<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/NCT04459845</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-17-0265-CR02</org_study_id>
    <nct_id>NCT04459845</nct_id>
  </id_info>
  <brief_title>Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs</brief_title>
  <official_title>Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lotus House</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida International University</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>
      This study aims to compare the efficacy in delivering two evidence-based parenting programs&#xD;
      to families and young children experiencing homelessness. Outcomes evaluated include&#xD;
      feasibility, treatment completion, treatment satisfaction of delivery of interventions as&#xD;
      well as child outcomes (e.g., behavior problems, trauma symptoms) and parenting outcomes&#xD;
      (parenting stress and parenting skills).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of homeless families in the U.S. has increased since the 1980s to over half a&#xD;
      million as of 2018. Most troubling, in 2013 (the most recent year for which census data is&#xD;
      available) one in every 30 children in the U.S., or 2.5 million, experienced homelessness. In&#xD;
      addition to having disproportionally higher rates of unmet health needs (e.g., acute health&#xD;
      problems, trauma-related injuries), children experiencing homelessness have staggering mental&#xD;
      health needs such that 78% suffer from at least one mental health issue (e.g., depression,&#xD;
      behavior problems) along with academic/developmental delays. Given that over half of all&#xD;
      homeless children in the US are under the age of 6, it is particularly important to&#xD;
      investigate the effectiveness of evidence-based parenting programs within a homeless&#xD;
      population. This study aims to compare the efficacy in delivering two evidence-based&#xD;
      parenting programs to families and young children experiencing homelessness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator and outcomes assessor are masked to the treatment group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Eyberg Child Behavior Inventory (ECBI)</measure>
    <time_frame>16 weeks after start of intervention</time_frame>
    <description>Change in overall externalizing behavior problems</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child and Adolescent Trauma Screener (CATS)</measure>
    <time_frame>16 weeks after start of intervention</time_frame>
    <description>Change in overall PTSD symptom severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting Stress Index Short Form 4th edition (PSI-SF)</measure>
    <time_frame>16 weeks after start of intervention</time_frame>
    <description>Change in overall level of parenting stress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Dyadic Parent-Child Interaction Coding System</measure>
    <time_frame>16 weeks after start of intervention</time_frame>
    <description>Change in positive and negative parenting skills observed during 5 minute child led play session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Therapy Attitude Inventory</measure>
    <time_frame>16 weeks after start of intervention</time_frame>
    <description>Mothers' satisfaction with treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Attendance</measure>
    <time_frame>16 weeks after start of intervention</time_frame>
    <description>Percentage of families who completed the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Behavior Problem</condition>
  <condition>Parenting</condition>
  <arm_group>
    <arm_group_label>Parent Child Interaction Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents and children will receive 12 weekly sessions of PCIT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child Parent Psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents and children will receive 12 weekly sessions of CPP</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent Child Interaction Therapy</intervention_name>
    <description>Parent-child Interaction therapy (PCIT; Eyberg and Robinson, 1982) s a manualized evidence-based behavioral parent training program that integrates social learning and attachment theories. Parents proceed through two distinct phases: Child-Directed Interaction (CDI) resembles traditional play therapy, and Parent-Directed Interaction (PDI) resembles clinical behavior therapy. During all sessions, the therapist coaches each parent in vivo in their use of the CDI and PDI skills with their child.</description>
    <arm_group_label>Parent Child Interaction Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child Parent Psychotherapy</intervention_name>
    <description>Child-parent psychotherapy (CPP; Lieberman et al., 2005) is a relationship-based treatment that integrates attachment, cognitive-behavioral, social-learning, and psychodynamic theories. CPP focuses on the child-parent relationship as a way to improve the child's adaptive functioning. Various treatment strategies are employed including a focus on safety, affect regulation, the joint construction of a trauma narrative, and engagement in developmentally appropriate activities.</description>
    <arm_group_label>Child Parent Psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any child between the ages of 2 and 5 and his/her mother who is currently homeless and&#xD;
             living in the Lotus House shelter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family is already involved in a parenting program or does not speak English or&#xD;
             Spanish.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paulo Graziano, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida International University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lotus House</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida International University</investigator_affiliation>
    <investigator_full_name>Paulo A. Graziano, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>early intervention</keyword>
  <keyword>parenting</keyword>
  <keyword>homelessness</keyword>
  <keyword>parent child interaction therapy</keyword>
  <keyword>child parent psychotherapy</keyword>
  <keyword>behavior problems</keyword>
  <keyword>trauma symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified summary data from the study will be shared with other researchers upon request and after completion of study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Upon completion of study and for 3 years.</ipd_time_frame>
  </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/NCT04459845
org study id: IRB-17-0265-CR02
nct id: NCT04459845
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare the efficacy in delivering two evidence-based parenting programs
      to families and young children experiencing homelessness. Outcomes evaluated include
      feasibility, treatment completion, treatment satisfaction of delivery of interventions as
      well as child outcomes (e.g., behavior problems, trauma symptoms) and parenting outcomes
      (parenting stress and parenting skills).
The number of homeless families in the U.S. has increased since the 1980s to over half a
      million as of 2018. Most troubling, in 2013 (the most recent year for which census data is
      available) one in every 30 children in the U.S., or 2.5 million, experienced homelessness. In
      addition to having disproportionally higher rates of unmet health needs (e.g., acute health
      problems, trauma-related injuries), children experiencing homelessness have staggering mental
      health needs such that 78% suffer from at least one mental health issue (e.g., depression,
      behavior problems) along with academic/developmental delays. Given that over half of all
      homeless children in the US are under the age of 6, it is particularly important to
      investigate the effectiveness of evidence-based parenting programs within a homeless
      population. This study aims to compare the efficacy in delivering two evidence-based
      parenting programs to families and young children experiencing homelessness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigator and outcomes assessor are masked to the treatment group
measure: Eyberg Child Behavior Inventory (ECBI)
time frame: 16 weeks after start of intervention
description: Change in overall externalizing behavior problems
measure: Child and Adolescent Trauma Screener (CATS)
time frame: 16 weeks after start of intervention
description: Change in overall PTSD symptom severity
measure: Parenting Stress Index Short Form 4th edition (PSI-SF)
time frame: 16 weeks after start of intervention
description: Change in overall level of parenting stress
measure: The Dyadic Parent-Child Interaction Coding System
time frame: 16 weeks after start of intervention
description: Change in positive and negative parenting skills observed during 5 minute child led play session
measure: Therapy Attitude Inventory
time frame: 16 weeks after start of intervention
description: Mothers' satisfaction with treatment
measure: Treatment Attendance
time frame: 16 weeks after start of intervention
description: Percentage of families who completed the intervention
arm group label: Parent Child Interaction Therapy
arm group type: Active Comparator
description: Parents and children will receive 12 weekly sessions of PCIT.
arm group label: Child Parent Psychotherapy
arm group type: Active Comparator
description: Parents and children will receive 12 weekly sessions of CPP
intervention type: Behavioral
intervention name: Parent Child Interaction Therapy
description: Parent-child Interaction therapy (PCIT; Eyberg and Robinson, 1982) s a manualized evidence-based behavioral parent training program that integrates social learning and attachment theories. Parents proceed through two distinct phases: Child-Directed Interaction (CDI) resembles traditional play therapy, and Parent-Directed Interaction (PDI) resembles clinical behavior therapy. During all sessions, the therapist coaches each parent in vivo in their use of the CDI and PDI skills with their child.
arm group label: Parent Child Interaction Therapy
intervention type: Behavioral
intervention name: Child Parent Psychotherapy
description: Child-parent psychotherapy (CPP; Lieberman et al., 2005) is a relationship-based treatment that integrates attachment, cognitive-behavioral, social-learning, and psychodynamic theories. CPP focuses on the child-parent relationship as a way to improve the child's adaptive functioning. Various treatment strategies are employed including a focus on safety, affect regulation, the joint construction of a trauma narrative, and engagement in developmentally appropriate activities.
arm group label: Child Parent Psychotherapy
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paulo Graziano, Ph.D
role: Principal Investigator
affiliation: Florida International University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida International University
investigator full name: Paulo A. Graziano, PhD
investigator title: Associate Professor
mesh term: Problem Behavior
sharing ipd: Yes
ipd description: De-identified summary data from the study will be shared with other researchers upon request and after completion of study.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Upon completion of study and for 3 years.