<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/NCT04473755</url>
  </required_header>
  <id_info>
    <org_study_id>800012103</org_study_id>
    <nct_id>NCT04473755</nct_id>
  </id_info>
  <brief_title>A Naturalistic Study of Functional Impairment for Individuals With ADHD in the Early Morning and Late Afternoon/Evening Hours</brief_title>
  <official_title>A Naturalistic Study of Functional Impairment for Individuals With ADHD in the Early Morning and Late Afternoon/Evening Hours</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 objective of this study is to assess the burden and impact of ADHD impairment in the&#xD;
      early morning and late afternoon/evening hours for adolescents and young adults. Functional&#xD;
      impairments will focus on the currently identified areas of functional impairment in the&#xD;
      Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric&#xD;
      Association, 2013) - namely, social, academic, and occupational functioning. This is&#xD;
      necessary for two reasons: (1) the current literature on ADHD impairment and functioning is&#xD;
      concentrated within elementary school children; and (2) studies of intervention effectiveness&#xD;
      are typically concentrated during the school day. This current state of the literature&#xD;
      ignores the obvious - as ADHD is a chronic disorder, it needs to be addressed as children&#xD;
      grow into adolescence and young adulthood, and it needs to be remediated at times outside of&#xD;
      the school day such as in the morning and late afternoon/evening.&#xD;
&#xD;
      Therefore, the specific areas assessed in the present study will relate to driving, school,&#xD;
      work, and family functioning. These are important areas to study, as the research literature&#xD;
      has typically focused on elementary school and school-day behavior in assessments of symptom&#xD;
      presentation, impairment, and treatment outcome. As individuals with ADHD grow older, the&#xD;
      entire day becomes relevant in determinations of functioning (e.g., workdays may begin in the&#xD;
      very early morning or last into the evening/night), and productivity can be assessed across&#xD;
      waking hours rather than just across the elementary school day. Once areas of functional&#xD;
      impairment in these times of day are determined, for this age group, treatment candidates can&#xD;
      aim to address these treatment targets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study aims are as follows:&#xD;
&#xD;
        1. To investigate the impairment present in the morning and late afternoon/evening for&#xD;
           individuals with ADHD, relative to a non-ADHD group.&#xD;
&#xD;
           a. Hypothesis: Individuals with ADHD will illustrate more impaired functioning in the&#xD;
           morning and late afternoon/evening, relative to a non-ADHD group in the following&#xD;
           domains: i. Risky Driving ii. School/Workplace related behavior (e.g., time on-task in&#xD;
           the evening, management of weekly schedule) iii. Family and social functioning&#xD;
&#xD;
        2. Develop a set of recommendations for the evidence-based assessment of morning and late&#xD;
           afternoon/evening behavior of individuals with ADHD.&#xD;
&#xD;
             1. Hypothesis: It is hypothesized that a multi-method, multi-domain assessment of&#xD;
                impaired functioning will yield the most clinically defensible assessment approach.&#xD;
&#xD;
      Rolling enrollment will be used in this study. Participants will attend an intake visit to&#xD;
      provide informed consent for participation in the study, and collect baseline and diagnostic&#xD;
      information. The targeted population will be youth and young adults between the ages of 16-30&#xD;
      with a valid driver permit or license. To determine eligibility for the study, participants&#xD;
      will complete (1) a self-report of ADHD symptoms (Molina, Smith, &amp; Pelham, 2001; Pelham,&#xD;
      Gnagy, Greenslade, &amp; Milich, 1992), (2) the Impairment Rating Scale (Fabiano et al., 2006;&#xD;
      Sibley et al., 2012a); and (3) a semi-structured Disruptive Behavior Disorders interview with&#xD;
      a clinician to obtain contextual information on symptoms and impairment over the last six&#xD;
      months (Hartung et al, 2005). Participants will also complete the WASI-2 to ascertain an&#xD;
      estimate of IQ. Additionally, a collateral rater (i.e., parent or significant other; Sibley&#xD;
      et al., 2012a, 2012b) will report on the participant's ADHD symptom ratings for the past six&#xD;
      months and retrospectively provide a report on childhood symptoms. The collateral rater will&#xD;
      also complete an Impairment Rating Scale based on the last six months. Participants will be&#xD;
      classified as ADHD if there are at least 4 symptoms of inattentive and/or&#xD;
      hyperactive-impulsive behaviors endorsed at clinically significant levels, evidence of onset&#xD;
      of ADHD prior to age 12, and current psychosocial impairment (Sibley et al., 2012a, 2012b).&#xD;
&#xD;
      To reduce variability between the ADHD and non-ADHD groups, we will match participants on age&#xD;
      (+/- 2 years), sex, and whether they are employed or unemployed.&#xD;
&#xD;
      Eligible participants in either the ADHD or non-ADHD group will then have a meeting with the&#xD;
      research team to initiate data collection methods over a two-week time period (i.e., 14 early&#xD;
      morning and 14 late afternoon/evening assessments; N=28 assessments/participant total). This&#xD;
      amount of repeated measurement should be adequate for detecting differences in participants&#xD;
      (e.g., Ferguson et al., 2012). To accurately capture the diverse array of potential&#xD;
      functional impairments in the early morning and late afternoon/evening hours, a multi-method&#xD;
      approach to data collection will be utilized. The keystone of the data collection process&#xD;
      will be via the adolescent/young adult's smart phone. In our data collection approach we will&#xD;
      use commercially available and commonly employed (e.g., smartphones) measurement tools to&#xD;
      develop a method of data collection that may be eventually appropriate for scale in the&#xD;
      adolescent/young adult population. Using an application that permits geo-location,&#xD;
      information on driving, and timestamps for location (e.g., Life360.com), the participants'&#xD;
      self-management within key functional domains will be assessed. The following data will be&#xD;
      collected:&#xD;
&#xD;
      Morning and Evening Routine. Participants will provide a weekly schedule for the upcoming&#xD;
      week. Using this information, mobile technology will be used to determine success with&#xD;
      meeting expectations for morning routine (e.g., waking up; leaving for school/work; falling&#xD;
      asleep). Mobile technology will track sleeping habit and time of wakening, and geo-fencing&#xD;
      will set an alert when the participant leaves the home. Using an idiographic list of&#xD;
      responsibilities for work/school/home, we will monitor performance toward goal attainment as&#xD;
      we have done in related studies in the natural and laboratory setting (Fabiano et al., 2010;&#xD;
      Fabiano et al., 2018).&#xD;
&#xD;
      Driving. Early morning and late afternoon/evening driving will be monitored using the&#xD;
      participants' smartphone application, which includes the Driver Protect feature. Driver&#xD;
      Protect includes driving reports that include potentially unsafe behaviors (phone use to text&#xD;
      while driving, speeding, hard braking, collisions) as well as 30 days of location history. We&#xD;
      will collect companion driving performance information using the Life360 app which will log&#xD;
      all trips conducted by the driver, total miles traveled, record top speed for each trip, and&#xD;
      record frequency counts of hard/extreme braking and acceleration. Similar tools have been&#xD;
      successfully used in prior studies (Fabiano et al., 2011; Fabiano et al., 2016) and they are&#xD;
      well-tolerated by participants.&#xD;
&#xD;
      Family and Social Functioning. Ecological, momentary assessment will be used to assess family&#xD;
      and social functioning based on report from both the participant and identified&#xD;
      collateral(s). Ecological, momentary assessment is an approach that uses a smartphone based&#xD;
      prompt (i.e., in a text message) to ask the participant about behavior/functioning/mood at&#xD;
      that moment (e.g., Miguelez-Fernandez, et al., 2018). Participants and collaterals will be&#xD;
      contacted in the early morning and late afternoon/evening hours to obtain information on&#xD;
      typical activities, individuals they are interacting with, and to obtain a brief rating of&#xD;
      functional impairment using the Impairment Rating Scale (Fabiano et al., 2006). Participants&#xD;
      and collaterals will be contacted at least once each morning and once each afternoon/evening&#xD;
      daily, for two weeks.&#xD;
&#xD;
      ADHD Symptoms and Impairment. As part of the assessment of family and social functioning&#xD;
      probes, we will also administer a brief probe of ADHD symptoms and impairment. We will&#xD;
      include the six symptoms from the Adult ADHD Self-Report Scale (Kessler, et al., 2007) and&#xD;
      the overall impairment item on the Impairment Rating Scale (Fabiano et al., 2006). Data for&#xD;
      this measure will be collected during both the early morning and late afternoon/evening&#xD;
      assessment periods.&#xD;
&#xD;
      Our prior work illustrated little reactivity with observations of behavior, even in&#xD;
      high-profile situations such as driving. Indeed, when teenagers with ADHD (16-18) had their&#xD;
      cars outfitted with on-board cameras facing the cabin and the roadway, there was no&#xD;
      difference in rates of risky driving during the first and last weeks (Fabiano et al., 2016),&#xD;
      and collaterals (parents) and teens illustrated coercive interactions strategies during these&#xD;
      on-board assessments (Schatz, Fabiano et al., 2014). In addition, parenting and teen&#xD;
      behaviors in the laboratory regarding a conflictual topic yielded sufficient behavioral&#xD;
      variability across positive and negative parent/teen behaviors (Fabiano et al., 2016); it is&#xD;
      expected that in-home, ecological, momentary assessment will be even more effective at&#xD;
      generating information on social functioning. These results suggest that there will be&#xD;
      acceptable rates of behavioral variability during the two-week assessment period and this is&#xD;
      also an assessment period of reasonable length to prevent attrition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Social Impairment</measure>
    <time_frame>14 days</time_frame>
    <description>Ecological, momentary assessment of social interaction impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADHD symptoms</measure>
    <time_frame>14 days</time_frame>
    <description>Ecological, momentary assessment of ADHD symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Driving behavior</measure>
    <time_frame>14 days</time_frame>
    <description>Sum of risky driving events (e.g., texting while driving; hard braking or acceleration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Behavioral Goals Met</measure>
    <time_frame>14 days</time_frame>
    <description>Percent of daily schedule goals met on time</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>ADHD</arm_group_label>
    <description>This group will include participants who meet DSM-5 diagnostic criteria for ADHD and meet all other study inclusion criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-ADHD</arm_group_label>
    <description>This group will include participants who do not meet DSM-5 diagnostic criteria for ADHD and meet all other study inclusion criteria.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be between 16-30 years of age and have an identified collateral rater&#xD;
        (e.g., parent, partner). Half of the participants will have ADHD and the other half will&#xD;
        not meet diagnostic criteria for ADHD. To reduce variability between the ADHD and non-ADHD&#xD;
        groups, we will match participants on age (+/- 2 years), sex, and whether they are employed&#xD;
        or unemployed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants will have an estimated IQ greater than 70, a valid driving license/permit,&#xD;
        and no evidence of psychosis or autism spectrum disorder at level 2 or 3. Individuals will&#xD;
        be classified in the ADHD group if they meet DSM-5 criteria for ADHD based on the&#xD;
        evaluation. Individuals who do not meet criteria for ADHD will be placed in the non-ADHD&#xD;
        group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Medication use for ADHD will be an exclusion criteria, unless the participant works with&#xD;
        the prescribing physician to take a 2-week holiday from medication for the duration of the&#xD;
        study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory A Fabiano</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida International University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Children and Families</name>
      <address>
        <city>Amherst</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>February 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD; impairment; symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <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/NCT04473755
org study id: 800012103
nct id: NCT04473755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to assess the burden and impact of ADHD impairment in the
      early morning and late afternoon/evening hours for adolescents and young adults. Functional
      impairments will focus on the currently identified areas of functional impairment in the
      Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric
      Association, 2013) - namely, social, academic, and occupational functioning. This is
      necessary for two reasons: (1) the current literature on ADHD impairment and functioning is
      concentrated within elementary school children; and (2) studies of intervention effectiveness
      are typically concentrated during the school day. This current state of the literature
      ignores the obvious - as ADHD is a chronic disorder, it needs to be addressed as children
      grow into adolescence and young adulthood, and it needs to be remediated at times outside of
      the school day such as in the morning and late afternoon/evening.

      Therefore, the specific areas assessed in the present study will relate to driving, school,
      work, and family functioning. These are important areas to study, as the research literature
      has typically focused on elementary school and school-day behavior in assessments of symptom
      presentation, impairment, and treatment outcome. As individuals with ADHD grow older, the
      entire day becomes relevant in determinations of functioning (e.g., workdays may begin in the
      very early morning or last into the evening/night), and productivity can be assessed across
      waking hours rather than just across the elementary school day. Once areas of functional
      impairment in these times of day are determined, for this age group, treatment candidates can
      aim to address these treatment targets.
Study aims are as follows:

        1. To investigate the impairment present in the morning and late afternoon/evening for
           individuals with ADHD, relative to a non-ADHD group.

           a. Hypothesis: Individuals with ADHD will illustrate more impaired functioning in the
           morning and late afternoon/evening, relative to a non-ADHD group in the following
           domains: i. Risky Driving ii. School/Workplace related behavior (e.g., time on-task in
           the evening, management of weekly schedule) iii. Family and social functioning

        2. Develop a set of recommendations for the evidence-based assessment of morning and late
           afternoon/evening behavior of individuals with ADHD.

             1. Hypothesis: It is hypothesized that a multi-method, multi-domain assessment of
                impaired functioning will yield the most clinically defensible assessment approach.

      Rolling enrollment will be used in this study. Participants will attend an intake visit to
      provide informed consent for participation in the study, and collect baseline and diagnostic
      information. The targeted population will be youth and young adults between the ages of 16-30
      with a valid driver permit or license. To determine eligibility for the study, participants
      will complete (1) a self-report of ADHD symptoms (Molina, Smith, & Pelham, 2001; Pelham,
      Gnagy, Greenslade, & Milich, 1992), (2) the Impairment Rating Scale (Fabiano et al., 2006;
      Sibley et al., 2012a); and (3) a semi-structured Disruptive Behavior Disorders interview with
      a clinician to obtain contextual information on symptoms and impairment over the last six
      months (Hartung et al, 2005). Participants will also complete the WASI-2 to ascertain an
      estimate of IQ. Additionally, a collateral rater (i.e., parent or significant other; Sibley
      et al., 2012a, 2012b) will report on the participant's ADHD symptom ratings for the past six
      months and retrospectively provide a report on childhood symptoms. The collateral rater will
      also complete an Impairment Rating Scale based on the last six months. Participants will be
      classified as ADHD if there are at least 4 symptoms of inattentive and/or
      hyperactive-impulsive behaviors endorsed at clinically significant levels, evidence of onset
      of ADHD prior to age 12, and current psychosocial impairment (Sibley et al., 2012a, 2012b).

      To reduce variability between the ADHD and non-ADHD groups, we will match participants on age
      (+/- 2 years), sex, and whether they are employed or unemployed.

      Eligible participants in either the ADHD or non-ADHD group will then have a meeting with the
      research team to initiate data collection methods over a two-week time period (i.e., 14 early
      morning and 14 late afternoon/evening assessments; N=28 assessments/participant total). This
      amount of repeated measurement should be adequate for detecting differences in participants
      (e.g., Ferguson et al., 2012). To accurately capture the diverse array of potential
      functional impairments in the early morning and late afternoon/evening hours, a multi-method
      approach to data collection will be utilized. The keystone of the data collection process
      will be via the adolescent/young adult's smart phone. In our data collection approach we will
      use commercially available and commonly employed (e.g., smartphones) measurement tools to
      develop a method of data collection that may be eventually appropriate for scale in the
      adolescent/young adult population. Using an application that permits geo-location,
      information on driving, and timestamps for location (e.g., Life360.com), the participants'
      self-management within key functional domains will be assessed. The following data will be
      collected:

      Morning and Evening Routine. Participants will provide a weekly schedule for the upcoming
      week. Using this information, mobile technology will be used to determine success with
      meeting expectations for morning routine (e.g., waking up; leaving for school/work; falling
      asleep). Mobile technology will track sleeping habit and time of wakening, and geo-fencing
      will set an alert when the participant leaves the home. Using an idiographic list of
      responsibilities for work/school/home, we will monitor performance toward goal attainment as
      we have done in related studies in the natural and laboratory setting (Fabiano et al., 2010;
      Fabiano et al., 2018).

      Driving. Early morning and late afternoon/evening driving will be monitored using the
      participants' smartphone application, which includes the Driver Protect feature. Driver
      Protect includes driving reports that include potentially unsafe behaviors (phone use to text
      while driving, speeding, hard braking, collisions) as well as 30 days of location history. We
      will collect companion driving performance information using the Life360 app which will log
      all trips conducted by the driver, total miles traveled, record top speed for each trip, and
      record frequency counts of hard/extreme braking and acceleration. Similar tools have been
      successfully used in prior studies (Fabiano et al., 2011; Fabiano et al., 2016) and they are
      well-tolerated by participants.

      Family and Social Functioning. Ecological, momentary assessment will be used to assess family
      and social functioning based on report from both the participant and identified
      collateral(s). Ecological, momentary assessment is an approach that uses a smartphone based
      prompt (i.e., in a text message) to ask the participant about behavior/functioning/mood at
      that moment (e.g., Miguelez-Fernandez, et al., 2018). Participants and collaterals will be
      contacted in the early morning and late afternoon/evening hours to obtain information on
      typical activities, individuals they are interacting with, and to obtain a brief rating of
      functional impairment using the Impairment Rating Scale (Fabiano et al., 2006). Participants
      and collaterals will be contacted at least once each morning and once each afternoon/evening
      daily, for two weeks.

      ADHD Symptoms and Impairment. As part of the assessment of family and social functioning
      probes, we will also administer a brief probe of ADHD symptoms and impairment. We will
      include the six symptoms from the Adult ADHD Self-Report Scale (Kessler, et al., 2007) and
      the overall impairment item on the Impairment Rating Scale (Fabiano et al., 2006). Data for
      this measure will be collected during both the early morning and late afternoon/evening
      assessment periods.

      Our prior work illustrated little reactivity with observations of behavior, even in
      high-profile situations such as driving. Indeed, when teenagers with ADHD (16-18) had their
      cars outfitted with on-board cameras facing the cabin and the roadway, there was no
      difference in rates of risky driving during the first and last weeks (Fabiano et al., 2016),
      and collaterals (parents) and teens illustrated coercive interactions strategies during these
      on-board assessments (Schatz, Fabiano et al., 2014). In addition, parenting and teen
      behaviors in the laboratory regarding a conflictual topic yielded sufficient behavioral
      variability across positive and negative parent/teen behaviors (Fabiano et al., 2016); it is
      expected that in-home, ecological, momentary assessment will be even more effective at
      generating information on social functioning. These results suggest that there will be
      acceptable rates of behavioral variability during the two-week assessment period and this is
      also an assessment period of reasonable length to prevent attrition.
observational model: Case-Control
time perspective: Prospective
measure: Social Impairment
time frame: 14 days
description: Ecological, momentary assessment of social interaction impairment
measure: ADHD symptoms
time frame: 14 days
description: Ecological, momentary assessment of ADHD symptoms
measure: Driving behavior
time frame: 14 days
description: Sum of risky driving events (e.g., texting while driving; hard braking or acceleration
measure: Percent of Behavioral Goals Met
time frame: 14 days
description: Percent of daily schedule goals met on time
arm group label: ADHD
description: This group will include participants who meet DSM-5 diagnostic criteria for ADHD and meet all other study inclusion criteria.
arm group label: Non-ADHD
description: This group will include participants who do not meet DSM-5 diagnostic criteria for ADHD and meet all other study inclusion criteria.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory A Fabiano
role: Principal Investigator
affiliation: Florida International University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No