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The Sugira Muryango PLAY Collaborative

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ClinicalTrials.gov Identifier: NCT04257383
Recruitment Status : Not yet recruiting
First Posted : February 6, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
FXB
Laterite
LEGO
Grand Challenges Canada
Echidna Giving
ELMA Philanthropies
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Information provided by (Responsible Party):
Theresa Betancourt, Boston College

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.

Condition or disease Intervention/treatment Phase
Child Development Parenting Parent-Child Relations Child Malnutrition Other: Sugira Muryango Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Our study works with Laterite to oversee data collection in the field. Laterite enumerators are blind to study condition and therefore do not know which study arm participants have been clustered and randomized into.
Primary Purpose: Prevention
Official Title: The PLAY Collaborative: Testing an Implementation Strategy for Scaling Out Evidence-Based ECD Home-Visiting in Rwanda
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Treatment
Families in the treatment cells will receive the Sugira Muryango treatment immediately after household identification and enrollment.
Other: Sugira Muryango
Strong Families, Thriving Children "Sugira Muryango" is a home-visiting intervention that empowers low-income families enrolled in Rwanda's social protection system to support early childhood development and healthy family functioning.

Experimental: Waitlist Control
Families in the control cells will receive the Sugira Muryango treatment following the completion of the 12-month follow up on the original treatment group.
Other: Sugira Muryango
Strong Families, Thriving Children "Sugira Muryango" is a home-visiting intervention that empowers low-income families enrolled in Rwanda's social protection system to support early childhood development and healthy family functioning.




Primary Outcome Measures :
  1. Home Observation for Measurement of the Environment (HOME) Inventory [ Time Frame: baseline, 4-months, 16-months ]
    The HOME is a 43-item survey to assess responsive caregiving. 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 responsive caregiving. Baseline will provide a baseline assessment of responsive caregiving while follow-up assessments will assess change over time.

  2. Observation of Mother-Child Interaction (OMCI) [ Time Frame: baseline, 4-months, 16-months ]
    The OMCI assesses responsive caregiving via a five-minute interaction that is scored according to published guidelines. The maximum OMCI score is 57 (minimum= 0) with higher scores indicating higher levels of responsive caregiving. Baseline will provide a baseline assessment of responsive caregiving while follow-up assessments will assess change over time.

  3. UNICEF MICS Family Care Indicators (FCI) [ Time Frame: baseline, 4-months, 16-months ]
    The UNICEF MICS Family Care Indicators is a cumulative score of caregivers' self-reported engagement in stimulating activities with the child during the prior three days. The maximum score is 6 (minimum score=0) with higher scores indicating higher levels of caregiver engagement in stimulating activities. Baseline will provide a baseline assessment of caregiver engagement while follow-up assessments will assess change over time.


Secondary Outcome Measures :
  1. Malawi Development Assessment Tool (MDAT) [ Time Frame: baseline, 4-months, 16-months ]
    The MDAT is an observational, task-based measure used to asses child development across domain of gross motor, fine motor, language and socio-emotional development. Standardization of score is done relative to data from the SHINE study from Malawi provided by the MDAT team. Baseline will provide a baseline assessment of child development while follow-up assessments will assess change over time.

  2. Ages and Stages Questionnaire-3 (ASQ-3) [ Time Frame: baseline, 4-months, 16-months ]
    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. Baseline will provide a baseline assessment of child development while follow-up assessments will assess change over time.

  3. UNICEF MICS: Child Discipline Module [ Time Frame: baseline, 4-months, 16-months ]
    Assesses children's exposure to violent and nonviolent discipline. Exposure to violence is assessed by summing the exposures and creating a continuous score that can range from 0 to 13. Baseline will provide a baseline assessment of child discipline while follow-up assessments will assess change over time.

  4. Rwanda Demographic and Health Survey (DHS) [ Time Frame: baseline, 4-months, 16-months ]
    Indicators from the Rwanda DHS cover topics related to child health, care seeking, WASH (Water, Sanitation, Hygiene), and intimate partner violence. All responses are binary (yes/no). Baseline will provide a baseline assessment of child health while follow-up assessments will assess change over time.

  5. WHO infant and young child feeding practices [ Time Frame: baseline, 4-months, 16-months ]
    This assessment assesses children's nutritional intake was assessed by parent-reported dietary diversity reflecting the number of food groups (out of 7) the child consumed in the past 24 hours. Scores are binary (yes/no) and a sum score is created to indicate dietary diversity; minimum score is 0 and a maximum score in 14. Baseline will provide a baseline assessment of dietary diversity and nutrition while follow-up assessments will assess change over time.

  6. Child Anthropometrics [ Time Frame: baseline, 4-months, 16-months ]
    Child anthropometrics are assessed by taking child's height, weight, length and a measure of the middle-upper arm circumference. Height is measured in centimeters to the nearest 0.1 cm. Weight is measured in kilograms to the nearest 1 gram. Middle upper arm circumference is measured in centimeters to the nearest 0.1 cm. Standardization is done using software provided by the World Health Organization. Baseline will provide a baseline assessment of child height/weight/growth while follow-up assessments will assess change over time.


Other Outcome Measures:
  1. Hopkin's Symptom Checklist (HSCL) [ Time Frame: baseline, 4-months, 16-months ]
    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. Baseline will provide a baseline assessment of caregiver mental health while follow-up assessments will assess change over time.

  2. Difficulties in Emotion Regulation (DERS) [ Time Frame: baseline, 4-months, 16-months ]
    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. Baseline will provide a baseline assessment of caregiver mental health (emotion dysregulation) while follow-up assessments will assess change over time.

  3. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: baseline, 4-months, 16-months ]
    Assesses caregiver interpersonal functioning across 6 domains (cognition, mobility, self-care, getting along, life activities, participation). The WHODAS 2.0 includes 12 items scored on a 5-point Likert scale (0-4) where scores can range from 0 to 48. Higher scores indicate worse interpersonal functioning. Baseline will provide a baseline assessment of caregiver interpersonal functioning while follow-up assessments will assess change over time.

  4. Dissemination and Implementation Measure (D&I) [ Time Frame: baseline and 4-months ]
    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. Baseline will provide a baseline assessment of these constructs while follow-up assessments will assess change over time.

  5. Program Sustainability Assessment Tool (PSAT) [ Time Frame: baseline and 4-months ]
    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 will provide a baseline assessment of program sustainability while follow-up assessments will assess change over time.

  6. The Implementation Leadership Scale (ILS) [ Time Frame: baseline and 4-months ]
    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 will provide a baseline assessment of leadership as it regards evidence-based practice while follow-up assessments will assess change over time.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257383


Contacts
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Contact: Jordan Farrar 2028349118 farrarjb@bc.edu

Locations
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Rwanda
FXB Rwanda
Kigali, Rwanda
Sponsors and Collaborators
Boston College
FXB
Laterite
LEGO
Grand Challenges Canada
Echidna Giving
ELMA Philanthropies
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Investigators
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Principal Investigator: Theresa Betancourt, Sc.D Boston College School of Social Work
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Responsible Party: Theresa Betancourt, Salem Professor in Global Practice, Boston College
ClinicalTrials.gov Identifier: NCT04257383    
Other Study ID Numbers: 001210997
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Nutrition Disorders