<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481399</url>
  </required_header>
  <id_info>
    <org_study_id>21.006.01</org_study_id>
    <nct_id>NCT04481399</nct_id>
  </id_info>
  <brief_title>Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Caritas Freetown</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed exploratory research will pilot a family-focused, behavioral health intervention&#xD;
      while also developing and piloting innovative and cost-effective mHealth tools to support&#xD;
      Community Health Workers (CHWs) in Sierra Leone. This dual focus will help build capacity&#xD;
      both for delivery of evidence-based mental health services to reduce family violence and&#xD;
      harsh parenting practices, and for effective use of mHealth strategies to improve healthcare&#xD;
      delivery and quality. This study will leverage Government of Sierra Leone investments in&#xD;
      community health initiatives and mHealth innovations as a strategy to address critical&#xD;
      healthcare workforce limitations that plague delivery of evidence-based interventions to&#xD;
      vulnerable families in post-conflict Sierra Leone. The study will pilot mHealth-supported&#xD;
      delivery of a culturally adapted version of the Family Strengthening Intervention for Early&#xD;
      Childhood Development (FSI-ECD). The FSI-ECD has demonstrated effectiveness in improving&#xD;
      parental emotion regulation and reducing family violence and harsh parenting practices among&#xD;
      high-risk families with children aged 6-36 months in Rwanda. Study aims are to:&#xD;
&#xD;
      Aim 1. Employ a five-phase user-centered design approach to develop and test mHealth tools to&#xD;
      improve training, supervision, and fidelity monitoring of Community Health Workers. Study&#xD;
      investigators hypothesize that mHealth tools will be feasible, acceptable, and user-friendly.&#xD;
&#xD;
      Aim 2. Conduct a Randomized Controlled Pilot Study to assess feasibility, acceptability, and&#xD;
      preliminary effects of the mHealth-supported delivery of FSI-ECD on parent mental health,&#xD;
      emotion regulation, and familial violence in high risk families with children aged 6-36&#xD;
      months (n=40) in comparison to control families (n=40) who receive standard care. Parental&#xD;
      mental health, emotion regulation, household violence, and parenting practices will be&#xD;
      assessed at baseline, post-intervention and 6-month follow-up. The pilot study will also&#xD;
      integrate a cost-effectiveness analysis to assess the economic value of the mHealth-supported&#xD;
      delivery of the FSI-ECD vs. standard care. Study investigators hypothesize that (a) the&#xD;
      effects of the FSI-ECD will be comparable to results observed with vulnerable families in&#xD;
      Rwanda; (b) digital tools will be feasible and acceptable to CHWs and supervisors; and (c)&#xD;
      mHealth-enhanced supervision and fidelity monitoring will increase supervisor engagement and&#xD;
      support CHW quality improvement cycles.&#xD;
&#xD;
      Aim 3. Leverage well-established relationships and government partners to strengthen capacity&#xD;
      for mHealth research and quality healthcare delivery in Sierra Leone. Partners include the&#xD;
      University of Makeni, the Directorate of Science, Technology and Innovation, and the Ministry&#xD;
      of Health and Sanitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 5, 2021</start_date>
  <completion_date type="Anticipated">February 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS)</measure>
    <time_frame>Baseline, immediately after the intervention, and 3-months after the intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conflict Tactics Scale-2 (CTS-2)</measure>
    <time_frame>Baseline, immediately after the intervention, and 3-months after the intervention</time_frame>
    <description>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 &quot;never&quot; to &quot;20 or more times.&quot; There are also response options of &quot;Never in the last year, but it did happen before that,&quot; and &quot;This has never happened.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home Observation for Measurement of the Environment (HOME)</measure>
    <time_frame>Baseline, immediately after the intervention, and 3-months after the intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observation of Mother-Child Interaction (OMCI)</measure>
    <time_frame>Baseline, immediately after the intervention, and 3-months after the intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hopkins Symptom Checklist (HSCL)</measure>
    <time_frame>Baseline, immediately after the intervention and 3-months after the intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-traumatic Stress Disorder Civilian Checklist</measure>
    <time_frame>Baseline, immediately after the intervention and 3-months after the intervention</time_frame>
    <description>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 &quot;yes&quot; or &quot;no&quot; responses.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Parent-Child Relations</condition>
  <condition>Behavioral Intervention</condition>
  <condition>Exposure to Violent Event</condition>
  <condition>Child Development</condition>
  <condition>Mental Health</condition>
  <condition>Implementation Science</condition>
  <condition>mHealth</condition>
  <condition>Community Health Workers</condition>
  <arm_group>
    <arm_group_label>FSI-ECD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Strengthening Intervention for Early Childhood Development</intervention_name>
    <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. 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.</description>
    <arm_group_label>FSI-ECD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community Health Worker Routine</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Focus Group-User Interface/User Experience (UI/UX) Participants: Aged 18 or older;&#xD;
             ability to attend 1-2 sessions (90 minutes per session)&#xD;
&#xD;
          -  Family Participants: Families who are (a) a Sierra Leonean household with cohabitating&#xD;
             caregivers (e.g., father/mother, mother/grandmother, mother/intimate partner), and&#xD;
             child (aged 6-36 months) with both parents aged 18 or older and; (b) one parent&#xD;
             scoring at least 62.5 on the Difficulties in Emotion Regulation Scale (DERS). The DERS&#xD;
             cut-off score has been used successfully as a risk assessment screening tool in our&#xD;
             prior and ongoing studies in Sierra Leone. Sierra Leonean caregivers scoring above&#xD;
             this threshold on the DERS have reported significantly higher levels of severe&#xD;
             physical punishment with their children as well as intimate partner violence. Both&#xD;
             parents must agree to attend FSI-ECD sessions. If enrolled families have more than one&#xD;
             child aged 6-36 months, we will include all eligible children as study participants.&#xD;
&#xD;
          -  Community Health Worker Participants: CHWs who are 18 years or older and who are&#xD;
             assigned to the Peripheral Health Unit that provides health services in one of our&#xD;
             target communities.&#xD;
&#xD;
          -  Community Health Worker Supervisor Participants: Supervisors are 18 years or older and&#xD;
             oversee CHWs providing maternal and child health services&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Focus Group-User Interface/User Experience (UI/UX) Participants: Individuals younger&#xD;
             than age 18 and individuals who do not meet inclusion criteria.&#xD;
&#xD;
          -  Family Participants: Families who do not meet all inclusion criteria and/or who are&#xD;
             experiencing active family crises (e.g., current suicidality or psychosis, cognitive&#xD;
             impairment, ongoing divorce process).&#xD;
&#xD;
          -  Community Health Worker Participants: Individuals under age 18 cannot be recruited to&#xD;
             work as a CHW.&#xD;
&#xD;
          -  Community Health Worker Supervisor Participants: Individuals under age 18.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alethea Desrosiers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Makeni</name>
      <address>
        <city>Makeni</city>
        <country>Sierra Leone</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sierra Leone</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston College</investigator_affiliation>
    <investigator_full_name>Alethea Desrosiers</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data sharing will be in accordance with the NIH Data Sharing Policy and Implementation Guidance and more specifically the &quot;Data Sharing Expectations for National Institute of Mental Health (NIMH)-funded Clinical Trials&quot;. The data generated in this study will be entered into the NIMH Data Archive as required and prescribed by the Notice of Award as well as presented at national and/or international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Published data will be available in print or electronically from publishers, subject to subscription or printing charges. Research data that document, support and validate research findings will be made available after the main findings from the final research data set have been accepted for publication.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481399
org study id: 21.006.01
nct id: NCT04481399
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed exploratory research will pilot a family-focused, behavioral health intervention
      while also developing and piloting innovative and cost-effective 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 and quality. This study will leverage Government of Sierra Leone investments in
      community health initiatives and mHealth innovations as a strategy to address critical
      healthcare workforce limitations that plague delivery of evidence-based interventions to
      vulnerable families in post-conflict Sierra Leone. The study will pilot mHealth-supported
      delivery of a culturally adapted version of the Family Strengthening Intervention for Early
      Childhood Development (FSI-ECD). The FSI-ECD has demonstrated effectiveness in improving
      parental emotion regulation and reducing family violence and harsh parenting practices among
      high-risk families with children aged 6-36 months in Rwanda. 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, 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. The pilot study will also
      integrate a cost-effectiveness analysis to assess the economic value of the mHealth-supported
      delivery of the FSI-ECD vs. standard care. 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; and (c)
      mHealth-enhanced supervision and fidelity monitoring will increase supervisor engagement and
      support CHW quality improvement cycles.

      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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale
time frame: Immediately after the intervention
description: 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.
measure: Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale
time frame: Immediately after the intervention
description: 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.
measure: Difficulties in Emotion Regulation Scale (DERS)
time frame: Baseline, immediately after the intervention, and 3-months after the intervention
description: 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.
measure: Conflict Tactics Scale-2 (CTS-2)
time frame: Baseline, immediately after the intervention, and 3-months after the intervention
description: 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."
measure: Home Observation for Measurement of the Environment (HOME)
time frame: Baseline, immediately after the intervention, and 3-months after the intervention
description: 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.
measure: Observation of Mother-Child Interaction (OMCI)
time frame: Baseline, immediately after the intervention, and 3-months after the intervention
description: 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.
measure: Hopkins Symptom Checklist (HSCL)
time frame: Baseline, immediately after the intervention and 3-months after the intervention
description: 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.
measure: Post-traumatic Stress Disorder Civilian Checklist
time frame: Baseline, immediately after the intervention and 3-months after the intervention
description: 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.
arm group label: FSI-ECD
arm group type: Experimental
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.
arm group label: Control
arm group type: Other
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.
intervention type: Behavioral
intervention name: Family Strengthening Intervention for Early Childhood Development
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. 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.
arm group label: FSI-ECD
intervention type: Other
intervention name: Community Health Worker Routine
description: 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.
arm group label: Control
criteria: 
gender: All
minimum age: 6 Months
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alethea Desrosiers, PhD
role: Principal Investigator
affiliation: Boston College
facility: 
country: Sierra Leone
responsible party type: Principal Investigator
investigator affiliation: Boston College
investigator full name: Alethea Desrosiers
investigator title: Research Assistant Professor
sharing ipd: Yes
ipd description: Data sharing will be in accordance with the NIH Data Sharing Policy and Implementation Guidance and more specifically the "Data Sharing Expectations for National Institute of Mental Health (NIMH)-funded Clinical Trials". The data generated in this study will be entered into the NIMH Data Archive as required and prescribed by the Notice of Award as well as presented at national and/or international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Published data will be available in print or electronically from publishers, subject to subscription or printing charges. Research data that document, support and validate research findings will be made available after the main findings from the final research data set have been accepted for publication.