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

Boston College

Status: Completed

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

Treatments: Other: Community Health Worker Routine; Behavioral: Family Strengthening Intervention for Early Childhood Development

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04481399

R21MH124071 (U.S. NIH Grant/Contract)

21.006.01

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 6 months to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Focus Group-User Interface/User Experience (UI/UX) Participants: Individuals younger than age 18 and individuals who do not meet inclusion criteria.
• Family Participants: Families who do not meet all inclusion criteria and/or who are experiencing active family crises (e.g., current suicidality or psychosis, cognitive impairment, ongoing divorce process).
• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

FSI-ECD

Experimental group

Description:

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.

Treatment:

Behavioral: Family Strengthening Intervention for Early Childhood Development

Control

Other group

Description:

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.

Treatment:

Other: Community Health Worker Routine