Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-05

Study Completion Date

2023-08-16

Brief Summary

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This study will pilot a family-focused, behavioral health intervention while also developing and piloting mHealth tools to support Community Health Workers (CHWs) in Sierra Leone. This dual focus will help build capacity both for delivery of evidence-based mental health services to reduce family violence and harsh parenting practices, and for effective use of mHealth strategies to improve healthcare delivery quality. This study will leverage Government of Sierra Leone investments in community health initiatives as a strategy to address critical healthcare workforce limitations that plague delivery of evidence-based interventions to vulnerable families in post-conflict Sierra Leone. Study aims are to:

Aim 1. Employ a five-phase user-centered design approach to develop and test mHealth tools to improve training, supervision, and fidelity monitoring of Community Health Workers. Study investigators hypothesize that mHealth tools will be feasible, acceptable, and user-friendly.

Aim 2. Conduct a Randomized Controlled Pilot Study to assess feasibility, acceptability, costs and preliminary effects of the mHealth-supported delivery of FSI-ECD on parent mental health, emotion regulation, and familial violence in high risk families with children aged 6-36 months (n=40) in comparison to control families (n=40) who receive standard care. Parental mental health, emotion regulation, household violence, and parenting practices will be assessed at baseline, post-intervention and 6-month follow-up. Study investigators hypothesize that (a) the effects of the FSI-ECD will be comparable to results observed with vulnerable families in Rwanda; (b) digital tools will be feasible and acceptable to CHWs and supervisors.

Aim 3. Leverage well-established relationships and government partners to strengthen capacity for mHealth research and quality healthcare delivery in Sierra Leone. Partners include the University of Makeni, the Directorate of Science, Technology and Innovation, and the Ministry of Health and Sanitation.

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Detailed Description

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Conditions

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Parent-Child Relations Behavioral Intervention Exposure to Violent Event Child Development Mental Health Implementation Science mHealth Community Health Workers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FSI-ECD

The Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. The FSI-ECD will be delivered in weekly 90-minute home visiting sessions for 12 consecutive weeks.

Group Type EXPERIMENTAL

Family Strengthening Intervention for Early Childhood Development

Intervention Type BEHAVIORAL

The Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. FSI-ECD compromises five core components delivered in 12 modules delivered in weekly sessions via active coaching by community health workers. Core components include coaching on: a) nutrition, health and hygiene; b) early stimulation and playful parenting; c) building resilience and coping skills; d) building problem-solving skills; and d) building emotion regulation and conflict resolution skills.

Control

The control is standard maternal and child health home visiting delivered by community health workers. Families will receive three 90-minute home visiting educational sessions focused on nutrition, hygiene, and post-natal care.

Group Type OTHER

Community Health Worker Routine

Intervention Type OTHER

Standard CHW care involves three home visiting sessions delivered to families following childbirth with weekly supervision via phone or face-to-face. Topics of home visiting sessions include: skilled post-natal care for mothers, early initiation of breastfeeding and exclusive breastfeeding practices, adequate nutrition, immunization services and timely use of these services, hand washing and hygiene practices (including waste disposal and food hygiene), building the capacity of family members to appropriately take care of newborns and children under age 5, and building the capacity of family members to recognize and act on postnatal danger signs for newborns, mothers, and children under 5. CHWs also conduct screenings for acute malnutrition and growth monitoring to identify early referrals, and they can provide family planning methods, deworming tablets and other vitamins for acute malnutrition, dehydration, and anti-malaria treatment. Each home-visiting session lasts about 60 minutes.

Interventions

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Family Strengthening Intervention for Early Childhood Development

The Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. FSI-ECD compromises five core components delivered in 12 modules delivered in weekly sessions via active coaching by community health workers. Core components include coaching on: a) nutrition, health and hygiene; b) early stimulation and playful parenting; c) building resilience and coping skills; d) building problem-solving skills; and d) building emotion regulation and conflict resolution skills.

Intervention Type BEHAVIORAL

Community Health Worker Routine

Standard CHW care involves three home visiting sessions delivered to families following childbirth with weekly supervision via phone or face-to-face. Topics of home visiting sessions include: skilled post-natal care for mothers, early initiation of breastfeeding and exclusive breastfeeding practices, adequate nutrition, immunization services and timely use of these services, hand washing and hygiene practices (including waste disposal and food hygiene), building the capacity of family members to appropriately take care of newborns and children under age 5, and building the capacity of family members to recognize and act on postnatal danger signs for newborns, mothers, and children under 5. CHWs also conduct screenings for acute malnutrition and growth monitoring to identify early referrals, and they can provide family planning methods, deworming tablets and other vitamins for acute malnutrition, dehydration, and anti-malaria treatment. Each home-visiting session lasts about 60 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Focus Group-User Interface/User Experience (UI/UX) Participants: Aged 18 or older; ability to attend 1-2 sessions (90 minutes per session)
* Family Participants: Families who are (a) a Sierra Leonean household with cohabitating caregivers (e.g., father/mother, mother/grandmother, mother/intimate partner), and child (aged 6-36 months) with both parents aged 18 or older and; (b) one parent scoring at least 62.5 on the Difficulties in Emotion Regulation Scale (DERS). The DERS cut-off score has been used successfully as a risk assessment screening tool in our prior and ongoing studies in Sierra Leone. Sierra Leonean caregivers scoring above this threshold on the DERS have reported significantly higher levels of severe physical punishment with their children as well as intimate partner violence. Both parents must agree to attend FSI-ECD sessions. If enrolled families have more than one child aged 6-36 months, we will include all eligible children as study participants.
* Community Health Worker Participants: CHWs who are 18 years or older and who are assigned to the Peripheral Health Unit that provides health services in one of our target communities.
* Community Health Worker Supervisor Participants: Supervisors are 18 years or older and oversee CHWs providing maternal and child health services

* Community Health Worker Participants: Individuals under age 18 cannot be recruited to work as a CHW.
* Community Health Worker Supervisor Participants: Individuals under age 18.

Minimum Eligible Age

6 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes