<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/NCT02972086</url>
  </required_header>
  <id_info>
    <org_study_id>16-01291</org_study_id>
    <nct_id>NCT02972086</nct_id>
  </id_info>
  <brief_title>Improving Behavioral Health Care for Children With ADHD</brief_title>
  <official_title>Improving Behavioral Health Care for Children With ADHD: Integration of Family Peer Advocates to Deliver Behavioral Parent Training in Pediatric Care Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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 purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC)&#xD;
      Model. The IPFAC is intended to increase access to evidence-based behavioral parent training&#xD;
      (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD)&#xD;
      who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of&#xD;
      Developmental and Behavioral Pediatrics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of this study are to: 1) Develop the IPFAC model (Phase I); 2) Assess and&#xD;
      determine facilitators and barriers to fidelity, assess feasibility of data acquisition,&#xD;
      determine preliminary efficacy, and refine the IPFAC model through a small-scale&#xD;
      implementation study and Plan-Do-Study-Act methods (Phase II), and, 3) Evaluate the revised&#xD;
      IPFAC model in a small-scale study using state-of-the-art single-case study design&#xD;
      methods/analyses to test &quot;treatment mechanisms&quot; in a sample of newly diagnosed youth with&#xD;
      ADHD (Phase III) and finalize the IPFAC procedural manual.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2017</start_date>
  <completion_date type="Actual">August 7, 2017</completion_date>
  <primary_completion_date type="Actual">August 7, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attendance at BPT sessions</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Family Practice Associates (FPAs) will provide information on the extent to which the family attended scheduled BPT sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting Behavior</measure>
    <time_frame>16 Weeks</time_frame>
    <description>The Alabama Parenting Questionnaire- Short Form (APQ-SF) is a well-validated 9-item measure of parenting style. Items are rated by the parent scored based on frequency of parenting behavior from Never (1), Almost Never (2), Sometimes (3), Often (4), Always (5). APQ-SF items are based around the three main structures: positive parenting, inconsistent discipline and poor supervision.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADHD and oppositional behavior will be measured by the IOWA Connors Rating Scale (IOWA-CRS)</measure>
    <time_frame>16 Weeks</time_frame>
    <description>The IOWA-CRS (Waschbusch &amp; Willoughby, 2008) is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. The IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental Depressive Symptoms using Beck Depression Inventory-II</measure>
    <time_frame>16 Weeks</time_frame>
    <description>a 21-item self-report measure used to assess maternal depressive symptoms. Mothers were instructed to indicate which of four statements best described how they felt over the preceding two week period. The BDI is scored from one to four, with higher scores on the BDI indicating a greater degree of depression. A total score on the BDI, which is a sum of the 21-item measure, will be used in the study.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Parent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parent of a child who is a patient at the NYU Bellevue Attention Deficit Hyperactivity Disorder (ADHD) Clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Parent Training (BPT)</intervention_name>
    <description>A specific intervention modality that has been shown to improve key functional outcomes in youth with ADHD.</description>
    <arm_group_label>Parent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being a parent of a child who is a patient at the NYU Bellevue ADHD Clinic&#xD;
&#xD;
          -  being an adult over the age of 18&#xD;
&#xD;
          -  having a child who obtained a diagnosis of ADHD (any subtype) within the previous 3&#xD;
             months (ie.., newly diagnosed) through the NYU Bellevue ADHD Clinic&#xD;
&#xD;
          -  parent must speak English and/or Spanish.&#xD;
&#xD;
        The second study participant is the child. Study inclusion criteria for children include:&#xD;
&#xD;
          -  child is a patient at the NYU Bellevue ADHD Clinic&#xD;
&#xD;
          -  child is between the age of 6-11&#xD;
&#xD;
          -  participating child must have obtained a diagnosis of ADHD (any subtype) within the&#xD;
             previous 3 months (i.e., newly diagnosed) through the NYU Bellevue ADHD Clinic,&#xD;
&#xD;
          -  child must speak English and/or Spanish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parent presenting with severe mental health illness (e.g., schizophrenia; bipolar&#xD;
             disorder) that would warrant immediate services.&#xD;
&#xD;
          -  child with primary diagnosis/presenting issues of severe mental illness (e.g.,&#xD;
             schizophrenia; bipolar disorder) that would warrant primary services other than what&#xD;
             is offered through the project.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Hopkins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Pediatric Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02972086
org study id: 16-01291
nct id: NCT02972086
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC)
      Model. The IPFAC is intended to increase access to evidence-based behavioral parent training
      (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD)
      who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of
      Developmental and Behavioral Pediatrics.
The specific aims of this study are to: 1) Develop the IPFAC model (Phase I); 2) Assess and
      determine facilitators and barriers to fidelity, assess feasibility of data acquisition,
      determine preliminary efficacy, and refine the IPFAC model through a small-scale
      implementation study and Plan-Do-Study-Act methods (Phase II), and, 3) Evaluate the revised
      IPFAC model in a small-scale study using state-of-the-art single-case study design
      methods/analyses to test "treatment mechanisms" in a sample of newly diagnosed youth with
      ADHD (Phase III) and finalize the IPFAC procedural manual.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Attendance at BPT sessions
time frame: 16 Weeks
description: Family Practice Associates (FPAs) will provide information on the extent to which the family attended scheduled BPT sessions.
measure: Parenting Behavior
time frame: 16 Weeks
description: The Alabama Parenting Questionnaire- Short Form (APQ-SF) is a well-validated 9-item measure of parenting style. Items are rated by the parent scored based on frequency of parenting behavior from Never (1), Almost Never (2), Sometimes (3), Often (4), Always (5). APQ-SF items are based around the three main structures: positive parenting, inconsistent discipline and poor supervision.
measure: ADHD and oppositional behavior will be measured by the IOWA Connors Rating Scale (IOWA-CRS)
time frame: 16 Weeks
description: The IOWA-CRS (Waschbusch & Willoughby, 2008) is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. The IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3).
measure: Parental Depressive Symptoms using Beck Depression Inventory-II
time frame: 16 Weeks
description: a 21-item self-report measure used to assess maternal depressive symptoms. Mothers were instructed to indicate which of four statements best described how they felt over the preceding two week period. The BDI is scored from one to four, with higher scores on the BDI indicating a greater degree of depression. A total score on the BDI, which is a sum of the 21-item measure, will be used in the study.
arm group label: Parent
arm group type: Experimental
description: Parent of a child who is a patient at the NYU Bellevue Attention Deficit Hyperactivity Disorder (ADHD) Clinic
intervention type: Behavioral
intervention name: Behavioral Parent Training (BPT)
description: A specific intervention modality that has been shown to improve key functional outcomes in youth with ADHD.
arm group label: Parent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karen Hopkins, MD
role: Principal Investigator
affiliation: NYU Langone Pediatric Department
facility: 
country: United States
responsible party type: Sponsor