Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 2, 2020
Date Accepted: Dec 10, 2020
mHealth Supported Delivery of an Evidence-based Family Home Visiting Intervention in Sierra Leone: A Pilot Randomized Controlled Trial Study Protocol
ABSTRACT
Background:
Past trauma and exposure to violence has been related to poor emotion regulation and household violence, which can have persistent mental health effects across generations. The Family Strengthening Intervention for Early Childhood Development (FSI-ECD/called Sugira Muryango in Rwanda) is an evidence-based behavioral home-visiting intervention to promote caregiver mental health, positive parenting practices, and early childhood development among families facing adversity. In Sierra Leone and other LMICS, mHealth technology has the potential to improve health care delivery and health outcomes.
Objective:
This study aims to: (a) apply user-centered design to develop and test mHealth tools to improve supervision and fidelity monitoring of community health workers (CHWs) delivering the FSI-ECD and (b) conduct a pilot randomized controlled trial of the FSI-ECD to assess feasibility, acceptability, and preliminary effects on caregiver mental health, emotion regulation, caregiving behaviors, and family violence in high risk families with children aged 6-36 months in comparison with control families receiving standard care.
Methods:
We will recruit and enroll CHWs, supervisors and families with a child aged 6-36 months in coordination with community health clinics in Makeni, Sierra Leone. CHWs and supervisors will participate in one problem-analysis focus group and two user interface/user experience (UI/UX) cycles to provide feedback on mHealth tool prototypes. Families will be randomized to mHealth supported FSI-ECD or standard maternal and child health services. We will collect quantitative data on caregiver mental health, emotion regulation, caregiving behaviors, and family functioning at baseline, post-intervention and 3-month follow-up. We will use a mixed-methods approach to explore feasibility and acceptability of mHealth tools and the FSI-ECD. Mixed effects linear modeling will assess FSI-ECD effects on caregiver outcomes. Cost-effectiveness analysis will estimate costs across FSI-ECD vs standard care.
Results:
Results will be reported after completion of the study protocol and analysis of data.
Conclusions:
This study will provide important data on the feasibility and acceptability of mHealth support tools for CHWs delivering an evidence-based family home visiting intervention in an LMIC and on the preliminary effects of the FSI-ECD on caregiver mental health, caregiving behaviors, violence reduction, and family functioning. Clinical Trial: Clinical trial registration number NCT04481399; registered on July 22, 2020.
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