<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/NCT01686724</url>
  </required_header>
  <id_info>
    <org_study_id>R324A120358</org_study_id>
    <nct_id>NCT01686724</nct_id>
  </id_info>
  <brief_title>Study of the Collaborative Life Skills Program</brief_title>
  <official_title>Efficacy of the Collaborative Life Skills Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests the effectiveness of a newly developed integrated school-home behavioral&#xD;
      intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The&#xD;
      intervention is implemented by school-based mental health professionals within school&#xD;
      settings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.</measure>
    <time_frame>change from baseline on ADHD symptoms at 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Homework Problems Checklist (HPC)</measure>
    <time_frame>change from baseline in homework problems at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic Competency Evaluation Scale (ACES)</measure>
    <time_frame>change from baseline in ACES at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homework Problems Checklist (HPC)</measure>
    <time_frame>change from baseline in homework problems at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic Competency Evaluation Scale (ACES)</measure>
    <time_frame>change from baseline in ACES at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Organizational Skills Scale (COSS)</measure>
    <time_frame>change from baseline in COSS at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Organizational Skills Scale (COSS)</measure>
    <time_frame>change from baseline in COSS at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observations of classroom/school behavior</measure>
    <time_frame>change from baseline on observed on-task behavior at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observations of classroom/school behavior</measure>
    <time_frame>change from baseline in observed on-task behavior at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic achievement</measure>
    <time_frame>change from baseline in academic achievement at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic Achievement</measure>
    <time_frame>change from baseline in academic achievement at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Skills Improvement Scale</measure>
    <time_frame>change from baseline in social/behavioral functioning at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Skills Improvement Scale</measure>
    <time_frame>change from baseline in social/behavioral functioning at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test of Life Skills Knowledge</measure>
    <time_frame>change from baseline in life skills knowledge at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test of Life Skills Knowledge</measure>
    <time_frame>change from baseline in life skills knowledge at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alabama Parenting Questionnaire</measure>
    <time_frame>change from baseline in parenting practices at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alabama Parenting Questionnaire</measure>
    <time_frame>change from baseline in parenting practices at 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Stress Index</measure>
    <time_frame>change from baseline in parenting stress at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Stress Index</measure>
    <time_frame>change from baseline in parenting stress at 7 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">504</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder Symptoms</condition>
  <arm_group>
    <arm_group_label>Business as Usual (BAU)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collaborative Life Skills Intervention (CLS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Collaborative Life Skills Intervention (CLS)</intervention_name>
    <description>CLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.</description>
    <arm_group_label>Collaborative Life Skills Intervention (CLS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Business As Usual</intervention_name>
    <arm_group_label>Business as Usual (BAU)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Attending a participating school and in 2-5th grade&#xD;
&#xD;
          -  Referral by LSP as a child with apparent ADHD-related problems&#xD;
&#xD;
          -  ≥ 6 symptoms (item score ≥ 2) of Inattention or Hyperactivity-Impulsivity on the&#xD;
             pooled parent and teacher Child Symptom Inventory&#xD;
&#xD;
          -  ≥ 3 on the Impairment Rating Scale by parent and teacher (cross-situational&#xD;
             impairment)&#xD;
&#xD;
          -  FSIQ or VIQ ≥ 80 (necessary for cognitive demands of the child skills curriculum)&#xD;
&#xD;
          -  Caretaker consents to participate in treatment, child assents to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of conditions that are incompatible with this study's treatment.&#xD;
&#xD;
          -  severe visual or hearing impairment,&#xD;
&#xD;
          -  severe language delay,&#xD;
&#xD;
          -  psychosis,&#xD;
&#xD;
          -  pervasive developmental disorder&#xD;
&#xD;
          -  Parent or child does not read or speak English or does not read or speak Spanish for&#xD;
             our Spanish language implementation of CLS (inability to complete assessment measures&#xD;
             or participate in group treatments).&#xD;
&#xD;
          -  Child is in an all-day special education classroom (children in these classrooms are&#xD;
             frequently receiving intensive behavior modification programs such that the&#xD;
             intervention would be expected to require modification for use in these settings)&#xD;
&#xD;
          -  Children taking psychotropic medication for any reason other than to treat ADHD&#xD;
&#xD;
          -  Children planning to change (start or stop) psychotropic medication&#xD;
&#xD;
          -  Children who have changed a regimen of psychotropic medication (started or stopped)&#xD;
             within 30 days prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Pfiffner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attention Deficit Hyperactivity Disorder</keyword>
  <keyword>Psychosocial Intervention</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>School-home collaborative intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01686724
org study id: R324A120358
nct id: NCT01686724
lead sponsor: 
has dmc: No
This study tests the effectiveness of a newly developed integrated school-home behavioral
      intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The
      intervention is implemented by school-based mental health professionals within school
      settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.
time frame: change from baseline on ADHD symptoms at 12 weeks
measure: Homework Problems Checklist (HPC)
time frame: change from baseline in homework problems at 12 weeks
measure: Academic Competency Evaluation Scale (ACES)
time frame: change from baseline in ACES at 12 weeks
measure: Homework Problems Checklist (HPC)
time frame: change from baseline in homework problems at 7 months
measure: Academic Competency Evaluation Scale (ACES)
time frame: change from baseline in ACES at 7 months
measure: Children's Organizational Skills Scale (COSS)
time frame: change from baseline in COSS at 12 weeks
measure: Children's Organizational Skills Scale (COSS)
time frame: change from baseline in COSS at 7 months
measure: Observations of classroom/school behavior
time frame: change from baseline on observed on-task behavior at 12 weeks
measure: Observations of classroom/school behavior
time frame: change from baseline in observed on-task behavior at 7 months
measure: Academic achievement
time frame: change from baseline in academic achievement at 12 weeks
measure: Academic Achievement
time frame: change from baseline in academic achievement at 7 months
measure: Social Skills Improvement Scale
time frame: change from baseline in social/behavioral functioning at 12 weeks
measure: Social Skills Improvement Scale
time frame: change from baseline in social/behavioral functioning at 7 months
measure: Test of Life Skills Knowledge
time frame: change from baseline in life skills knowledge at 12 weeks
measure: Test of Life Skills Knowledge
time frame: change from baseline in life skills knowledge at 7 months
measure: Alabama Parenting Questionnaire
time frame: change from baseline in parenting practices at 12 weeks
measure: Alabama Parenting Questionnaire
time frame: change from baseline in parenting practices at 7 months
measure: Parenting Stress Index
time frame: change from baseline in parenting stress at 12 weeks
measure: Parenting Stress Index
time frame: change from baseline in parenting stress at 7 months
arm group label: Business as Usual (BAU)
arm group type: Other
description: This group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered.
arm group label: Collaborative Life Skills Intervention (CLS)
arm group type: Experimental
description: CLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.
intervention type: Behavioral
intervention name: Collaborative Life Skills Intervention (CLS)
description: CLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.
arm group label: Collaborative Life Skills Intervention (CLS)
intervention type: Other
intervention name: Business As Usual
arm group label: Business as Usual (BAU)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 11 Years
healthy volunteers: No
last name: Linda Pfiffner, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity