Clinical trial NCT04257383: The Sugira Muryango PLAY Collaborative
Official title: The PLAY Collaborative: Testing an Implementation Strategy for Scaling Out Evidence-Based ECD Home-Visiting in Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Parenting
Parent-Child Relations
Child Malnutrition
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: FXB
name: Laterite
name: LEGO
name: Grand Challenges Canada
name: Echidna Giving
name: The ELMA Foundation
name: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
First posted: 2020-02-06
Enrollment: 1333
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study design consists of a two-arm cluster randomized control trial (CRT), which will span approximately 36 cells in 3 districts of Rwanda to compare outcomes among VUP eligible households with at least one child birth-36 months old in the following study arms: treatment and waitlist control. For the embedded quasi experimental study, we aim to enroll 540 households. These households will be assessed at baseline (pre-intervention), midline (post-intervention) and endline (12-months follow-up).
Primary purpose: PREVENTION

Brief summary: The Research Program on Children and Adversity (RPCA) has successfully grown its evidence-based home-visiting program-Sugira Muryango (SM)-in Rwanda, as policies and programs aligned with the Rwandan social protection system have evolved. The current study submission seeks to test an evidence-based implementation strategy, the PLAY Collaborative, to engage local stakeholders and frontline providers and supervisors to ensure quality improvement and sustainability of Sugira Muryango and to repeat our previous intervention to include Ubudehe 1 families with children 0-36 months in Nyanza, Ngoma, and Rubavu Districts in Rwanda.

Detailed description: The Research Program on Children and Adversity (RPCA) has successfully grown its evidence-based home-visiting program-Sugira Muryango-in Rwanda, as early childhood development (ECD) policies and programs have evolved. The combination of ECD commitment by the government and the proven Sugira Muryango intervention creates an ideal environment for further collaboration between RPCA and families at-risk of interpersonal violence, malnutrition, and other factors crucial to successful development of children. Sugira Muryango was designed as a complement to other center and community-based ECD interventions in Rwanda that may not adequately address issues such as limited stimulation in the home, hygiene, nutrition, father engagement, and violence in the home which is more prevalent among families living in extreme poverty.

Sugira Muryango is a home-visiting model to support playful parenting, father engagement, improved nutrition, care seeking and family functioning-to promote ECD, positive parent-child relationships, and healthy child development. The intervention (a) builds playful parenting skills and improves knowledge of ECD to create a safe, stimulating and nourishing environment for the growth of young children with a focus on nutrition, health and hygiene promotion; (b) coaches parents of young children in "serve and return" interactions and playful parenting; (c) develops a "family narrative" to build hope and highlight sources of resilience for addressing challenges and reducing risk of violence; (d) strengthens problem-solving skills as well as the navigation of formal and informal community resources; and, (e) builds skills in parental emotion regulation and alternatives to harsh punishment. Sugira Muryango integrates these core components, informed by the WHO Care for Child Development package, into 12 modules and two booster/follow-up sessions. The 60-90 minute modules are delivered weekly over 3-4 months by well-trained lay interventionists embedded in the community referred to as IZUs.

The Sugira Muryango intervention has been demonstrated as clinically effective due to its theory of change, its evidence-based curriculum, and its implementation science approach. To date, RPCA's implementation science strategies have focused on: 1) determining fidelity to curriculum content and delivery and developing strategies for quality improvement; 2) evaluating how features of program delivery moderate or mediate outcomes on children and families; and 3) identifying evidence-based practices pertaining to delivery, supervision and monitoring to support a systems level scaling-up of the program. Sustainment and scaling of Sugira Muryango requires strong local buy-in and government commitment. We plan to achieve this by evaluating a new implementation science strategy-a Collaborative Team Approach (CTA), drawn from evidence-based practices in implementation science described in this project as the "PLAY Collaborative". A key feature of the PLAY Collaborative to transition the evidence-based Sugira Muryango to ownership by local stakeholders is the development of a cross-site Seed Team that will assume a leadership role in ongoing training, supervision and fidelity across a regional set of IZU interventionists. As the in-country Sugira Muryango expert, with a strong presence in our target districts, François Xavier Bagnoud (FXB)-Rwanda (hereafter FXB) will staff and lead the development and activities of the Seed Team. FXB-Rwanda has been awarded a grant from Grand Challenges Canada to start the development of the Seed Team in Nyanza district, so it will be mature and well developed to expand to all three districts under the LEGO Foundation Hybrid Type II Implementation-Effectiveness Trial. In the PLAY Collaborative strategy being evaluated therein, the Seed Team comprising Sugira Muryango experts with ECD and family violence prevention experience, will be employed by FXB and physically based near and linked to IZUs at the village level. The Seed Team will work across our three target districts to oversee Sugira Muryango delivery while establishing regional teams of IZU interventionists, Cell Coordinators and Sector Associate Trainers to embed the SM practice in the community.

By developing local expertise through regional collaborative teams, and a Seed Team that shifts ownership to local partners for training and ongoing supervision, cross-site learning, dissemination and sustainability are enhanced. The PLAY Collaborative is modeled after the Interagency Collaborative Team model utilized by Dr. Gregory Aarons in scaling up the SafeCare intervention for families involved in or at-risk for involvement in the child welfare system in the United States. Through this work, collaboration emerged as a key element for the implementation and sustainment of evidence-based practices into established service delivery systems. Within the PLAY Collaborative, collaboration primarily involves in-country Sugira Muryango experts (FXB), ECD stakeholders (NCC, NECDP, MIGEPROF), Sector Associate Trainers, Cell Mentors, and service providers (IZU interventionists). This model is uniquely aligned to sustain and scale the evidence-based SM ECD home-visiting intervention as reliance on remote expertise in low resource settings is neither feasible nor sustainable.

Two main activities will be conducted:

1. To replicate the Sugira Muryango intervention while expanding the target population and the children's age, to all Ubudehe 1 families with children between birth and 36 months in Nyanza, Ngoma, and Rubavu districts.
2. To Evaluate the implementation strategy of the PLAY collaborative and its relation to Intervention effectiveness.

Our specific hypotheses are as follows:

1. Intervention effectiveness:

   1. The updated Sugira Muryango intervention, delivered by a government-supported community volunteer workforce, will lead to improvements in responsive parent-child relationships, improved child development and reduced violence.
   2. The updated Sugira Muryango intervention will lead to improvements in caregiver behaviors that support child health including increased care seeking for illness, improved hygiene, and improved dietary diversity as well as improvements in observed child health outcomes related to child growth and illness.
2. Implementation via the Play Collaborative:

   1. Engagement and buy-in of the PLAY Collaborative will strengthen dissemination and implementation of Sugira Muryango.
   2. High fidelity to Sugira Muryango core components will enhance Sugira Muryango clinical effectiveness and improve caregiver and child outcomes.
   3. Implementation science constructs related to acceptability, feasibility, and appropriateness will be strongly and positively correlated with program satisfaction.

The effectiveness trial to evaluate the expanded Sugira Muryango program delivered within the PLAY collaborative (which targets 10,000 households across three study districts) will utilize a Hybrid Type 2 Effectiveness-Implementation study design. This design blends components of a clinical effectiveness trial with implementation science research methodology (Curran et. al, 2012). The blending of these two lines of research has several advantages over pursuing each line of research independently including more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This Hybrid Type 2 Effectiveness-Implementation Design trial will utilize the EPIS conceptual model which guides the anticipation, identification, and response to common issues when transitioning evidence-based practices to larger delivery systems such as those in the public sector where they can have the most impact.

A quasi-experitmental design with randomization at the village level will be used such that each village will either receive the treatment or care as usual, which will help in avoiding the risk of diffusion of the treatment (i.e., treatment families sharing practices learned with others who did not receive the treatment). Both quantitative and qualitative data will be collected in three timepoints (baseline, post-intervention, and 12-months follow-up) by local research assistants blind to site and family condition assignments to investigate implementation processes and impact of the Sugira Muryango intervention at multiple levels: family level, interventionist level, supervisor level, and district level.

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, they 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: Home Observation for Measurement of the Environment (HOME) Inventory
timeFrame: baseline, 4-months, 16-months
measure: Observation of Mother-Child Interaction (OMCI)
timeFrame: baseline, 4-months, 16-months
measure: UNICEF MICS Family Care Indicators (FCI)
timeFrame: baseline, 4-months, 16-months
measure: Dissemination and Implementation Measure (D&I)
timeFrame: baseline and 4-months
measure: Program Sustainability Assessment Tool (PSAT)
timeFrame: baseline and 4-months
measure: Malawi Development Assessment Tool (MDAT)
timeFrame: baseline, 4-months, 16-months
measure: Ages and Stages Questionnaire-3 (ASQ-3)
timeFrame: baseline, 4-months, 16-months
measure: UNICEF MICS: Child Discipline Module
timeFrame: baseline, 4-months, 16-months
measure: Rwanda Demographic Health Survey- Intimate Partner Violence
timeFrame: baseline, 4-months, 16-months
Secondary outcomes:
measure: Rwanda Demographic and Health Survey (DHS)
timeFrame: baseline, 4-months, 16-months
measure: WHO infant and young child feeding practices
timeFrame: baseline, 4-months, 16-months
measure: Child Anthropometrics
timeFrame: baseline, 4-months, 16-months
Other outcomes:
measure: Hopkin's Symptom Checklist (HSCL)
timeFrame: baseline, 4-months, 16-months
measure: Difficulties in Emotion Regulation (DERS)
timeFrame: baseline, 4-months, 16-months
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: baseline, 4-months, 16-months
measure: The Implementation Leadership Scale (ILS)
timeFrame: baseline and 4-months
Locations:
city: Kigali
country: Rwanda
facility: FXB Rwanda
Study officials:
affiliation: Boston College School of Social Work
name: Theresa Betancourt, Sc.D
role: PRINCIPAL_INVESTIGATOR
References: