<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/NCT02981849</url>
  </required_header>
  <id_info>
    <org_study_id>P00019608</org_study_id>
    <nct_id>NCT02981849</nct_id>
  </id_info>
  <brief_title>Validating Adolescent SBIRT Measures</brief_title>
  <official_title>Validating Adolescent SBIRT Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conrad N. Hilton Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to address the needs for efficient and informative measurement&#xD;
      for evaluating adolescent Screening, Brief Intervention, and Referral to Treatment (SBIRT)&#xD;
      strategies. The investigators will undertake a longitudinal cohort study to build and&#xD;
      validate a substance specific measurement battery that includes patient-centered and&#xD;
      intermediary outcomes which can be integrated into a range of healthcare and research&#xD;
      settings. The results of this project will enable evaluation of SBIRT trials and clinical&#xD;
      efforts by validating a parsimonious set of measurement tools that can be incorporated into&#xD;
      electronic health records. The primary goal of the proposed project is to develop a set of&#xD;
      brief, valid tools that will allow both researchers and clinicians to collect information&#xD;
      that enables evaluating and refining brief interventions.&#xD;
&#xD;
      The main objective is to define and disseminate a set of brief and easy to administer&#xD;
      measures that accurately detect 1) substance use frequency, 2) substance-specific patient&#xD;
      centered outcomes and 3) intermediate measures of impact of adolescent SBIRT. The specific&#xD;
      aim addressed in this project is to develop and administer an assessment battery that&#xD;
      includes novel questions assessing substance use to be validated against criterion standard&#xD;
      measures both cross-sectionally and longitudinally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A policy level mandate now exists to deliver screening, brief intervention, and referral to&#xD;
      treatment (SBIRT) to all adolescents in primary care. This mandate is spurred by the&#xD;
      imperative to reduce the enormous and preventable morbidity and mortality caused by&#xD;
      adolescent substance use. Despite this mandate and the opportunity to reach large cohorts of&#xD;
      youth early within primary and specialty pediatric care, SBIRT is not routinely delivered nor&#xD;
      used in ways that optimize outcomes. The National Institute on Drug Abuse, National Institute&#xD;
      on Alcoholism and Alcohol Abuse, the Substance Use and Mental Health Services Administration&#xD;
      and the Hilton Foundation have all included adolescent SBIRT in their research, training and&#xD;
      service project portfolios. Lacking validated measures that can be used to assess impacts and&#xD;
      guide early action, opportunities to glean the most effective strategies and components of&#xD;
      brief interventions are hampered despite these considerable investments. This threatens the&#xD;
      relevance and sustainability of this work.&#xD;
&#xD;
      To address the needs for efficient and informative measurement for evaluating adolescent&#xD;
      Screening, Brief Intervention, and Referral to Treatment (SBIRT) strategies, the&#xD;
      investigators will undertake a longitudinal cohort study to build and validate a substance&#xD;
      specific measurement battery that includes patient-centered and intermediary outcomes which&#xD;
      can be integrated into a range of healthcare and research settings. This is a construct&#xD;
      validity study in which the investigators will be interested in seeing whether a brief set of&#xD;
      questions will accurately measure substance use when compared to lengthy gold standard&#xD;
      measures. This is also a predictive validity study, in which the investigators are interested&#xD;
      in seeing whether proposed patient-centered and intermediary outcomes are relevant in&#xD;
      predicting future substance use risk or patterns of use. The results of this project will&#xD;
      enable evaluation of SBIRT trials and clinical efforts by validating a parsimonious set of&#xD;
      measurement tools that can be incorporated into electronic health records.&#xD;
&#xD;
      This project is one component of a two part study in which the investigators will enroll a&#xD;
      total of 900 adolescents. The investigators will enroll a total of 450 participants from the&#xD;
      Adolescent/Young Adult Medical Clinic for this study and will attempt to follow participant&#xD;
      for one year. Accounting for attrition at 6 months and 12 months follow-up, the investigators&#xD;
      expect 300 participants will complete the entire study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validation of adolescent substance use measures</measure>
    <time_frame>Past year</time_frame>
    <description>This is a validation project. We aim to validate a single question regarding the frequency of substance against the criterion standard timeline followback calendar</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictive behaviors that indicate a change in substance use frequency</measure>
    <time_frame>1 year</time_frame>
    <description>Change in substance use frequency at 1 year</description>
  </primary_outcome>
  <enrollment type="Actual">514</enrollment>
  <condition>Substance Abuse</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescent, ages 14-17, receiving care at the Adolescent/Young Adult Medicine Clinic at&#xD;
        Boston Children's Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  14-17 year-old youth presenting for routine medical care at the Adolescent and Young&#xD;
             Adult clinic at BCH, with informed assent/consent.&#xD;
&#xD;
          -  To be eligible, youth must be between 14-17 years old at the time of enrollment and be&#xD;
             able to read and understand English at a middle school level or greater.&#xD;
&#xD;
          -  Participants must consent to participation in the study and consent to the 6 month and&#xD;
             12 month follow up assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are medically or emotionally unstable or otherwise unable to&#xD;
             assent/consent at the time of their appointment as determined by their clinician or&#xD;
             the research team, those who are unable to speak/read English at a middle school&#xD;
             reading level, use a computer keyboard and/or complete an interviewer-assisted&#xD;
             questionnaire will be excluded.&#xD;
&#xD;
          -  Participants who do not consent to 6 month and 12 month re-assessment will also be&#xD;
             excluded.&#xD;
&#xD;
          -  Patients who are pregnant at baseline will be excluded from the study.&#xD;
&#xD;
          -  If a participant enrolls in the study and becomes pregnant after baseline, the&#xD;
             participant will not be excluded from the follow up assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>
  <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>January 2020</verification_date>
  <study_first_submitted>March 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</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>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</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/NCT02981849
org study id: P00019608
nct id: NCT02981849
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to address the needs for efficient and informative measurement
      for evaluating adolescent Screening, Brief Intervention, and Referral to Treatment (SBIRT)
      strategies. The investigators will undertake a longitudinal cohort study to build and
      validate a substance specific measurement battery that includes patient-centered and
      intermediary outcomes which can be integrated into a range of healthcare and research
      settings. The results of this project will enable evaluation of SBIRT trials and clinical
      efforts by validating a parsimonious set of measurement tools that can be incorporated into
      electronic health records. The primary goal of the proposed project is to develop a set of
      brief, valid tools that will allow both researchers and clinicians to collect information
      that enables evaluating and refining brief interventions.

      The main objective is to define and disseminate a set of brief and easy to administer
      measures that accurately detect 1) substance use frequency, 2) substance-specific patient
      centered outcomes and 3) intermediate measures of impact of adolescent SBIRT. The specific
      aim addressed in this project is to develop and administer an assessment battery that
      includes novel questions assessing substance use to be validated against criterion standard
      measures both cross-sectionally and longitudinally.
A policy level mandate now exists to deliver screening, brief intervention, and referral to
      treatment (SBIRT) to all adolescents in primary care. This mandate is spurred by the
      imperative to reduce the enormous and preventable morbidity and mortality caused by
      adolescent substance use. Despite this mandate and the opportunity to reach large cohorts of
      youth early within primary and specialty pediatric care, SBIRT is not routinely delivered nor
      used in ways that optimize outcomes. The National Institute on Drug Abuse, National Institute
      on Alcoholism and Alcohol Abuse, the Substance Use and Mental Health Services Administration
      and the Hilton Foundation have all included adolescent SBIRT in their research, training and
      service project portfolios. Lacking validated measures that can be used to assess impacts and
      guide early action, opportunities to glean the most effective strategies and components of
      brief interventions are hampered despite these considerable investments. This threatens the
      relevance and sustainability of this work.

      To address the needs for efficient and informative measurement for evaluating adolescent
      Screening, Brief Intervention, and Referral to Treatment (SBIRT) strategies, the
      investigators will undertake a longitudinal cohort study to build and validate a substance
      specific measurement battery that includes patient-centered and intermediary outcomes which
      can be integrated into a range of healthcare and research settings. This is a construct
      validity study in which the investigators will be interested in seeing whether a brief set of
      questions will accurately measure substance use when compared to lengthy gold standard
      measures. This is also a predictive validity study, in which the investigators are interested
      in seeing whether proposed patient-centered and intermediary outcomes are relevant in
      predicting future substance use risk or patterns of use. The results of this project will
      enable evaluation of SBIRT trials and clinical efforts by validating a parsimonious set of
      measurement tools that can be incorporated into electronic health records.

      This project is one component of a two part study in which the investigators will enroll a
      total of 900 adolescents. The investigators will enroll a total of 450 participants from the
      Adolescent/Young Adult Medical Clinic for this study and will attempt to follow participant
      for one year. Accounting for attrition at 6 months and 12 months follow-up, the investigators
      expect 300 participants will complete the entire study.
observational model: Cohort
time perspective: Cross-Sectional
measure: Validation of adolescent substance use measures
time frame: Past year
description: This is a validation project. We aim to validate a single question regarding the frequency of substance against the criterion standard timeline followback calendar
measure: Predictive behaviors that indicate a change in substance use frequency
time frame: 1 year
description: Change in substance use frequency at 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon Levy, MD, MPH
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: Associate Professor of Pediatrics
mesh term: Substance-Related Disorders
sharing ipd: No