<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/NCT03260725</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-13-0451-CR01</org_study_id>
    <nct_id>NCT03260725</nct_id>
  </id_info>
  <brief_title>Evaluating the Feasibility of Internet-delivered PCIT</brief_title>
  <official_title>Evaluating the Feasibility of Internet-delivered Parent-Child Interaction Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston University</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>
      The present study is leveraging a randomized-controlled design to evaluate an Internet-based&#xD;
      format for the delivery of Parent-Child Interaction Therapy (I-PCIT). Drawing on&#xD;
      videoteleconferencing technology, this format affords real-time interactions for the&#xD;
      provision of care traditionally delivered in person, regardless of a family's geographic&#xD;
      proximity to a mental health facility. Moreover, drawing on technological innovation to&#xD;
      deliver interventions directly to families in their natural settings may extend the&#xD;
      ecological validity of PCIT, as treatment is delivered in the very context in which child&#xD;
      problems occur. Families seeking treatment for early child disruptive behavior problems&#xD;
      (N=40) are being randomly assigned to either receive Internet-delivered PCIT or clinic-based&#xD;
      PCIT. Outcomes and feasibility/acceptability will be assessed across the treatment phase as&#xD;
      well as at post-treatment and 6-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Establishing the feasibility of an Internet-based format for the delivery of evidence-based&#xD;
      parent management is a critical step in the evaluation of technological innovations and their&#xD;
      potential for advancing children's mental health care. Drawing on teleconferencing&#xD;
      technology, such a format affords real-time interactions for the provision of care&#xD;
      traditionally delivered in person, regardless of a family's geographic proximity to a mental&#xD;
      health facility. Moreover, drawing on technological innovation to deliver interventions&#xD;
      directly to families in their natural settings may extend the ecological validity of&#xD;
      treatments, as treatments are delivered in the very contexts in which child problems occur.&#xD;
&#xD;
      The objective of the present study is to develop an Internet-delivered Parent-Child&#xD;
      Interaction Therapy (PCIT) protocol for preschoolers with Oppositional Defiant Disorder (ODD)&#xD;
      or Conduct Disorder (CD) and to evaluate via randomized controlled trial (RCT) the&#xD;
      feasibility and acceptability of enrolling, retaining, and treating children with I-PCIT&#xD;
      relative to traditional PCIT. Phase I will involve development of an Internet-delivered PCIT&#xD;
      (I-PCIT) protocol and treatment materials, including therapist treatment manual and online&#xD;
      session handouts. Phase II will entail a case series: the PI will treat 5 consecutive&#xD;
      preschool ODD/CD cases with I-PCIT, affording opportunity to further work out any&#xD;
      difficulties with protocol or equipment. Phase III will entail testing the feasibility and&#xD;
      acceptability of I-PCIT in a pilot RCT conducted with 40 children (ages 3-5) meeting for a&#xD;
      Diagnostic and Statistical Manual (DSM-IV) principal diagnosis of ODD or CD and their&#xD;
      parent(s) randomly assigned to I-PCIT or traditional PCIT. Parents will provide informed&#xD;
      consent. All eligible families will receive evidence based treatment. Treatment will either&#xD;
      be either in-clinic Parent-Child Interaction Therapy (PCIT) or Internet-delivered PCIT&#xD;
      (I-PCIT). Formal evaluations will be conducted at baseline, post-treatment, and 6-month&#xD;
      follow-up. Families can opt to participate in two optional psychophysiological components of&#xD;
      the study (one involving behavioral tasks while parents are monitored via physiological&#xD;
      equipment, and one involving play tasks while children are monitored via physiological&#xD;
      equipment). All assessments will be conducted in the Department of Psychology at Florida&#xD;
      International University (FIU), in the Center for Children and Families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2011</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>
    <intervention_model_description>Internet-delivered treatment v. clinic-delivered treatment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Global Impressions (CGI) Improvement Scale</measure>
    <time_frame>Post-treatment (average = 35.2 weeks)</time_frame>
    <description>Most widely used clinician-rated measure of treatment-related changes in functioning. The CGI-Improvement rates improvement on a 7-point scale, ranging from 1 (&quot;very much improved&quot;) to 7 (&quot;very much worse&quot;). CGI-Improvement scores of 1 (&quot;very much improved&quot;) or 2 (&quot;much improved&quot;) reflect &quot;treatment response.&quot; CGI-Improvement scores of 1 (&quot;very much improved&quot;) reflect &quot;excellent response.&quot; Completed by Independent Evaluator (IE) in present study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eyberg Child Behavior Inventory (ECBI)</measure>
    <time_frame>Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up</time_frame>
    <description>Parent-report of child behavior problems that yields an Intensity Score (indicating frequency of symptoms, scores over 132 reflect clinical range) and Problem Score (indicating how problematic symptoms are for caregivers).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)</measure>
    <time_frame>Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up</time_frame>
    <description>A supported parent interview that covers ODD, CD, and Attention-Deficit/Hyperactivity Disorder (ADHD), in preschoolers.&#xD;
Items are worded to maximize DSM-IV consistency, while retaining developmental appropriateness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers to Treatment Participation Scale (BTPS)</measure>
    <time_frame>Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks)</time_frame>
    <description>44-item parent-report measure of perceived barriers to treatment participation. Items are rated along 5-point scales and assess stressors and obstacles that compete with treatment (e.g., transportation, scheduling), treatment demands issues (e.g., uncomfortable treatment setting), and attitudes about treatment and the therapist (e.g., treatment is not working). Tallying the items yields a total barriers score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Global Assessment Scale (CGAS)</measure>
    <time_frame>Baseline, post-treatment (average = 35.2 weeks), and 6 month follow-up</time_frame>
    <description>Clinician-rated index of functioning. Scores range from 0-100; lower scores indicate greater impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>Post-treatment (average = 35.2 weeks)</time_frame>
    <description>Assessment of consumer satisfaction with services. Used as a parent report in present study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapy Attitude Inventory (TAI)</measure>
    <time_frame>Posttreatment (average = 35.2 weeks)</time_frame>
    <description>Parent-report of satisfaction with parent training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Behavior Checklist for ages 1.5 to 5 (CBCL 1.5-5)</measure>
    <time_frame>Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up</time_frame>
    <description>Standardized instrument for assessing behavioral and emotional problems in young children, demonstrating very strong psychometric properties. Empirically based scales, normed for age and sex, are generated. T-scores below 65 reflect normative functioning.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Oppositional Defiant Disorder</condition>
  <condition>Conduct Disorder</condition>
  <condition>Disruptive Behavior Disorder Nos</condition>
  <arm_group>
    <arm_group_label>Internet-delivered treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This treatment arm entails Internet-Delivered PCIT (I-PCIT) remotely delivered in real time using videoconferencing. Families stream live parent-child interactions from their own home to a remote therapist who provides live bug-in-the-ear parent coaching via a parent-worn Bluetooth earpiece.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic-delivered treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This treatment arm entails Parent-Child Interaction Therapy (PCIT) delivered in the clinic. For much of the treatment, the therapist observes family interactions from behind a 1-way mirror and provides live bug-in-the-ear parent coaching via a parent-worn earpiece.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent-Child Interaction Therapy (PCIT)</intervention_name>
    <description>PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered in the clinic.</description>
    <arm_group_label>Clinic-delivered treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-delivered PCIT (I-PCIT)</intervention_name>
    <description>I-PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered to families in their own home in real-time via videoconferencing over the Internet by a remote therapist.</description>
    <arm_group_label>Internet-delivered treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children (ages 3-5) meeting for DSM-IV principal Oppositional Defiant Disorder (ODD)&#xD;
             or Conduct Disorder (CD), and at least 1 primary caretaker.&#xD;
&#xD;
          -  Eyberg Child Behavior Inventory-Intensity Score in clinical range (i.e., &gt;132).&#xD;
&#xD;
          -  English-speaking (child &amp; caretakers).&#xD;
&#xD;
          -  Family home equipped w/ broadband connection and computer equipped with Pentium (or&#xD;
             compatible) processor, 128 MB random-access memory (RAM), 200 Megabytes available of&#xD;
             hard disk space, 16-bit color display adapter, universal series bus (USB) port.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Behavior problems due to organic pathology or trauma,&#xD;
&#xD;
          -  Child receiving medication to manage behavior difficulties,&#xD;
&#xD;
          -  Presence of child emotional/behavior problem more impairing than ODD or CD,&#xD;
&#xD;
          -  Parent or child score &lt;75 standard score on intelligence quotient (IQ) screening,&#xD;
&#xD;
          -  History of severe physical or mental impairments (e.g., mental retardation, deafness,&#xD;
             blindness, pervasive developmental disorder) in child or participating caretaker(s).&#xD;
&#xD;
          -  Child is a ward of the state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Florida International University</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
    <mesh_term>Conduct Disorder</mesh_term>
    <mesh_term>Attention Deficit and Disruptive Behavior Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The investigators will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.</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/NCT03260725
org study id: IRB-13-0451-CR01
nct id: NCT03260725
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study is leveraging a randomized-controlled design to evaluate an Internet-based
      format for the delivery of Parent-Child Interaction Therapy (I-PCIT). Drawing on
      videoteleconferencing technology, this format affords real-time interactions for the
      provision of care traditionally delivered in person, regardless of a family's geographic
      proximity to a mental health facility. Moreover, drawing on technological innovation to
      deliver interventions directly to families in their natural settings may extend the
      ecological validity of PCIT, as treatment is delivered in the very context in which child
      problems occur. Families seeking treatment for early child disruptive behavior problems
      (N=40) are being randomly assigned to either receive Internet-delivered PCIT or clinic-based
      PCIT. Outcomes and feasibility/acceptability will be assessed across the treatment phase as
      well as at post-treatment and 6-month follow-up.
Establishing the feasibility of an Internet-based format for the delivery of evidence-based
      parent management is a critical step in the evaluation of technological innovations and their
      potential for advancing children's mental health care. Drawing on teleconferencing
      technology, such a format affords real-time interactions for the provision of care
      traditionally delivered in person, regardless of a family's geographic proximity to a mental
      health facility. Moreover, drawing on technological innovation to deliver interventions
      directly to families in their natural settings may extend the ecological validity of
      treatments, as treatments are delivered in the very contexts in which child problems occur.

      The objective of the present study is to develop an Internet-delivered Parent-Child
      Interaction Therapy (PCIT) protocol for preschoolers with Oppositional Defiant Disorder (ODD)
      or Conduct Disorder (CD) and to evaluate via randomized controlled trial (RCT) the
      feasibility and acceptability of enrolling, retaining, and treating children with I-PCIT
      relative to traditional PCIT. Phase I will involve development of an Internet-delivered PCIT
      (I-PCIT) protocol and treatment materials, including therapist treatment manual and online
      session handouts. Phase II will entail a case series: the PI will treat 5 consecutive
      preschool ODD/CD cases with I-PCIT, affording opportunity to further work out any
      difficulties with protocol or equipment. Phase III will entail testing the feasibility and
      acceptability of I-PCIT in a pilot RCT conducted with 40 children (ages 3-5) meeting for a
      Diagnostic and Statistical Manual (DSM-IV) principal diagnosis of ODD or CD and their
      parent(s) randomly assigned to I-PCIT or traditional PCIT. Parents will provide informed
      consent. All eligible families will receive evidence based treatment. Treatment will either
      be either in-clinic Parent-Child Interaction Therapy (PCIT) or Internet-delivered PCIT
      (I-PCIT). Formal evaluations will be conducted at baseline, post-treatment, and 6-month
      follow-up. Families can opt to participate in two optional psychophysiological components of
      the study (one involving behavioral tasks while parents are monitored via physiological
      equipment, and one involving play tasks while children are monitored via physiological
      equipment). All assessments will be conducted in the Department of Psychology at Florida
      International University (FIU), in the Center for Children and Families.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Internet-delivered treatment v. clinic-delivered treatment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical Global Impressions (CGI) Improvement Scale
time frame: Post-treatment (average = 35.2 weeks)
description: Most widely used clinician-rated measure of treatment-related changes in functioning. The CGI-Improvement rates improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse"). CGI-Improvement scores of 1 ("very much improved") or 2 ("much improved") reflect "treatment response." CGI-Improvement scores of 1 ("very much improved") reflect "excellent response." Completed by Independent Evaluator (IE) in present study.
measure: Eyberg Child Behavior Inventory (ECBI)
time frame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
description: Parent-report of child behavior problems that yields an Intensity Score (indicating frequency of symptoms, scores over 132 reflect clinical range) and Problem Score (indicating how problematic symptoms are for caregivers).
measure: Kiddie Disruptive Behavior Disorders Schedule (K-DBDS)
time frame: Baseline, post treatment (average = 35.2 weeks), and 6 month follow-up
description: A supported parent interview that covers ODD, CD, and Attention-Deficit/Hyperactivity Disorder (ADHD), in preschoolers.
Items are worded to maximize DSM-IV consistency, while retaining developmental appropriateness.
measure: Barriers to Treatment Participation Scale (BTPS)
time frame: Mid-treatment (average = 17.2 weeks) and post treatment (average = 35.2 weeks)
description: 44-item parent-report measure of perceived barriers to treatment participation. Items are rated along 5-point scales and assess stressors and obstacles that compete with treatment (e.g., transportation, scheduling), treatment demands issues (e.g., uncomfortable treatment setting), and attitudes about treatment and the therapist (e.g., treatment is not working). Tallying the items yields a total barriers score
measure: Children's Global Assessment Scale (CGAS)
time frame: Baseline, post-treatment (average = 35.2 weeks), and 6 month follow-up
description: Clinician-rated index of functioning. Scores range from 0-100; lower scores indicate greater impairment.
measure: Client Satisfaction Questionnaire (CSQ-8)
time frame: Post-treatment (average = 35.2 weeks)
description: Assessment of consumer satisfaction with services. Used as a parent report in present study
measure: Therapy Attitude Inventory (TAI)
time frame: Posttreatment (average = 35.2 weeks)
description: Parent-report of satisfaction with parent training
measure: Child Behavior Checklist for ages 1.5 to 5 (CBCL 1.5-5)
time frame: Baseline, mid-treatment (average = 17.2 weeks), post treatment (average = 35.2 weeks), and 6 month follow-up
description: Standardized instrument for assessing behavioral and emotional problems in young children, demonstrating very strong psychometric properties. Empirically based scales, normed for age and sex, are generated. T-scores below 65 reflect normative functioning.
arm group label: Internet-delivered treatment
arm group type: Experimental
description: This treatment arm entails Internet-Delivered PCIT (I-PCIT) remotely delivered in real time using videoconferencing. Families stream live parent-child interactions from their own home to a remote therapist who provides live bug-in-the-ear parent coaching via a parent-worn Bluetooth earpiece.
arm group label: Clinic-delivered treatment
arm group type: Active Comparator
description: This treatment arm entails Parent-Child Interaction Therapy (PCIT) delivered in the clinic. For much of the treatment, the therapist observes family interactions from behind a 1-way mirror and provides live bug-in-the-ear parent coaching via a parent-worn earpiece.
intervention type: Behavioral
intervention name: Parent-Child Interaction Therapy (PCIT)
description: PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered in the clinic.
arm group label: Clinic-delivered treatment
intervention type: Behavioral
intervention name: Internet-delivered PCIT (I-PCIT)
description: I-PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered to families in their own home in real-time via videoconferencing over the Internet by a remote therapist.
arm group label: Internet-delivered treatment
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Problem Behavior
mesh term: Conduct Disorder
mesh term: Attention Deficit and Disruptive Behavior Disorders
sharing ipd: Undecided
ipd description: The investigators will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.