental Health

Outcome Measures

Primary Outcomes (9)

• Risk of Harm cases time to resolution

  Risk of harm cases' (violence, mental health) time to resolution in days.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline (Pre-intervention), 4-months (Post Intervention)

Secondary Outcomes (8)

• Hopkin's Symptom Checklist (HSCL)

  Baseline (Pre-intervention), 4-months (Post Intervention)

• Difficulties in Emotion Regulation (DERS)

  Baseline (Pre-intervention), 4-months (Post Intervention)

• Trauma History and Post-Traumatic Stress Disorder (UCLA PTSD)

  Baseline (Pre-intervention), 4-months (Post Intervention)

• UNICEF MICS: Child Discipline Module

  Baseline (Pre-intervention), 4-months (Post Intervention)

• Gender Equitable Men (GEM) scale

  Baseline (Pre-intervention), 4-months (Post Intervention)

Other Outcomes (6)

• WASH Indicators - Rwanda Demographic and Health Survey (DHS)

  Baseline (Pre-intervention), 4-months (Post Intervention)

• Ages and Stages Questionnaire-3 (ASQ-3)

  Baseline (Pre-intervention), 4-months (Post Intervention)

• Preschool Self-Regulation Assessment (PSRA)

  Baseline (Pre-intervention), 4-months (Post Intervention)

Study Arms (2)

Usual Care Sugira Muryango Implementation

ACTIVE COMPARATOR

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

Digital Dashboard Supported

EXPERIMENTAL

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

Interventions

Usual Care - Sugira Muryango Implementation OTHER

Sugira Muryango intervention is delivered using traditional supervision, data entry, and quality monitoring tools.

Usual Care Sugira Muryango Implementation

Digital Dashboard-Supported Sugira Muryango Implementation OTHER

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.

Digital Dashboard Supported

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Boston College: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

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

Kigali, Kigali, Rwanda

RECRUITING

Related Publications (11)

• Public-Private Infrastructure Advisory Facility. Rwanda: Optimization of the KTRN national fiber backbone and 4G network. Published online April 1, 2019

  BACKGROUND

• 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.

  PMID: 37874790 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32375840 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33284991 BACKGROUND

• 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.

  PMID: 22459187 BACKGROUND

• 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.

  PMID: 17132052 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Theresa S Betancourt, MA, Sc.D.

  Boston College Research Program on Children and Adversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren J Pisani, PhD

CONTACT

617-552-8397; pisanila@bc.edu

Emmanuel J KAYITANA

CONTACT

+(250) 780 925 908; ekayitana@fxb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 24, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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

Locations

RW (1)