<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/NCT04480346</url>
  </required_header>
  <id_info>
    <org_study_id>R305A140356 - 15</org_study_id>
    <nct_id>NCT04480346</nct_id>
  </id_info>
  <brief_title>Multisite Study of High School-based Treatment for Adolescents With ADHD</brief_title>
  <official_title>Multisite Study of School-based Treatment Approaches for Adolescents With ADHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lehigh University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio 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>
      We evaluated the extent to which receiving the school-based multi-component treatment of the&#xD;
      Challenging Horizons Program (CHP) would lead to significant improvements in levels of&#xD;
      symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic&#xD;
      functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200&#xD;
      high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to&#xD;
      either CHP or a Community Care condition within each of 12 participating high schools.&#xD;
      Outcome measures included parent, teacher and adolescent reports as well as observational&#xD;
      data. Measures were collected at initial evaluations which preceded the one academic year of&#xD;
      treatment, during the treatment period, and at six-months after treatment ended. Based on&#xD;
      previous research with this treatment in middle and high schools, we anticipated meaningful&#xD;
      gains for those in the treatment condition at post-treatment and larger gains on some&#xD;
      variables at the 6-month follow-up evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We evaluated the extent to which receiving the school-based multi-component treatment of the&#xD;
      Challenging Horizons Program (CHP) would lead to significant improvements in levels of&#xD;
      symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic&#xD;
      functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200&#xD;
      high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to&#xD;
      either CHP or a Community Care condition within each of 12 participating high schools.&#xD;
      Outcome measures included parent, teacher and adolescent reports as well as observational&#xD;
      data. Measures were collected at initial evaluations which preceded the one academic year of&#xD;
      treatment, during the treatment period, and at six-months after treatment ended. Based on&#xD;
      previous research with this treatment in middle and high schools, we anticipated meaningful&#xD;
      gains for those in the treatment condition at post-treatment and larger gains on some&#xD;
      variables at the 6-month follow-up evaluation. Eligible participants were stratified for&#xD;
      medication status and sex following the completion of all eligibility assessments for each of&#xD;
      3 cohorts and were randomly assigned (within schools) to either the CHP or CC condition.&#xD;
      Siblings were assigned together such that they would be in the same condition. All measures&#xD;
      (except the achievement test which was given at eligibility and post-treatment assessment&#xD;
      points) were administered on at least three occasions including pre-treatment (i.e.,&#xD;
      eligibility or baseline), post-treatment, and 6-month follow-up. Rating scales were completed&#xD;
      online using REDCap (Harris et al., 2009) with the exception of the School Functioning Scale.&#xD;
&#xD;
      Participants randomized to the treatment group met with their coaches individually for&#xD;
      approximately 15-20 minutes twice per week throughout the academic year, typically during&#xD;
      lunch, study hall, or an elective class. Individual sessions included study skills,&#xD;
      organization, problem solving, and interpersonal skills training. Ten, 90-minute group&#xD;
      sessions were offered to adolescents and parents in the evenings and ran concurrently. The&#xD;
      organization intervention occurred during each individual session. During initial sessions,&#xD;
      students and coaches worked collaboratively to develop a system of organizing the student's&#xD;
      binders or folders and tracking assignments in a daily planner or electronic calendar.&#xD;
      Subsequent sessions included a binder and daily planner check in which the student's&#xD;
      adherence to the system was recorded and then the student practiced addressing&#xD;
      disorganization (e.g., put assignments in the correct folders, update planner). After meeting&#xD;
      objective criteria for organization (e.g., at least 80% planner completion for two&#xD;
      consecutive weeks), adolescents independently completed organization and planner checks under&#xD;
      supervision by coaches.&#xD;
&#xD;
      Each month, coaches checked with students and school records regarding six areas of risk&#xD;
      including tardiness, absenteeism, in-school disciplinary actions, out-of-school suspension,&#xD;
      failing classes, and missing assignments. If students met a predetermined threshold for risk&#xD;
      (e.g., 80% or fewer assignments turned in on time), then the student and coach had a&#xD;
      problem-solving discussion. The goal was to both develop a solution to the relevant problem&#xD;
      as well as teach students how to use problem-solving skills. The process included (1)&#xD;
      defining the problem, (2) setting a goal, (3) brainstorming ways to achieve that goal, (4)&#xD;
      selecting one or more of these solutions, (5) determining how to know if the plan is working,&#xD;
      (6) setting a date to start implementation, and (7) setting a date to review the success of&#xD;
      the plan. During a subsequent session, the coach and student reviewed the results of the plan&#xD;
      relative to stated goals and determined if they should continue the plan or make changes.&#xD;
      During individual sessions, students and coaches critically reviewed social events and the&#xD;
      student's behavior in relation to goals. This was an extension of the evening sessions&#xD;
      focused on ISG and involved applying the skills learned in the group meetings to individual&#xD;
      social events in the participants' daily lives. For students who were not performing well on&#xD;
      tests and quizzes, coaches provided study skills intervention. Coaches reviewed test-taking&#xD;
      strategies regarding different styles of test questions (e.g., planning an outline for an&#xD;
      essay question). Students were tested on these strategies to demonstrate mastery and then&#xD;
      practice the skills on practice tests. Students also learned strategies for using flashcards&#xD;
      and class notes effectively to prepare for tests. In the ten evening sessions offered for&#xD;
      students the adolescents participated in an interpersonal skills group (ISG) to improve&#xD;
      social skills. During the first group, students were introduced to the concepts of ideal self&#xD;
      - how they want to be seen, and real self - how they really are seen. Students developed&#xD;
      ideal self goals and practiced behaving in ways that aligned with these goals during games&#xD;
      and activities and frequently reviewed progess with staff. Parents were offered 10 evening&#xD;
      sessions concurrent with students' ISG. Program staff provided psychoeducation about ADHD and&#xD;
      common difficulties faced by teenagers, including sleep hygiene. Parents also worked with&#xD;
      project staff to develop a homework management plan that determined when students would&#xD;
      complete homework each night and for how long.&#xD;
&#xD;
      Participants who were randomized to the CC condition were given a list of available resources&#xD;
      in their community and received no services from research staff. Participants in both CC and&#xD;
      the treatment condition were informed that they could receive any community services during&#xD;
      the duration of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADHD symptoms</measure>
    <time_frame>Change from Baseline ADHD symptoms through study completion, an average of 9 months.</time_frame>
    <description>Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADHD symptoms</measure>
    <time_frame>Change from Baseline ADHD symptoms through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Skills</measure>
    <time_frame>Change from Baseline social skills through study completion, an average of 9 months.</time_frame>
    <description>Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Skills</measure>
    <time_frame>Change from Baseline social skills through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grade Point Average</measure>
    <time_frame>Change from Baseline grade point average through study completion, an average of 9 months</time_frame>
    <description>Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grade Point Average</measure>
    <time_frame>Change from Baseline grade point average through six months post treatment, an average of 15 months.</time_frame>
    <description>Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Organization Skills</measure>
    <time_frame>Change from Baseline organization skills through study completion, an average of 9 months.</time_frame>
    <description>Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Organization Skills</measure>
    <time_frame>Change from Baseline organization skills through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Homework Completion</measure>
    <time_frame>Change from Baseline Homework Completion through study completion, an average of 9 months.</time_frame>
    <description>Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Homework Completion</measure>
    <time_frame>Change from Baseline Homework Completion through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Classroom Behavior and Academic Performance</measure>
    <time_frame>Change from Baseline classroom behavior and academic performance through study completion, an average of 9 months.</time_frame>
    <description>Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Classroom Behavior and Academic Performance</measure>
    <time_frame>Change from Baseline classroom behavior and academic performance through six months post treatment, an average of 15 months.</time_frame>
    <description>Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotion Regulation</measure>
    <time_frame>Change from Baseline emotion regulation through study completion, an average of 9 months.</time_frame>
    <description>Student ratings on the Difficulties with Emotion Regulation Scale;This is a 36-item scale with scores ranging from 0 to 180 and high scores representing more dysregulation of emotion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion Regulation</measure>
    <time_frame>Change from Baseline emotion regulation through six months post treatment, an average of 15 months.</time_frame>
    <description>Student ratings on the Difficulties with Emotion Regulation Scale;This is a 36-item scale with scores ranging from 0 to 180 and high scores representing more dysregulation of emotion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from Baseline anxiety through study completion, an average of 9 months.</time_frame>
    <description>Student ratings on the Beck Youth Inventory II;This is a 20-item scale ranging from 0 to 80 with high scores representing more anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from Baseline anxiety through six months post treatment, an average of 15 months.</time_frame>
    <description>Student ratings on the Beck Youth Inventory II;This is a 20-item scale ranging from 0 to 80 with high scores representing more anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from Baseline depression through study completion, an average of 9 months.</time_frame>
    <description>Student ratings on the Reynold's Adolescent Depression Scale 2 - Short Form:This is a 10-item measure with item scores ranging from 1 to 4 (total range 10 to 40) and higher scores indicate greater depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from Baseline depression through six months post treatment, an average of 15 months.</time_frame>
    <description>Student ratings on the Reynold's Adolescent Depression Scale 2 - Short Form;This is a 10-item measure with item scores ranging from 1 to 4 (total range 10 to 40) and higher scores indicate greater depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School Performance</measure>
    <time_frame>Change from Baseline school performance through study completion, an average of 9 months.</time_frame>
    <description>Parent ratings on the Adolescent Academic Problems Checklist;This is a 24-item checklist with scores ranging from 0 to 72 and high scores indicating greater problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School Performance</measure>
    <time_frame>Change from Baseline school performance through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings on the Adolescent Academic Problems Checklist;This is a 24-item checklist with scores ranging from 0 to 72 and high scores indicating greater problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of conduct disorder and oppositional defiant disorder</measure>
    <time_frame>Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through study completion, an average of 9 months.</time_frame>
    <description>Parent ratings on the Disruptive Behavior Disorders checklist;This is a 23-item scale with scores ranging from 0 to 69 with high scores indicating a higher level of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of conduct disorder and oppositional defiant disorder</measure>
    <time_frame>Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings on the Disruptive Behavior Disorders checklist;This is a 23-item scale with scores ranging from 0 to 69 with high scores indicating a higher level of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family relationships</measure>
    <time_frame>Change from Baseline family relationships through study completion, an average of 9 months.</time_frame>
    <description>Parent ratings on the Index of Family Relations;This is a 25-item scale with scores ranging from 0 to 150 with high scores indicating greater family distress in relationships.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family relationships</measure>
    <time_frame>Change from Baseline family relationships through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings on the Index of Family Relations;This is a 25-item scale with scores ranging from 0 to 150 with high scores indicating greater family distress in relationships.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent stress</measure>
    <time_frame>Change from Baseline parent stress through study completion, an average of 9 months</time_frame>
    <description>Parent ratings on the Stress Index for Parents of Adolescents;This is a 112-item scale and we used the 40-item Adolescent Domain subscale and the 32-item Adolescent-Parent Relationship Domain scale. Scores on the Adolescent Domain subscale ranged from 40 to 200 and scores on the Adolescent-Parent Relationship Domain scale ranged from 32 to 160 with high scores on each scale reflecting greater parent stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent stress</measure>
    <time_frame>Change from Baseline parent stress through six months post treatment, an average of 15 months.</time_frame>
    <description>Parent ratings on the Stress Index for Parents of Adolescents;This is a 112-item scale and we used the 40-item Adolescent Domain subscale and the 32-item Adolescent-Parent Relationship Domain scale. Scores on the Adolescent Domain subscale ranged from 40 to 200 and scores on the Adolescent-Parent Relationship Domain scale ranged from 32 to 160 with high scores on each scale reflecting greater parent stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic Achievement</measure>
    <time_frame>Change from Baseline academic achievement through study completion, an average of 9 months.</time_frame>
    <description>Adolescent's performance on the Woodcock Johnson Tests of Achievement;This is a comprehensive performance measure of achievement with standard scores with a mean of 100 and higher scores indicating higher levels of achievement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic Achievement</measure>
    <time_frame>Change from Baseline academic achievement through six months post treatment, an average of 15 months.</time_frame>
    <description>Adolescent's performance on the Woodcock Johnson Tests of Achievement;This is a comprehensive performance measure of achievement with standard scores with a mean of 100 and higher scores indicating higher levels of achievement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>CHP treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this arm received the treatment described in another section.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomly assigned to this condition received information about service providers in the community, but no services from the investigators.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Challenging Horizons Program</intervention_name>
    <description>Intervention delivered in high schools provided by school mental health professional over the course of an academic year with twice-weekly meetings with students and 10 evening group meetings with students and 10 group sessions with parents.</description>
    <arm_group_label>CHP treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  On phone screen with parent report a previous diagnosis of ADHD or elevated levels on&#xD;
             at least 4 of 9 ADHD symptoms of inattention&#xD;
&#xD;
          -  Meet diagnostic criteria for ADHD on structured diagnostic interview with parents or&#xD;
             parent and teacher ratings of symptoms and impairment&#xD;
&#xD;
          -  Demonstrate an IQ of 75 or greater on the Wechsler Abbreviated Scale of Intelligence -&#xD;
             Second Edition&#xD;
&#xD;
          -  Attend a participating high school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not exceed critical threshold on adolescent self report of substance us on the&#xD;
             Substance Abuse Subtle Screening Inventory&#xD;
&#xD;
          -  Does not meet diagnostic criteria for bipolar disorder, psychosis, or&#xD;
             obsessive-compulsive disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven W Evans, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio University</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh University</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dawson AE, Wymbs BT, Evans SW, DuPaul GJ. Exploring how adolescents with ADHD use and interact with technology. J Adolesc. 2019 Feb;71:119-137. doi: 10.1016/j.adolescence.2019.01.004. Epub 2019 Jan 25.</citation>
    <PMID>30690333</PMID>
  </reference>
  <reference>
    <citation>DuPaul GJ, Evans SW, Allan D, Puzino K, Xiang J, Cooper J, Owens JS. High school teacher ratings of academic, social, and behavioral difficulties: Factor structure and normative data for the School Functioning Scale. Sch Psychol. 2019 Sep;34(5):479-491. doi: 10.1037/spq0000323. Epub 2019 May 2.</citation>
    <PMID>31045408</PMID>
  </reference>
  <reference>
    <citation>Bunford N, Dawson AE, Evans SW, Ray AR, Langberg JM, Owens JS, DuPaul GJ, Allan DM. The Difficulties in Emotion Regulation Scale-Parent Report: A Psychometric Investigation Examining Adolescents With and Without ADHD. Assessment. 2020 Jul;27(5):921-940. doi: 10.1177/1073191118792307. Epub 2018 Aug 16.</citation>
    <PMID>30112924</PMID>
  </reference>
  <reference>
    <citation>Margherio SM, Capps ER, Monopoli JW, Evans SW, Hernandez-Rodriguez M, Owens JS, DuPaul GJ. Romantic Relationships and Sexual Behavior Among Adolescents With ADHD. J Atten Disord. 2021 Aug;25(10):1466-1478. doi: 10.1177/1087054720914371. Epub 2020 Apr 24.</citation>
    <PMID>32329399</PMID>
  </reference>
  <reference>
    <citation>Margherio SM, Brickner MA, Evans SW, Sarno Owens J, DuPaul GJ, Allan NP. The role of emotion regulation in alcohol use among adolescents with attention-deficit/hyperactivity disorder. Psychol Addict Behav. 2020 Nov;34(7):772-782. doi: 10.1037/adb0000582. Epub 2020 Apr 9.</citation>
    <PMID>32271054</PMID>
  </reference>
  <reference>
    <citation>Monopoli WJ, Evans SW, Benson K, Allan NP, Owens JS, DuPaul GJ, Bunford N. Assessment of a conceptually informed measure of emotion dysregulation: Evidence of construct validity vis a vis impulsivity and internalizing symptoms in adolescents with ADHD. Int J Methods Psychiatr Res. 2020 Dec;29(4):1-14. doi: 10.1002/mpr.1826. Epub 2020 Sep 8. Erratum In: Int J Methods Psychiatr Res. 2021 Jun;30(2):e1869.</citation>
    <PMID>32898309</PMID>
  </reference>
  <reference>
    <citation>Cleminshaw CL, DuPaul GJ, Kipperman KL, Evans SW, Owens JS. Social deficits in high school students with attention-deficit/hyperactivity disorder and the role of emotion dysregulation. Sch Psychol. 2020 Jul;35(4):233-242. doi: 10.1037/spq0000392.</citation>
    <PMID>32673052</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio University</investigator_affiliation>
    <investigator_full_name>Steven Evans</investigator_full_name>
    <investigator_title>Distinguished Professor of Psychology</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_description>IPD will be available after the main outcome studies are published. The Co-PIs will consider requests in relation to potential overlap with investigator team planned manuscripts and qualifications of person making the request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available after main outcome studies are published.</ipd_time_frame>
    <ipd_access_criteria>Contact either of the Co-PIs (Evans &amp; DuPaul)</ipd_access_criteria>
  </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/NCT04480346
org study id: R305A140356 - 15
nct id: NCT04480346
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We evaluated the extent to which receiving the school-based multi-component treatment of the
      Challenging Horizons Program (CHP) would lead to significant improvements in levels of
      symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic
      functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200
      high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to
      either CHP or a Community Care condition within each of 12 participating high schools.
      Outcome measures included parent, teacher and adolescent reports as well as observational
      data. Measures were collected at initial evaluations which preceded the one academic year of
      treatment, during the treatment period, and at six-months after treatment ended. Based on
      previous research with this treatment in middle and high schools, we anticipated meaningful
      gains for those in the treatment condition at post-treatment and larger gains on some
      variables at the 6-month follow-up evaluation.
We evaluated the extent to which receiving the school-based multi-component treatment of the
      Challenging Horizons Program (CHP) would lead to significant improvements in levels of
      symptoms of attention deficit hyperactivity disorder (ADHD) and social and academic
      functioning for high school aged adolescents diagnosed with ADHD. We intended to recruit 200
      high school aged adolescents with a diagnosis of ADHD who would be randomly assigned to
      either CHP or a Community Care condition within each of 12 participating high schools.
      Outcome measures included parent, teacher and adolescent reports as well as observational
      data. Measures were collected at initial evaluations which preceded the one academic year of
      treatment, during the treatment period, and at six-months after treatment ended. Based on
      previous research with this treatment in middle and high schools, we anticipated meaningful
      gains for those in the treatment condition at post-treatment and larger gains on some
      variables at the 6-month follow-up evaluation. Eligible participants were stratified for
      medication status and sex following the completion of all eligibility assessments for each of
      3 cohorts and were randomly assigned (within schools) to either the CHP or CC condition.
      Siblings were assigned together such that they would be in the same condition. All measures
      (except the achievement test which was given at eligibility and post-treatment assessment
      points) were administered on at least three occasions including pre-treatment (i.e.,
      eligibility or baseline), post-treatment, and 6-month follow-up. Rating scales were completed
      online using REDCap (Harris et al., 2009) with the exception of the School Functioning Scale.

      Participants randomized to the treatment group met with their coaches individually for
      approximately 15-20 minutes twice per week throughout the academic year, typically during
      lunch, study hall, or an elective class. Individual sessions included study skills,
      organization, problem solving, and interpersonal skills training. Ten, 90-minute group
      sessions were offered to adolescents and parents in the evenings and ran concurrently. The
      organization intervention occurred during each individual session. During initial sessions,
      students and coaches worked collaboratively to develop a system of organizing the student's
      binders or folders and tracking assignments in a daily planner or electronic calendar.
      Subsequent sessions included a binder and daily planner check in which the student's
      adherence to the system was recorded and then the student practiced addressing
      disorganization (e.g., put assignments in the correct folders, update planner). After meeting
      objective criteria for organization (e.g., at least 80% planner completion for two
      consecutive weeks), adolescents independently completed organization and planner checks under
      supervision by coaches.

      Each month, coaches checked with students and school records regarding six areas of risk
      including tardiness, absenteeism, in-school disciplinary actions, out-of-school suspension,
      failing classes, and missing assignments. If students met a predetermined threshold for risk
      (e.g., 80% or fewer assignments turned in on time), then the student and coach had a
      problem-solving discussion. The goal was to both develop a solution to the relevant problem
      as well as teach students how to use problem-solving skills. The process included (1)
      defining the problem, (2) setting a goal, (3) brainstorming ways to achieve that goal, (4)
      selecting one or more of these solutions, (5) determining how to know if the plan is working,
      (6) setting a date to start implementation, and (7) setting a date to review the success of
      the plan. During a subsequent session, the coach and student reviewed the results of the plan
      relative to stated goals and determined if they should continue the plan or make changes.
      During individual sessions, students and coaches critically reviewed social events and the
      student's behavior in relation to goals. This was an extension of the evening sessions
      focused on ISG and involved applying the skills learned in the group meetings to individual
      social events in the participants' daily lives. For students who were not performing well on
      tests and quizzes, coaches provided study skills intervention. Coaches reviewed test-taking
      strategies regarding different styles of test questions (e.g., planning an outline for an
      essay question). Students were tested on these strategies to demonstrate mastery and then
      practice the skills on practice tests. Students also learned strategies for using flashcards
      and class notes effectively to prepare for tests. In the ten evening sessions offered for
      students the adolescents participated in an interpersonal skills group (ISG) to improve
      social skills. During the first group, students were introduced to the concepts of ideal self
      - how they want to be seen, and real self - how they really are seen. Students developed
      ideal self goals and practiced behaving in ways that aligned with these goals during games
      and activities and frequently reviewed progess with staff. Parents were offered 10 evening
      sessions concurrent with students' ISG. Program staff provided psychoeducation about ADHD and
      common difficulties faced by teenagers, including sleep hygiene. Parents also worked with
      project staff to develop a homework management plan that determined when students would
      complete homework each night and for how long.

      Participants who were randomized to the CC condition were given a list of available resources
      in their community and received no services from research staff. Participants in both CC and
      the treatment condition were informed that they could receive any community services during
      the duration of the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ADHD symptoms
time frame: Change from Baseline ADHD symptoms through study completion, an average of 9 months.
description: Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.
measure: ADHD symptoms
time frame: Change from Baseline ADHD symptoms through six months post treatment, an average of 15 months.
description: Parent ratings of 18 DSM symptoms of ADHD;The scores range from 0 to 54 with high scores representing worse symptoms.
measure: Social Skills
time frame: Change from Baseline social skills through study completion, an average of 9 months.
description: Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).
measure: Social Skills
time frame: Change from Baseline social skills through six months post treatment, an average of 15 months.
description: Parent ratings on Social Skills Improvement System Rating Scale - parent rating version;There are 46 items on the social skills factor that are rated from 0 to 3 (range 0 to 138) with higher scores indicating better social skills. Scores are converted to age and sex based standard scores (M=100).
measure: Grade Point Average
time frame: Change from Baseline grade point average through study completion, an average of 9 months
description: Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.
measure: Grade Point Average
time frame: Change from Baseline grade point average through six months post treatment, an average of 15 months.
description: Average of grades assigned by school each grading period;Average calculated based on a 0 to 4 scale with higher GPA corresponding to higher grades.
measure: Organization Skills
time frame: Change from Baseline organization skills through study completion, an average of 9 months.
description: Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.
measure: Organization Skills
time frame: Change from Baseline organization skills through six months post treatment, an average of 15 months.
description: Parent ratings on the Children's Organization Skills Scale;This is a 66-item rating scale with three subscales including Task Planning (raw scores range from 6 to 24), Organizing Actions (raw scores range from 10 to 40), and Memory and Materials Management (raw scores range from 10 to 40). High scores indicate worse organization skills.
measure: Homework Completion
time frame: Change from Baseline Homework Completion through study completion, an average of 9 months.
description: Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.
measure: Homework Completion
time frame: Change from Baseline Homework Completion through six months post treatment, an average of 15 months.
description: Parent ratings on the Homework Problems Checklist;This is a 20 item scale with scores ranging from 0 to 60 and high scores indicate greater problems completing homework.
measure: Classroom Behavior and Academic Performance
time frame: Change from Baseline classroom behavior and academic performance through study completion, an average of 9 months.
description: Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.
measure: Classroom Behavior and Academic Performance
time frame: Change from Baseline classroom behavior and academic performance through six months post treatment, an average of 15 months.
description: Teacher ratings on the School Functioning Scale;This is a 9-item scale designed to measure behavior and academic performance in secondary school classrooms with scores ranging from 9 to 47. One 4-item factor focuses on classroom engagement behaviors and performance on tests and quizzes and scores range from 4 to 20 with high scores indicating better performance. Three questions about disruptive behavior have a range of scores from 3 to 15 with high scores indicating more disruption. Two questions focusing on interpersonal relationships produce scores ranging from 2 to 12 with high scores indicating better relationships.
measure: Emotion Regulation
time frame: Change from Baseline emotion regulation through study completion, an average of 9 months.
description: Student ratings on the Difficulties with Emotion Regulation Scale;This is a 36-item scale with scores ranging from 0 to 180 and high scores representing more dysregulation of emotion.
measure: Emotion Regulation
time frame: Change from Baseline emotion regulation through six months post treatment, an average of 15 months.
description: Student ratings on the Difficulties with Emotion Regulation Scale;This is a 36-item scale with scores ranging from 0 to 180 and high scores representing more dysregulation of emotion.
measure: Anxiety
time frame: Change from Baseline anxiety through study completion, an average of 9 months.
description: Student ratings on the Beck Youth Inventory II;This is a 20-item scale ranging from 0 to 80 with high scores representing more anxiety.
measure: Anxiety
time frame: Change from Baseline anxiety through six months post treatment, an average of 15 months.
description: Student ratings on the Beck Youth Inventory II;This is a 20-item scale ranging from 0 to 80 with high scores representing more anxiety.
measure: Depression
time frame: Change from Baseline depression through study completion, an average of 9 months.
description: Student ratings on the Reynold's Adolescent Depression Scale 2 - Short Form:This is a 10-item measure with item scores ranging from 1 to 4 (total range 10 to 40) and higher scores indicate greater depression.
measure: Depression
time frame: Change from Baseline depression through six months post treatment, an average of 15 months.
description: Student ratings on the Reynold's Adolescent Depression Scale 2 - Short Form;This is a 10-item measure with item scores ranging from 1 to 4 (total range 10 to 40) and higher scores indicate greater depression.
measure: School Performance
time frame: Change from Baseline school performance through study completion, an average of 9 months.
description: Parent ratings on the Adolescent Academic Problems Checklist;This is a 24-item checklist with scores ranging from 0 to 72 and high scores indicating greater problems.
measure: School Performance
time frame: Change from Baseline school performance through six months post treatment, an average of 15 months.
description: Parent ratings on the Adolescent Academic Problems Checklist;This is a 24-item checklist with scores ranging from 0 to 72 and high scores indicating greater problems.
measure: Symptoms of conduct disorder and oppositional defiant disorder
time frame: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through study completion, an average of 9 months.
description: Parent ratings on the Disruptive Behavior Disorders checklist;This is a 23-item scale with scores ranging from 0 to 69 with high scores indicating a higher level of symptoms.
measure: Symptoms of conduct disorder and oppositional defiant disorder
time frame: Change from Baseline symptoms of conduct disorder and oppositional defiant disorder through six months post treatment, an average of 15 months.
description: Parent ratings on the Disruptive Behavior Disorders checklist;This is a 23-item scale with scores ranging from 0 to 69 with high scores indicating a higher level of symptoms.
measure: Family relationships
time frame: Change from Baseline family relationships through study completion, an average of 9 months.
description: Parent ratings on the Index of Family Relations;This is a 25-item scale with scores ranging from 0 to 150 with high scores indicating greater family distress in relationships.
measure: Family relationships
time frame: Change from Baseline family relationships through six months post treatment, an average of 15 months.
description: Parent ratings on the Index of Family Relations;This is a 25-item scale with scores ranging from 0 to 150 with high scores indicating greater family distress in relationships.
measure: Parent stress
time frame: Change from Baseline parent stress through study completion, an average of 9 months
description: Parent ratings on the Stress Index for Parents of Adolescents;This is a 112-item scale and we used the 40-item Adolescent Domain subscale and the 32-item Adolescent-Parent Relationship Domain scale. Scores on the Adolescent Domain subscale ranged from 40 to 200 and scores on the Adolescent-Parent Relationship Domain scale ranged from 32 to 160 with high scores on each scale reflecting greater parent stress.
measure: Parent stress
time frame: Change from Baseline parent stress through six months post treatment, an average of 15 months.
description: Parent ratings on the Stress Index for Parents of Adolescents;This is a 112-item scale and we used the 40-item Adolescent Domain subscale and the 32-item Adolescent-Parent Relationship Domain scale. Scores on the Adolescent Domain subscale ranged from 40 to 200 and scores on the Adolescent-Parent Relationship Domain scale ranged from 32 to 160 with high scores on each scale reflecting greater parent stress.
measure: Academic Achievement
time frame: Change from Baseline academic achievement through study completion, an average of 9 months.
description: Adolescent's performance on the Woodcock Johnson Tests of Achievement;This is a comprehensive performance measure of achievement with standard scores with a mean of 100 and higher scores indicating higher levels of achievement.
measure: Academic Achievement
time frame: Change from Baseline academic achievement through six months post treatment, an average of 15 months.
description: Adolescent's performance on the Woodcock Johnson Tests of Achievement;This is a comprehensive performance measure of achievement with standard scores with a mean of 100 and higher scores indicating higher levels of achievement.
arm group label: CHP treatment
arm group type: Experimental
description: Participants assigned to this arm received the treatment described in another section.
arm group label: Community Care
arm group type: No Intervention
description: Participants randomly assigned to this condition received information about service providers in the community, but no services from the investigators.
intervention type: Behavioral
intervention name: Challenging Horizons Program
description: Intervention delivered in high schools provided by school mental health professional over the course of an academic year with twice-weekly meetings with students and 10 evening group meetings with students and 10 group sessions with parents.
arm group label: CHP treatment
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: No
last name: Steven W Evans, Ph.D.
role: Principal Investigator
affiliation: Ohio University
facility: 
facility: 
country: United States
citation: Dawson AE, Wymbs BT, Evans SW, DuPaul GJ. Exploring how adolescents with ADHD use and interact with technology. J Adolesc. 2019 Feb;71:119-137. doi: 10.1016/j.adolescence.2019.01.004. Epub 2019 Jan 25.
PMID: 30690333
citation: DuPaul GJ, Evans SW, Allan D, Puzino K, Xiang J, Cooper J, Owens JS. High school teacher ratings of academic, social, and behavioral difficulties: Factor structure and normative data for the School Functioning Scale. Sch Psychol. 2019 Sep;34(5):479-491. doi: 10.1037/spq0000323. Epub 2019 May 2.
PMID: 31045408
citation: Bunford N, Dawson AE, Evans SW, Ray AR, Langberg JM, Owens JS, DuPaul GJ, Allan DM. The Difficulties in Emotion Regulation Scale-Parent Report: A Psychometric Investigation Examining Adolescents With and Without ADHD. Assessment. 2020 Jul;27(5):921-940. doi: 10.1177/1073191118792307. Epub 2018 Aug 16.
PMID: 30112924
citation: Margherio SM, Capps ER, Monopoli JW, Evans SW, Hernandez-Rodriguez M, Owens JS, DuPaul GJ. Romantic Relationships and Sexual Behavior Among Adolescents With ADHD. J Atten Disord. 2021 Aug;25(10):1466-1478. doi: 10.1177/1087054720914371. Epub 2020 Apr 24.
PMID: 32329399
citation: Margherio SM, Brickner MA, Evans SW, Sarno Owens J, DuPaul GJ, Allan NP. The role of emotion regulation in alcohol use among adolescents with attention-deficit/hyperactivity disorder. Psychol Addict Behav. 2020 Nov;34(7):772-782. doi: 10.1037/adb0000582. Epub 2020 Apr 9.
PMID: 32271054
citation: Monopoli WJ, Evans SW, Benson K, Allan NP, Owens JS, DuPaul GJ, Bunford N. Assessment of a conceptually informed measure of emotion dysregulation: Evidence of construct validity vis a vis impulsivity and internalizing symptoms in adolescents with ADHD. Int J Methods Psychiatr Res. 2020 Dec;29(4):1-14. doi: 10.1002/mpr.1826. Epub 2020 Sep 8. Erratum In: Int J Methods Psychiatr Res. 2021 Jun;30(2):e1869.
PMID: 32898309
citation: Cleminshaw CL, DuPaul GJ, Kipperman KL, Evans SW, Owens JS. Social deficits in high school students with attention-deficit/hyperactivity disorder and the role of emotion dysregulation. Sch Psychol. 2020 Jul;35(4):233-242. doi: 10.1037/spq0000392.
PMID: 32673052
responsible party type: Principal Investigator
investigator affiliation: Ohio University
investigator full name: Steven Evans
investigator title: Distinguished Professor of Psychology
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: Yes
ipd description: IPD will be available after the main outcome studies are published. The Co-PIs will consider requests in relation to potential overlap with investigator team planned manuscripts and qualifications of person making the request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available after main outcome studies are published.
ipd access criteria: Contact either of the Co-PIs (Evans & DuPaul)