Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention
NCT04481399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2023-11-18
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.
Conditions
- Parent-Child Relations
- Behavioral Intervention
- Exposure to Violent Event
- Child Development
- Mental Health
- Implementation Science
- mHealth
- Community Health Workers
Interventions
- BEHAVIORAL
-
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.
- OTHER
-
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.
Sponsors & Collaborators
-
Caritas Freetown
collaborator OTHER -
National Institute of Mental Health (NIMH)
collaborator NIH -
Boston College
lead OTHER
Principal Investigators
-
Alethea Desrosiers, PhD · Boston College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-05
- Primary Completion
- 2023-02-01
- Completion
- 2023-08-16
Countries
- Sierra Leone
Study Locations
More Related Trials
-
Using mHealth to Improve Emotional Recovery After Pediatric Injury
NCT04579198 ·Status: COMPLETED ·Phase: NA
-
How Can Child Health Services Identify and Respond to Family Violence
NCT06299501 ·Status: COMPLETED ·Phase: NA
-
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
NCT05627206 ·Status: COMPLETED ·Phase: NA
-
Addressing Mental Health Disparities in Refugee Children
NCT03796065 ·Status: COMPLETED ·Phase: NA
-
Family Intervention to Improve Maternal and Child Mental Health
NCT04700059 ·Status: UNKNOWN ·Phase: NA
-
Mobilizing Community Networks to Optimize Child Well-being
NCT02622399 ·Status: COMPLETED ·Phase: NA
-
Improving the Mental Health of Home Health Aides
NCT06071221 ·Status: RECRUITING ·Phase: NA
-
The Effect of Nonviolent Resistance in Parent Group Training in Child Psychiatric Care
NCT05086328 ·Status: UNKNOWN
-
Evaluation of a Group-based, Skills Training for Increasing Mental Toughness
NCT07050238 ·Status: RECRUITING ·Phase: NA
-
Parent-Child Memory Study: Improving Future Thinking Among Mothers
NCT06145919 ·Status: RECRUITING ·Phase: NA
-
Prevention of Violent Behavior Among Children
NCT00056940 ·Status: COMPLETED ·Phase: NA
-
Pediatricians Building Resilience Through Early Identification for Toddler Well-Being
NCT07091240 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Evaluation of a Child Health Care Program for Early Identification of Family Violence
NCT07158983 ·Status: NOT_YET_RECRUITING
-
Improving Child Mental Health Service Utilization in Ibadan
NCT04627792 ·Status: UNKNOWN ·Phase: NA
-
Improving Behavioral Health for Caregivers and Children After Pediatric Injury
NCT06856057 ·Status: RECRUITING ·Phase: NA
-
Firearm Storage Device Distribution to Families of Children With Mental Health Complaints
NCT03386409 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment
NCT00586677 ·Status: COMPLETED ·Phase: NA
-
Preventing Youth Suicide in Primary Care: A Family Model
NCT00604097 ·Status: COMPLETED ·Phase: PHASE3
-
Assisting Low-Income Families at Pediatric Well-Child Care Visits
NCT00397644 ·Status: COMPLETED ·Phase: NA
-
Parents Advancing Toddler Health
NCT04824989 ·Status: UNKNOWN ·Phase: NA
-
Preventing Mental Health Problems After Childhood Severe Malaria
NCT03432039 ·Status: COMPLETED ·Phase: NA
-
Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention
NCT06350383 ·Status: COMPLETED ·Phase: NA
-
A Pilot Intervention With Families of Children With Special Health Care Needs
NCT02742831 ·Status: WITHDRAWN ·Phase: NA
-
Mental Health Care Coordination for Transition Aged Youth
NCT03336892 ·Status: COMPLETED ·Phase: NA
-
Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)
NCT05477901 ·Status: RECRUITING ·Phase: NA