<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/NCT01709201</url>
  </required_header>
  <id_info>
    <org_study_id>FP01009751</org_study_id>
    <nct_id>NCT01709201</nct_id>
  </id_info>
  <brief_title>Reducing Problematic Substance Use in Youth With Chronic Medical Conditions</brief_title>
  <official_title>Reducing Problematic Substance Use in Youth With Chronic Medical Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators goal is to pilot a substance use-related brief intervention (BI) for youth&#xD;
      with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability&#xD;
      and impacts of the approach for reducing substance use among this group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study did not receive funding and was administratively withdrawn.&#xD;
  </why_stopped>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent days abstinent</measure>
    <time_frame>30 days post baseline</time_frame>
    <description>We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical complications</measure>
    <time_frame>30 days post baseline</time_frame>
    <description>We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percent Days Abstinent 90 days post baseline</measure>
    <time_frame>90 days post baseline</time_frame>
    <description>We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 90 days post baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Medical complications 90 days post baseline</measure>
    <time_frame>90 days post baseline</time_frame>
    <description>We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Alcohol Abuse</condition>
  <condition>Drug Abuse</condition>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Intervention</intervention_name>
    <description>Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.</description>
    <arm_group_label>Brief Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  14-18 years old&#xD;
&#xD;
          -  Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative&#xD;
             colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at&#xD;
             least one year&#xD;
&#xD;
          -  Previous participation in the screening validation study&#xD;
&#xD;
          -  Evidence of problems related to substance use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically or emotionally unstable or otherwise unable to provide assent/consent&#xD;
&#xD;
          -  Unable to speak/read English&#xD;
&#xD;
          -  Unable to use a computer keyboard and/or complete an interviewer-assisted&#xD;
             questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Levy, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elissa Weitzman, ScD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>June 19, 2017</last_update_submitted>
  <last_update_submitted_qc>June 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Sharon Levy</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics, Harvard Medical School</investigator_title>
  </responsible_party>
  <keyword>Alcohol abuse</keyword>
  <keyword>Drug abuse</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Persistent Asthma</keyword>
  <keyword>Juvenile Arthritis</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Alcoholism</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/NCT01709201
org study id: FP01009751
nct id: NCT01709201
lead sponsor: 
has dmc: No
The investigators goal is to pilot a substance use-related brief intervention (BI) for youth
      with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability
      and impacts of the approach for reducing substance use among this group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percent days abstinent
time frame: 30 days post baseline
description: We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline
measure: Medical complications
time frame: 30 days post baseline
description: We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline
measure: Percent Days Abstinent 90 days post baseline
time frame: 90 days post baseline
description: We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 90 days post baseline
measure: Medical complications 90 days post baseline
time frame: 90 days post baseline
description: We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline
arm group label: Treatment as Usual
arm group type: No Intervention
description: Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure.
arm group label: Brief Intervention
arm group type: Experimental
description: Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use.
intervention type: Behavioral
intervention name: Brief Intervention
description: Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.
arm group label: Brief Intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: No
last name: Sharon Levy, MD, MPH
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Elissa Weitzman, ScD, MSc
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Sharon Levy
investigator title: Assistant Professor of Pediatrics, Harvard Medical School
mesh term: Substance-Related Disorders
mesh term: Alcoholism