Clinical trial NCT04481399: Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention
Official title: mHealth Tools to Improve Service Delivery Quality of an Evidence-Based Family Home Visiting Intervention to Prevent Family Violence Among High Risk Families in Sierra Leone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Behavioral Intervention
Exposure to Violent Event
Child Development
Mental Health
Implementation Science
mHealth
Community Health Workers
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: Caritas Freetown
name: National Institute of Mental Health (NIMH)
First posted: 2020-07-22
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale
timeFrame: Immediately after the intervention
measure: Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, immediately after the intervention, and 3-months after the intervention
measure: Conflict Tactics Scale-2 (CTS-2)
timeFrame: Baseline, immediately after the intervention, and 3-months after the intervention
measure: Home Observation for Measurement of the Environment (HOME)
timeFrame: Baseline, immediately after the intervention, and 3-months after the intervention
measure: Observation of Mother-Child Interaction (OMCI)
timeFrame: Baseline, immediately after the intervention, and 3-months after the intervention
measure: Hopkins Symptom Checklist (HSCL)
timeFrame: Baseline, immediately after the intervention and 3-months after the intervention
measure: Post-traumatic Stress Disorder Civilian Checklist
timeFrame: Baseline, immediately after the intervention and 3-months after the intervention
Other outcomes:
Locations:
city: Makeni
country: Sierra Leone
facility: University of Makeni
Study officials:
affiliation: Boston College
name: Alethea Desrosiers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desrosiers A, Schafer C, Esliker R, Jambai M, Betancourt T. mHealth-Supported Delivery of an Evidence-Based Family Home-Visiting Intervention in Sierra Leone: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 2;10(2):e25443. doi: 10.2196/25443.