xml: <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/NCT06012851</url>
    </required_header>
    <id_info>
      <org_study_id>1R34MH128513-01</org_study_id>
      <nct_id>NCT06012851</nct_id>
    </id_info>
    <brief_title>Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial</brief_title>
    <official_title>Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With Attention Deficit Hyperactivity Disorder (ADHD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Florida International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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 goal of the study is to develop and refine a personalized behavioral parent training&#xD;
        intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD).&#xD;
        The behavioral intervention will teach positive parenting through videos and quizzes that&#xD;
        caregivers can access through a smartphone application. The program also gives parents and&#xD;
        caregivers in-the-moment feedback their use of parenting strategies. The current study, a&#xD;
        micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a&#xD;
        push notification on their smartphone) changes parenting behavior right after the feedback.&#xD;
        Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple&#xD;
        times per day, to receive or not receive parenting feedback or suggestions on their&#xD;
        smartphones.&#xD;
  &#xD;
        The main questions to answer are:&#xD;
  &#xD;
        Is parenting feedback provided by a smartphone application acceptable to caregivers? When&#xD;
        parents receive the feedback, do they use more positive parenting skills in the next few&#xD;
        minutes compared to when they do not receive the feedback? Is the phone application usable&#xD;
        and acceptable to parents and caregivers of children with attention deficit hyperactivity&#xD;
        disorder?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</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>
      <intervention_model_description>All participants receive access to a beta version of the mobile behavioral parent training application. Each participant is randomized multiple times per day (about 4-6 times per day) to received either no push notification (50% chance) or a push notification providing parenting feedback or a suggestion to use a parenting strategy (50% chance).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Passive Audio Data-Positive Sentiment Analysis</measure>
      <time_frame>Through study completion, average of 5 weeks</time_frame>
      <description>Parent and child interaction behavior- proportion of recorded interaction that is labeled positive via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Passive Audio Data-Negative Sentiment Analysis</measure>
      <time_frame>Throughout study completion, average of 5 weeks</time_frame>
      <description>Parent and child interaction behavior- proportion of recorded interaction that is labeled negative via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intervention Engagement</measure>
      <time_frame>Through study completion, average of 5 weeks</time_frame>
      <description>Number of mobile BPT sessions completed divided by the total number of sessions available.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Attention Deficit Hyperactivity Disorder</condition>
    <arm_group>
      <arm_group_label>Mobile BPT with in-the-moment feedback</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be randomized multiple times per day to receive either a push notification related to parenting behavior or no push notification.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mobile behavioral parent training (mBPT) and prompts</intervention_name>
      <description>The mobile phone application includes behavioral parent training content (for example, praise, effective commands, reward systems) delivered in videos, examples, and quizzes that parents/caregivers access. In-the-moment feedback will include parenting feedback and parenting strategies.</description>
      <arm_group_label>Mobile BPT with in-the-moment feedback</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD&#xD;
  &#xD;
            -  Ages 7 -12&#xD;
  &#xD;
            -  Has parent-reported impairment in homework performance defined as a score of 3 or&#xD;
               greater on an Impairment Rating Scale measure (Fabiano et al., 2006) of homework&#xD;
               performance&#xD;
  &#xD;
            -  Has at least one parent or primary caregiver who is willing to participate and is able&#xD;
               to access the intervention at home via smartphone.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  N/A&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Brittany Merrill, Ph.D</last_name>
      <phone>7163595773</phone>
      <email>brmerril@fiu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Center for Children and Families of Western New York</name>
        <address>
          <city>Buffalo</city>
          <state>New York</state>
          <zip>14226</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</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>Hyperkinesis</mesh_term>
      <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012851
  org study id: 1R34MH128513-01
  nct id: NCT06012851
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the study is to develop and refine a personalized behavioral parent training
        intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD).
        The behavioral intervention will teach positive parenting through videos and quizzes that
        caregivers can access through a smartphone application. The program also gives parents and
        caregivers in-the-moment feedback their use of parenting strategies. The current study, a
        micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a
        push notification on their smartphone) changes parenting behavior right after the feedback.
        Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple
        times per day, to receive or not receive parenting feedback or suggestions on their
        smartphones.
  
        The main questions to answer are:
  
        Is parenting feedback provided by a smartphone application acceptable to caregivers? When
        parents receive the feedback, do they use more positive parenting skills in the next few
        minutes compared to when they do not receive the feedback? Is the phone application usable
        and acceptable to parents and caregivers of children with attention deficit hyperactivity
        disorder?
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All participants receive access to a beta version of the mobile behavioral parent training application. Each participant is randomized multiple times per day (about 4-6 times per day) to received either no push notification (50% chance) or a push notification providing parenting feedback or a suggestion to use a parenting strategy (50% chance).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Passive Audio Data-Positive Sentiment Analysis
  time frame: Through study completion, average of 5 weeks
  description: Parent and child interaction behavior- proportion of recorded interaction that is labeled positive via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.
  measure: Passive Audio Data-Negative Sentiment Analysis
  time frame: Throughout study completion, average of 5 weeks
  description: Parent and child interaction behavior- proportion of recorded interaction that is labeled negative via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.
  measure: Intervention Engagement
  time frame: Through study completion, average of 5 weeks
  description: Number of mobile BPT sessions completed divided by the total number of sessions available.
  arm group label: Mobile BPT with in-the-moment feedback
  arm group type: Experimental
  description: Participants will be randomized multiple times per day to receive either a push notification related to parenting behavior or no push notification.
  intervention type: Behavioral
  intervention name: Mobile behavioral parent training (mBPT) and prompts
  description: The mobile phone application includes behavioral parent training content (for example, praise, effective commands, reward systems) delivered in videos, examples, and quizzes that parents/caregivers access. In-the-moment feedback will include parenting feedback and parenting strategies.
  arm group label: Mobile BPT with in-the-moment feedback
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Brittany Merrill, Ph.D
  phone: 7163595773
  email: brmerril@fiu.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hyperkinesis
  mesh term: Attention Deficit Disorder with Hyperactivity
  sharing ipd: Undecided