Desrosiers 2021.

Study name	mHealth‐supported delivery of an evidence‐based family home‐visiting intervention in Sierra Leone: protocol for a pilot randomized controlled trial
Methods	Study design: RCT Country: Sierra Leone
Participants	Families with a child aged 6‐36 months Inclusion criteria:  a. Sierra Leonean household with cohabitating caregivers (e.g. father/mother, mother/grandmother, mother/partner) and child (aged 6‐36 months) with both caregivers aged 18 or older; b. 1 caregiver scoring at least 62.5 on the Difficulties in Emotion Regulation Scale (DERS). Both caregivers must agree to attend FSI‐ECD sessions; however, if 1 caregiver decides to withdraw, the family can still continue to participate. If enrolled families have more than 1 child aged 6‐36 months, we will include all eligible children as study participants. Exclusion criteria: a. families who do not meet all inclusion criteria; b. families who experience active family crises (e.g. current suicidality or psychosis, serious medical condition, or cognitive impairment as assessed by a study social worker). Stated purpose: to (1) apply a user‐centred design to develop and test mHealth tools to improve supervision and fidelity monitoring of community health workers (CHWs) delivering the FSI‐ECD and (2) conduct a pilot randomized controlled trial of the FSI‐ECD to assess feasibility, acceptability, and preliminary effects on caregiver mental health, emotion regulation, caregiving behaviours, and family violence in high‐risk families with children aged 6‐36 months in comparison with control families receiving standard care
Interventions	Intervention: Family Strengthening Intervention for Early Childhood Development (FSI‐ECD/called Sugira Muryango in Rwanda) The FSI‐ECD is composed of 4 core components: (1) developing problem‐solving, stress management, and emotion regulation skills; (2) cultivating positive parenting skills and fostering father/male co‐caregiver engagement; (3) developing communication and conflict resolution skills; and (4) exploring alternatives to harsh punishment and practising nonviolent child discipline. The FSI‐ECD is delivered in 12 modules in the home via coaching by CHWs. Sessions are delivered once per week and last approximately 90 minutes. Control: Usual care (standard CHW care involves 3 home‐visiting, educational sessions delivered to families following childbirth, with weekly supervision via phone or face‐to‐face. Topics of home‐visiting sessions include skilled postnatal care for mothers, early initiation of breastfeeding, nutrition, immunization services, handwashing and hygiene practices, building the capacity of family members to take care of newborns and children under age 5)
Outcomes	Participants'outcomes of interest for this review Mental health symptoms – Hopkins Symptom Checklist (HSCL) Psychological functioning and impairment (emotion regulation) – Difficulties in Emotion Regulation Scale (DERS) Psychological functioning and impairment – WHO Disability Assessment Schedule Mental health symptoms/distress/PTSD – Post‐traumatic Stress Disorder Reaction Index Economic outcomes Preliminary cost‐effectiveness analysis to assess the economic value of the mHealth‐supported delivery of the FSI‐ECD versus standard care with standard supervision Time points: baseline, post‐intervention (immediate post‐intervention and 3 months follow‐up)
Starting date	15 December 2020
Contact information	Alethea Desrosiers, alethea.desrosiers@bc.edu
Notes	Source of funding: National Institutes of Mental Health Prospective trial registration number: NCT04481399