<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/NCT04450966</url>
  </required_header>
  <id_info>
    <org_study_id>NIAAA_1R01AA027253-01A1</org_study_id>
    <nct_id>NCT04450966</nct_id>
  </id_info>
  <brief_title>Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care</brief_title>
  <acronym>ASPIRE</acronym>
  <official_title>Computer-facilitated Screening and Brief Intervention (cSBI) in Pediatric Primary Care to Reduce Underage Drinking: a Large, Multi-site Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Academy of Pediatrics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising&#xD;
      computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for&#xD;
      delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and&#xD;
      related riding/driving safety risk among adolescent patients. Our setting will be the&#xD;
      American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national&#xD;
      primary care research network, with &gt;600 U.S. primary care practices having participated in&#xD;
      recent studies. This trial addresses the evidence gap identified in the latest U.S.&#xD;
      Preventive Services Task Force review of alcohol screening and brief counseling interventions&#xD;
      among adolescents, and, if shown effective, the cSBI system could be widely disseminated via&#xD;
      AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician&#xD;
      members, thereby greatly increasing the potential for population-level impact of alcohol&#xD;
      screening and brief intervention for U.S. adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol use disorders frequently have a pediatric origin. Pediatric primary care offices,&#xD;
      where the majority of adolescents receive health care, are a promising venue for early&#xD;
      identification and intervention through universal screening and brief counseling. However,&#xD;
      while the U.S. Preventive Services Task Force recommends primary care-based alcohol screening&#xD;
      and brief intervention for adults, it found insufficient evidence to recommend it for&#xD;
      adolescents.&#xD;
&#xD;
      The goal of the proposed study is to address this evidence gap by testing the effectiveness&#xD;
      of a promising computer-facilitated Screening and Brief Intervention (cSBI) system for&#xD;
      delivery by pediatric primary care clinicians to adolescents at well-visits. This&#xD;
      cluster-randomized controlled trial will be conducted in the American Academy of Pediatrics'&#xD;
      (AAP) Pediatric Research in Office Settings (PROS) national primary care practice-based&#xD;
      research network. PROS has demonstrated success in &gt;30 years of practice-based research, with&#xD;
      &gt;600 practices participating in recent studies. Drawing on more than 15 years of our prior&#xD;
      research on adolescent alcohol screening and brief counseling in primary care offices, the&#xD;
      cSBI system was developed to provide a time-efficient and feasible way for pediatric&#xD;
      practices to improve both the frequency and quality of alcohol screening and counseling. cSBI&#xD;
      includes: 1) computer self-administered screening that adolescents complete prior to seeing&#xD;
      their clinician, 2) 10 interactive psychoeducational pages for the adolescent on substance&#xD;
      use health risks, 3) a Clinician Report Form with screen results and prompts that clinicians&#xD;
      use to provide motivational interviewing-based individualized counseling, and 4) clinician&#xD;
      training materials and protocol.&#xD;
&#xD;
      In a New England-based pilot study, we found that, compared to usual care (UC), the cSBI&#xD;
      approach: 1) increased patient receipt of alcohol-related counseling during well-visits; 2)&#xD;
      improved patients' ratings of the quality of their clinician encounter; and 3) among those&#xD;
      who reported past-year use at baseline (n=192), was associated with a 34% lower risk of a&#xD;
      heavy episodic drinking episode during 12 months follow-up. cSBI also reduced risk of riding&#xD;
      with an impaired driver, a major safety risk associated with alcohol, by 42% among those with&#xD;
      prior riding risk.&#xD;
&#xD;
      A larger RCT of this approach, which employs an adequately-powered sample and tests&#xD;
      generalizability of effects beyond New England, is needed. We will randomize &gt;30 pediatric&#xD;
      primary care clinicians in ~10 practices nationwide to deliver UC or cSBI (1:1) to their&#xD;
      eligible and assenting 14- to 17-year-old patients arriving for well-visits. Our aims are to&#xD;
      test cSBI's effect on heavy episodic drinking, and on riding with an impaired driver/driving&#xD;
      while impaired, during 12 months follow-up among 1,300 adolescents screen-identified as&#xD;
      at-risk. We hypothesize that, compared to adolescent patients receiving usual care, those&#xD;
      receiving cSBI will have lower rates of reporting heavy episodic drinking and riding with an&#xD;
      impaired driver/driving while impaired during the study follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 10, 2023</start_date>
  <completion_date type="Anticipated">October 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</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>
    <intervention_model_description>Multi-site cluster-randomized parallel groups trial. &gt;30 pediatric primary care clinicians will be recruited from ~10 practices and will be allocated 1:1 to either deliver usual care or the cSBI intervention to their participating patients ages 14-17 years-old.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any heavy episodic drinking day during past 3 months</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Defined using the NIAAA Youth Guide age/gender-specific number of drinks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any heavy episodic drinking day during past 3 months</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Defined using the NIAAA Youth Guide age/gender-specific number of drinks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any heavy episodic drinking day during past 3 months</measure>
    <time_frame>9 months follow-up</time_frame>
    <description>Defined using the NIAAA Youth Guide age/gender-specific number of drinks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any heavy episodic drinking day during past 3 months</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Defined using the NIAAA Youth Guide age/gender-specific number of drinks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Any riding/driving risk</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any riding/driving risk</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any riding/driving risk</measure>
    <time_frame>9 months follow-up</time_frame>
    <description>Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any riding/driving risk</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Alcohol-related problems or negative consequences experienced since baseline</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Score on scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Alcohol-related problems or negative consequences experienced since baseline</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Score on scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months alcohol use days</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Number of days of any alcohol use in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months alcohol use days</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Number of days of any alcohol use in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months alcohol use days</measure>
    <time_frame>9 months follow-up</time_frame>
    <description>Number of days of any alcohol use in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months alcohol use days</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Number of days of any alcohol use in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months heavy episodic drinking days</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Number of days of heavy episodic drinking in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months heavy episodic drinking days</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Number of days of heavy episodic drinking in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months heavy episodic drinking days</measure>
    <time_frame>9 months follow-up</time_frame>
    <description>Number of days of heavy episodic drinking in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Past 3 months heavy episodic drinking days</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Number of days of heavy episodic drinking in past 3 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived risk of harm</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived risk of harm</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived risk of harm</measure>
    <time_frame>9 months follow-up</time_frame>
    <description>Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived risk of harm</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking</description>
  </other_outcome>
  <other_outcome>
    <measure>Drinking refusal self-efficacy</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Score on Drinking Refusal Self-Efficacy measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Drinking refusal self-efficacy</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Score on Drinking Refusal Self-Efficacy measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Drinking refusal self-efficacy</measure>
    <time_frame>9 months follow-up</time_frame>
    <description>Score on Drinking Refusal Self-Efficacy measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Drinking refusal self-efficacy</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Score on Drinking Refusal Self-Efficacy measure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>Heavy Drinking</condition>
  <condition>Driving Under the Influence</condition>
  <condition>Riding With Driver Under the Influence</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computer-facilitated screening and brief intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer-facilitated Screening and Brief Intervention</intervention_name>
    <description>cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, immediately followed by 2) computer-delivered brief psychoeducation on the health risks of substance use to prime patients for the clinician encounter, and 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling during the visit.</description>
    <arm_group_label>Computer-facilitated screening and brief intervention</arm_group_label>
    <other_name>cSBI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 14-17&#xD;
&#xD;
          -  Presenting for well-visit with participating clinician&#xD;
&#xD;
          -  Reports any past 12 month alcohol use&#xD;
&#xD;
          -  If no past-12-month alcohol use, reports riding with a driver under the influence in&#xD;
             the past 12 months&#xD;
&#xD;
          -  Has own cell phone and is willing to share cell phone number before their scheduled&#xD;
             visit&#xD;
&#xD;
          -  Completes required pre-visit activity/activities before well visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Youth in foster care&#xD;
&#xD;
          -  Unable to read and communicate in English&#xD;
&#xD;
          -  College students at time of recruitment&#xD;
&#xD;
          -  Unable to complete follow-ups&#xD;
&#xD;
          -  Currently receiving treatment from specialty clinician(s) for a substance use concern&#xD;
&#xD;
          -  Deemed by their clinician to be inappropriate for study participation due to&#xD;
             neurodevelopmental delays or medical/emotional concerns&#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>Sion K Harris, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sion K Harris, PhD</last_name>
    <phone>857-218-4304</phone>
    <email>sion.harris@childrens.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lydia A. Shrier, MD, MPH</last_name>
    <phone>617-355-5133</phone>
    <email>lydia.shrier@childrens.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>American Academy of Pediatrics</name>
      <address>
        <city>Itasca</city>
        <state>Illinois</state>
        <zip>60143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Torres, MPH</last_name>
      <email>atorres@aap.org</email>
    </contact>
    <contact_backup>
      <last_name>Donna L Harris, MA</last_name>
      <email>dlharris@aap.org</email>
    </contact_backup>
    <investigator>
      <last_name>Alison Torres, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sion K Harris, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lydia A. Shrier, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pamela J. Burke, PhD, RN, FNP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Fiks, MD, MSCE</last_name>
      <email>fiksa@email.chop.edu</email>
    </contact>
    <investigator>
      <last_name>Alex Fiks, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard Medical School (HMS and HSDM)</investigator_affiliation>
    <investigator_full_name>Sion Kim Harris</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will provide a variable codebook along with the dataset. We will make a de-identified version of the complete and cleaned study dataset available to the AAP's PROS Study Archive at study completion, as well as NIAAA Data Archive (NIAAADA).</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_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within 12 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>We will share the dataset with external investigators when a data use agreement (DUA) is executed between Boston Children's Hospital and the institution of the person making the request. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project and schedule for data destruction.</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/NCT04450966
org study id: NIAAA_1R01AA027253-01A1
nct id: NCT04450966
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising
      computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for
      delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and
      related riding/driving safety risk among adolescent patients. Our setting will be the
      American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national
      primary care research network, with >600 U.S. primary care practices having participated in
      recent studies. This trial addresses the evidence gap identified in the latest U.S.
      Preventive Services Task Force review of alcohol screening and brief counseling interventions
      among adolescents, and, if shown effective, the cSBI system could be widely disseminated via
      AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician
      members, thereby greatly increasing the potential for population-level impact of alcohol
      screening and brief intervention for U.S. adolescents.
Alcohol use disorders frequently have a pediatric origin. Pediatric primary care offices,
      where the majority of adolescents receive health care, are a promising venue for early
      identification and intervention through universal screening and brief counseling. However,
      while the U.S. Preventive Services Task Force recommends primary care-based alcohol screening
      and brief intervention for adults, it found insufficient evidence to recommend it for
      adolescents.

      The goal of the proposed study is to address this evidence gap by testing the effectiveness
      of a promising computer-facilitated Screening and Brief Intervention (cSBI) system for
      delivery by pediatric primary care clinicians to adolescents at well-visits. This
      cluster-randomized controlled trial will be conducted in the American Academy of Pediatrics'
      (AAP) Pediatric Research in Office Settings (PROS) national primary care practice-based
      research network. PROS has demonstrated success in >30 years of practice-based research, with
      >600 practices participating in recent studies. Drawing on more than 15 years of our prior
      research on adolescent alcohol screening and brief counseling in primary care offices, the
      cSBI system was developed to provide a time-efficient and feasible way for pediatric
      practices to improve both the frequency and quality of alcohol screening and counseling. cSBI
      includes: 1) computer self-administered screening that adolescents complete prior to seeing
      their clinician, 2) 10 interactive psychoeducational pages for the adolescent on substance
      use health risks, 3) a Clinician Report Form with screen results and prompts that clinicians
      use to provide motivational interviewing-based individualized counseling, and 4) clinician
      training materials and protocol.

      In a New England-based pilot study, we found that, compared to usual care (UC), the cSBI
      approach: 1) increased patient receipt of alcohol-related counseling during well-visits; 2)
      improved patients' ratings of the quality of their clinician encounter; and 3) among those
      who reported past-year use at baseline (n=192), was associated with a 34% lower risk of a
      heavy episodic drinking episode during 12 months follow-up. cSBI also reduced risk of riding
      with an impaired driver, a major safety risk associated with alcohol, by 42% among those with
      prior riding risk.

      A larger RCT of this approach, which employs an adequately-powered sample and tests
      generalizability of effects beyond New England, is needed. We will randomize >30 pediatric
      primary care clinicians in ~10 practices nationwide to deliver UC or cSBI (1:1) to their
      eligible and assenting 14- to 17-year-old patients arriving for well-visits. Our aims are to
      test cSBI's effect on heavy episodic drinking, and on riding with an impaired driver/driving
      while impaired, during 12 months follow-up among 1,300 adolescents screen-identified as
      at-risk. We hypothesize that, compared to adolescent patients receiving usual care, those
      receiving cSBI will have lower rates of reporting heavy episodic drinking and riding with an
      impaired driver/driving while impaired during the study follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multi-site cluster-randomized parallel groups trial. >30 pediatric primary care clinicians will be recruited from ~10 practices and will be allocated 1:1 to either deliver usual care or the cSBI intervention to their participating patients ages 14-17 years-old.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Any heavy episodic drinking day during past 3 months
time frame: 3 months follow-up
description: Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
measure: Any heavy episodic drinking day during past 3 months
time frame: 6 months follow-up
description: Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
measure: Any heavy episodic drinking day during past 3 months
time frame: 9 months follow-up
description: Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
measure: Any heavy episodic drinking day during past 3 months
time frame: 12 months follow-up
description: Defined using the NIAAA Youth Guide age/gender-specific number of drinks.
measure: Any riding/driving risk
time frame: 3 months follow-up
description: Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months
measure: Any riding/driving risk
time frame: 6 months follow-up
description: Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months
measure: Any riding/driving risk
time frame: 9 months follow-up
description: Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months
measure: Any riding/driving risk
time frame: 12 months follow-up
description: Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months
measure: Alcohol-related problems or negative consequences experienced since baseline
time frame: 6 months follow-up
description: Score on scale
measure: Alcohol-related problems or negative consequences experienced since baseline
time frame: 12 months follow-up
description: Score on scale
measure: Past 3 months alcohol use days
time frame: 3 months follow-up
description: Number of days of any alcohol use in past 3 months
measure: Past 3 months alcohol use days
time frame: 6 months follow-up
description: Number of days of any alcohol use in past 3 months
measure: Past 3 months alcohol use days
time frame: 9 months follow-up
description: Number of days of any alcohol use in past 3 months
measure: Past 3 months alcohol use days
time frame: 12 months follow-up
description: Number of days of any alcohol use in past 3 months
measure: Past 3 months heavy episodic drinking days
time frame: 3 months follow-up
description: Number of days of heavy episodic drinking in past 3 months
measure: Past 3 months heavy episodic drinking days
time frame: 6 months follow-up
description: Number of days of heavy episodic drinking in past 3 months
measure: Past 3 months heavy episodic drinking days
time frame: 9 months follow-up
description: Number of days of heavy episodic drinking in past 3 months
measure: Past 3 months heavy episodic drinking days
time frame: 12 months follow-up
description: Number of days of heavy episodic drinking in past 3 months
measure: Perceived risk of harm
time frame: 3 months follow-up
description: Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking
measure: Perceived risk of harm
time frame: 6 months follow-up
description: Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking
measure: Perceived risk of harm
time frame: 9 months follow-up
description: Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking
measure: Perceived risk of harm
time frame: 12 months follow-up
description: Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking
measure: Drinking refusal self-efficacy
time frame: 3 months follow-up
description: Score on Drinking Refusal Self-Efficacy measure
measure: Drinking refusal self-efficacy
time frame: 6 months follow-up
description: Score on Drinking Refusal Self-Efficacy measure
measure: Drinking refusal self-efficacy
time frame: 9 months follow-up
description: Score on Drinking Refusal Self-Efficacy measure
measure: Drinking refusal self-efficacy
time frame: 12 months follow-up
description: Score on Drinking Refusal Self-Efficacy measure
arm group label: Usual Care
arm group type: No Intervention
description: Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care.
arm group label: Computer-facilitated screening and brief intervention
arm group type: Experimental
description: Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention.
intervention type: Behavioral
intervention name: Computer-facilitated Screening and Brief Intervention
description: cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, immediately followed by 2) computer-delivered brief psychoeducation on the health risks of substance use to prime patients for the clinician encounter, and 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling during the visit.
arm group label: Computer-facilitated screening and brief intervention
other name: cSBI
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sion K Harris, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Sion K Harris, PhD
phone: 857-218-4304
email: sion.harris@childrens.harvard.edu
last name: Lydia A. Shrier, MD, MPH
phone: 617-355-5133
email: lydia.shrier@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Harvard Medical School (HMS and HSDM)
investigator full name: Sion Kim Harris
investigator title: Associate Professor of Pediatrics
sharing ipd: Yes
ipd description: We will provide a variable codebook along with the dataset. We will make a de-identified version of the complete and cleaned study dataset available to the AAP's PROS Study Archive at study completion, as well as NIAAA Data Archive (NIAAADA).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Within 12 months of study completion.
ipd access criteria: We will share the dataset with external investigators when a data use agreement (DUA) is executed between Boston Children's Hospital and the institution of the person making the request. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project and schedule for data destruction.