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

Child Development Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481399
• Other study ID #: 21.006.01
• Secondary ID: R21MH124071
• Status: Completed
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: August 16, 2023

Study information

• Verified date: November 2023
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 16, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Sierra Leone	University of Makeni	Makeni

Sponsors (3)

Lead Sponsor	Collaborator
Boston College	Caritas Freetown, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale	Feasibility of mHealth tool implementation to support FSI-ECD delivery will be assessed via a Dissemination and Implementation measures developed by the John Hopkins Bloomberg School of Health. This is a 20-item self-report measure and items are scored on a 4-point Likert scale: 1=not at all, 2=a little bit, 3=a moderate amount, 4=a lot.	Immediately after the intervention
Primary	Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale	Acceptability of mHealth tool implementation to support FSI-ECD delivery will be assessed via a Dissemination and Implementation measures developed by the John Hopkins Bloomberg School of Health. This is a 10-item self-report measure and items are scored on a 4-point Likert scale: 1=not at all, 2=a little bit, 3=a moderate amount, 4=a lot.	Immediately after the intervention
Secondary	Difficulties in Emotion Regulation Scale (DERS)	The Difficulties in Emotion Regulation Scale (DERS) is a 36-item measure that assesses emotion dysregulation across 6 domains, i.e., non-acceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. The DERS is scored on a 5-point Likert scale: 1=Almost Never, 2=Sometimes, 3=About half the time, 4=Most of the time, 5=Almost always. Higher scores indicate greater difficulties in emotion regulation.	Baseline, immediately after the intervention, and 3-months after the intervention
Secondary	Conflict Tactics Scale-2 (CTS-2)	The Conflict Tactics Scale (CTS-2) is a 78-item scale (39 behaviors or experiences, each asked once for respondent and one for partner). The CTS is comprised of 5 subscales, i.e., negotiation, psychological aggression, physical assault, injury, and sexual coercion. The response categories gauge the frequency with which acts were used during conflict with a partner in the past year using a 6-point scale ranging from "never" to "20 or more times." There are also response options of "Never in the last year, but it did happen before that," and "This has never happened."	Baseline, immediately after the intervention, and 3-months after the intervention
Secondary	Home Observation for Measurement of the Environment (HOME)	The Home Observation for Measurement of the Environment (HOME) is a 43-item measure that assesses the level of stimulation and support provided by caregivers in the home. All items receive a binary score based on the presence (score = 1) or absence (score = 0) of self-reported and direct observation of parenting behaviors and household conditions. Item scores are summed to derive scores on a total scale and the 6 subscales, i.e., variety, organization, acceptance, involvement, learning materials, and responsivity.	Baseline, immediately after the intervention, and 3-months after the intervention
Secondary	Observation of Mother-Child Interaction (OMCI)	The Observation of Mother-Child Interaction (OMCI) is a direct observational measure used to assess mother-child interaction during a shared picture-book reading activity that includes maternal (10 items) and child assessments (5 items). Maternal responsive behaviors include contingent responding, emotional-affective support, support for infant foci of attention, and language inputs. Child behaviors include the child's behavioral and social-emotional reactions during the observation. Each item is rated on a 4-point scale: 0 = Never, 1 = Very few, 2 = Sometimes (3-4 times), and 3 = Five or more times. Total scores are assigned for the mother's reaction, the child's reaction, and mother-child interaction, respectively.	Baseline, immediately after the intervention, and 3-months after the intervention
Secondary	Hopkins Symptom Checklist (HSCL)	The Hopkins Symptom Checklist (HSCL) is a 25-item inventory that measures symptoms of anxiety and depression. Part I of the measure has 10 items assessing anxiety symptoms and Part II has 15 items assessing depression symptoms. Each item is rated on a 4-point scale: 1 = Not at all, 2 = A little, 3 = Quite a bit, and 4 = Extremely. Item scores are summed to derive scores for the total scale and subscales, i.e., anxiety and depression.	Baseline, immediately after the intervention and 3-months after the intervention
Secondary	Post-traumatic Stress Disorder Civilian Checklist	The Post-traumatic Stress Disorder Civilian Checklist is a 17-item scale that assesses symptoms of Post-traumatic Stress Disorder. Items are rated on a binary scale of "yes" or "no" responses.	Baseline, immediately after the intervention and 3-months after the intervention