<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/NCT04402528</url>
  </required_header>
  <id_info>
    <org_study_id>2019-1274</org_study_id>
    <nct_id>NCT04402528</nct_id>
  </id_info>
  <brief_title>Preschool ADHD On-line Behavioral Treatment</brief_title>
  <official_title>Improving Rates of Behavioral Treatment in Preschoolers Through Mehealth for ADHD Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Developmental Behavioral Pediatrics Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HRSA/Maternal and Child Health Bureau</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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 primary goal of the proposed project is to test the feasibility of parent and&#xD;
      teacher/childcare providers use of the ADHD web portal-integrated behavioral treatment&#xD;
      modules with preschool children with ADHD in order to improve the access to and the integrity&#xD;
      of evidence-based behavioral treatment strategies for young children with ADHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although behavioral interventions are the recommended first-line treatment for preschool&#xD;
      children with Attention Deficit Hyperactivity Disorder (ADHD), the majority of preschool&#xD;
      children receiving treatment for ADHD are treated with medication only. Barriers to preschool&#xD;
      children receiving behavioral treatments include financial limitations, family logistical&#xD;
      challenges, and the paucity of trained providers. Web-based approaches may be one innovative&#xD;
      way to address these obstacles. Thus, the goal of the proposed study is to pilot-test an&#xD;
      on-line behavioral intervention that has been integrated into the evidence-based mehealth for&#xD;
      ADHD software (mehealth.com) to determine feasibility, acceptability, and preliminary&#xD;
      efficacy. The investigators will enroll a community-based sample of caregivers and&#xD;
      teachers/childcare providers of 20 preschool children with ADHD recruited from two DBPNet&#xD;
      sites (Cincinnati and Boston) who will utilize the on-line behavioral tools to create and&#xD;
      implement child behavior plans. The investigators will track system usage over a 9-month&#xD;
      period to determine feasibility for mehealth's integrated behavioral tools intervention.&#xD;
      Standardized measures and open-ended questions will be used to determine the intervention's&#xD;
      acceptability to parents and teachers/childcare providers. In addition, parent and&#xD;
      teacher/childcare providers ratings of child ADHD symptoms and impairment collected at&#xD;
      baseline and at the 3-month, 6-month, and 9-month time points will be examined to provide&#xD;
      preliminary estimates of efficacy. Ultimately, development of the mehealth for ADHD.com&#xD;
      integrated behavioral tools may provide a cost-effective and convenient means of implementing&#xD;
      behavioral plans for young children, thereby increasing access to behavioral treatments for&#xD;
      preschoolers with ADHD. This scalable and disseminatable approach has great potential for use&#xD;
      not only in clinical settings, but also in national Developmental-Behavioral Pediatrics&#xD;
      Research Network multi-site research studies which require standardized behavioral&#xD;
      intervention packages for preschool ADHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2020</start_date>
  <completion_date type="Actual">May 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% of days using mehealth behavior tracking system</measure>
    <time_frame>9 months</time_frame>
    <description>Feasibility will be assessed by tracking system usage, including % of days when parents/teachers/childcare providers entered behavioral tracking data (to determine if data was entered for &gt;85% of days) and % of days when earned rewards were administered (to determine if administration occurred for &gt;85% of days).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability with on-line behavioral treatment assessed by the System Usability Scale</measure>
    <time_frame>9 months</time_frame>
    <description>System Usability Scale contains ten items rated on a Likert scale.&#xD;
- SUS contains ten items rated on a Likert scale.&#xD;
Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire (IAQ).&#xD;
- The IAQ contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire</measure>
    <time_frame>9 months</time_frame>
    <description>The Intervention Acceptability Questionnaire contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ADHD Rating Scale-IV-Preschool Version</measure>
    <time_frame>9 months</time_frame>
    <description>Descriptive statistics from parent-rated ADHD Rating Scale-IV-Preschool Version total symptom scores will be reported across time points. Please note that the word &quot;ADHD&quot; is not used as an abbreviation in &quot;ADHD Rating Scale - IV - Preschool Version,&quot; that is the official name of the scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impairment Rating Scale</measure>
    <time_frame>9 months</time_frame>
    <description>Descriptive statistics from parent-rated Impairment Rating Scale total symptom scores will be reported across time points</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>mehealth portal with integrated behavioral tools</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will use the mehealth for ADHD web-based software and have access to a module that allows parents and teachers/childcare providers to develop and implement behavioral interventions such as daily report cards online.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral tools integrated within mehealth for ADHD software</intervention_name>
    <description>Integrated functionality within the mehealth for ADHD software allows parents and teachers/childcare providers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly.</description>
    <arm_group_label>mehealth portal with integrated behavioral tools</arm_group_label>
    <other_name>mehealth for ADHD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child has been diagnosed with ADHD, or shows significant signs and symptoms of ADHD.&#xD;
&#xD;
          -  If child is being prescribed ADHD medication, child must currently be on a stable&#xD;
             dosage of medication for 1 month.&#xD;
&#xD;
          -  Child meets criteria for a research diagnosis of ADHD* based on the ADHD Rating Scale&#xD;
             IV Preschool-Version and Impairment Rating Scale assessments that the parent&#xD;
             completes.&#xD;
&#xD;
               -  Children will be given a research diagnosis of ADHD if the following criteria are&#xD;
                  met: 1) parents endorse that children have 6 or more symptoms in either the&#xD;
                  inattentive or hyperactive-impulsive domains present &quot;often&quot; or &quot;very often&quot; on&#xD;
                  the ADHD Rating Scale IV-Preschool Version (ADHD-RS-IV-P) or Vanderbilt ADHD&#xD;
                  Rating Scale; or have inattentive symptom scores and/or hyperactive symptom&#xD;
                  scores &gt;93th percentile for sex on the ADHD-RS-IV-P AND 2) child is experiencing&#xD;
                  ADHD-related impairment as shown by the parent or a teacher/childcare&#xD;
                  provider/additional adult scoring one or more items on the Impairment Rating&#xD;
                  Scale as a 3 or higher. Note: child behavior ratings from a teacher/childcare&#xD;
                  provider/additional adult on the ADHD-RS-IV-P and Impairment Rating Scale will&#xD;
                  not be required for study inclusion and children will not be excluded from the&#xD;
                  study on the basis of these ratings. Parents of children with a research&#xD;
                  diagnosis of ADHD will be eligible for study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent does not have access to a computer or smartphone.&#xD;
&#xD;
          -  Child has global developmental delay.&#xD;
&#xD;
          -  Child has been diagnosed with autism spectrum disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tanya Froehlich, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Medical Center, Cincinnati</investigator_affiliation>
    <investigator_full_name>Tanya Froehlich, MD</investigator_full_name>
    <investigator_title>Professor of Pediatrics and Director of Research</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04402528
org study id: 2019-1274
nct id: NCT04402528
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary goal of the proposed project is to test the feasibility of parent and
      teacher/childcare providers use of the ADHD web portal-integrated behavioral treatment
      modules with preschool children with ADHD in order to improve the access to and the integrity
      of evidence-based behavioral treatment strategies for young children with ADHD.
Although behavioral interventions are the recommended first-line treatment for preschool
      children with Attention Deficit Hyperactivity Disorder (ADHD), the majority of preschool
      children receiving treatment for ADHD are treated with medication only. Barriers to preschool
      children receiving behavioral treatments include financial limitations, family logistical
      challenges, and the paucity of trained providers. Web-based approaches may be one innovative
      way to address these obstacles. Thus, the goal of the proposed study is to pilot-test an
      on-line behavioral intervention that has been integrated into the evidence-based mehealth for
      ADHD software (mehealth.com) to determine feasibility, acceptability, and preliminary
      efficacy. The investigators will enroll a community-based sample of caregivers and
      teachers/childcare providers of 20 preschool children with ADHD recruited from two DBPNet
      sites (Cincinnati and Boston) who will utilize the on-line behavioral tools to create and
      implement child behavior plans. The investigators will track system usage over a 9-month
      period to determine feasibility for mehealth's integrated behavioral tools intervention.
      Standardized measures and open-ended questions will be used to determine the intervention's
      acceptability to parents and teachers/childcare providers. In addition, parent and
      teacher/childcare providers ratings of child ADHD symptoms and impairment collected at
      baseline and at the 3-month, 6-month, and 9-month time points will be examined to provide
      preliminary estimates of efficacy. Ultimately, development of the mehealth for ADHD.com
      integrated behavioral tools may provide a cost-effective and convenient means of implementing
      behavioral plans for young children, thereby increasing access to behavioral treatments for
      preschoolers with ADHD. This scalable and disseminatable approach has great potential for use
      not only in clinical settings, but also in national Developmental-Behavioral Pediatrics
      Research Network multi-site research studies which require standardized behavioral
      intervention packages for preschool ADHD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % of days using mehealth behavior tracking system
time frame: 9 months
description: Feasibility will be assessed by tracking system usage, including % of days when parents/teachers/childcare providers entered behavioral tracking data (to determine if data was entered for >85% of days) and % of days when earned rewards were administered (to determine if administration occurred for >85% of days).
measure: Acceptability with on-line behavioral treatment assessed by the System Usability Scale
time frame: 9 months
description: System Usability Scale contains ten items rated on a Likert scale.
- SUS contains ten items rated on a Likert scale.
Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire (IAQ).
- The IAQ contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program.
measure: Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire
time frame: 9 months
description: The Intervention Acceptability Questionnaire contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program
measure: ADHD Rating Scale-IV-Preschool Version
time frame: 9 months
description: Descriptive statistics from parent-rated ADHD Rating Scale-IV-Preschool Version total symptom scores will be reported across time points. Please note that the word "ADHD" is not used as an abbreviation in "ADHD Rating Scale - IV - Preschool Version," that is the official name of the scale.
measure: Impairment Rating Scale
time frame: 9 months
description: Descriptive statistics from parent-rated Impairment Rating Scale total symptom scores will be reported across time points
arm group label: mehealth portal with integrated behavioral tools
arm group type: Experimental
description: Patients in this arm will use the mehealth for ADHD web-based software and have access to a module that allows parents and teachers/childcare providers to develop and implement behavioral interventions such as daily report cards online.
intervention type: Behavioral
intervention name: Behavioral tools integrated within mehealth for ADHD software
description: Integrated functionality within the mehealth for ADHD software allows parents and teachers/childcare providers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly.
arm group label: mehealth portal with integrated behavioral tools
other name: mehealth for ADHD
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: No
last name: Tanya Froehlich, MD, MS
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Medical Center, Cincinnati
investigator full name: Tanya Froehlich, MD
investigator title: Professor of Pediatrics and Director of Research
sharing ipd: No