<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/NCT03817255</url>
  </required_header>
  <id_info>
    <org_study_id>YP-HEALTH Pilot</org_study_id>
    <nct_id>NCT03817255</nct_id>
  </id_info>
  <brief_title>Young People's Health Assessment as Treatment and Health Guide</brief_title>
  <acronym>YP-HEALTH</acronym>
  <official_title>Identification of Excessive Substance Use to Encourage Behaviour Change Among Young People in Primary Care: Pilot Study in Preparation for a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Geneva, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Geneva, Switzerland</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>
      Background: Excessive alcohol and other substance use in adolescence is prevalent and has&#xD;
      developmental consequences that extend into adulthood. In parallel with other public health&#xD;
      and clinical measures, early identification in primary care represents an important step to&#xD;
      address this problem. Screening and brief intervention by primary care physicians is&#xD;
      recommended but often fails to be implemented due to time constraints and other barriers.&#xD;
      Working hypothesis: Recent evidence suggests that simply asking individuals about their&#xD;
      substance use may in itself encourage behaviour change, regardless of the clinical&#xD;
      intervention that may follow. This hypothesis has not as yet been tested in a population of&#xD;
      young people consulting in primary care. The investigators hypothesise that inviting young&#xD;
      people to complete a brief substance use screening questionnaire in the waiting room before&#xD;
      their primary care consultation has the potential to lead to a decrease in substance use in&#xD;
      the months following this consultation.&#xD;
&#xD;
      Specific aims: The aim of this pilot project is to develop and test the methods for a future&#xD;
      randomized trial. The future trial will assess the effectiveness of pre-consultation&#xD;
      substance use screening, compared to screening for other behaviors, on subsequent substance&#xD;
      use in young people between the ages of 15 and 24 years consulting primary care physicians.&#xD;
&#xD;
      Expected value of the proposed project: The clinical context of primary care has the&#xD;
      potential to trigger behavior change in young people, thus favoring improved adult outcomes&#xD;
      in this population. If effective, pre-consultation substance use screening could contribute&#xD;
      to a reduction in excessive substance use among young people in a simple and cost-effective&#xD;
      way. This pilot study will provide precious feasibility data for the design of the related&#xD;
      cluster randomised trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Excessive alcohol and other substance use in adolescence has short and long term consequences&#xD;
      on health and contributes extensively to lifelong morbidity. Since prevalence of this&#xD;
      excessive use is high among young people consulting in primary care, primary care physicians&#xD;
      (PCPs) are well placed to address this problem. PCPs are encouraged to screen and provide&#xD;
      brief interventions addressing excessive substance use in young people, but a range of&#xD;
      barriers, such as time constraints and insufficient training, limits the implementation of&#xD;
      these recommendations in primary care practices. Several recent trials of brief primary care&#xD;
      interventions showed substantial reductions in the proportion of participants who were&#xD;
      excessive substance users at follow-up (20% to 30% reductions), but no statistically&#xD;
      significant differences between the intervention and control groups. Reductions in substance&#xD;
      use in the control group can be due to several factors: 1) Regression to the mean (repeat&#xD;
      participant responses show a trend towards the mean values for the participating population),&#xD;
      2) Research participation effects (e.g. Hawthorne effect, social desirability bias), 3)&#xD;
      Historical trends which affect the entire population, such as reductions in per capita&#xD;
      alcohol use in relation to public health measures, 4) Assessment reactivity, when&#xD;
      pre-intervention assessment itself encourages behavior change and thus serves as an&#xD;
      intervention. In a randomized design these factors should apply equally to both groups, and&#xD;
      additional effects of the tested intervention may still be visible. If reductions in&#xD;
      substance use at follow-up are due to assessment reactivity, this suggests screening in the&#xD;
      clinical context could act as an intervention in itself and be as effective as a brief&#xD;
      intervention within the consultation. To date this hypothesis has not been explored in a&#xD;
      population of young people attending primary care.&#xD;
&#xD;
      Aim of the Trial:&#xD;
&#xD;
      To assess the effectiveness of simply screening participants for excessive substance use&#xD;
      before the consultation in the waiting room in reducing the prevalence of excessive substance&#xD;
      use in young people attending primary care.&#xD;
&#xD;
      Objectives of the pilot study:&#xD;
&#xD;
        1. To pilot all methods for a randomized trial of the substance use screening intervention&#xD;
           (patient recruitment, intervention and control conditions, follow-up procedures),&#xD;
&#xD;
        2. To obtain feedback from PCPs and patients in relation to the feasibility and&#xD;
           acceptability of the proposed methods for the trial.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The intervention screening questionnaire will be based on an instrument developed for&#xD;
      previous trials. Questions for the control condition (about physical activity) will be based&#xD;
      on a validated physical activity questionnaire (International Physical Activity&#xD;
      Questionnaire, IPAQ). As recommended in guidelines for adolescent health and primary care&#xD;
      research, both young people and PCPs will be involved in the development of the screening&#xD;
      tools. A reference group of young people and of PCPs will be established in order to benefit&#xD;
      from their input into the design of the study.&#xD;
&#xD;
      The intended trial procedure including recruitment of young people, screening for health risk&#xD;
      behaviours and follow-up will be piloted in 6 primary care practices in the canton of Geneva&#xD;
      in order to inform the final design of the trial.&#xD;
&#xD;
      The physicians involved in the advisory-group will be invited to undertake the pilot study in&#xD;
      their own practices. They will be asked to include a minimum of five patients each. Patients&#xD;
      will be randomized to either the intervention or the control questionnaire.&#xD;
&#xD;
      Patients will be recruited using a similar procedure as the one developed for one of our&#xD;
      previous studies, the PRISM-Ado trial. Prior to the consultation, eligible patients will be&#xD;
      invited by the practice assistant to participate in the study. Participants will be given an&#xD;
      information and consent form, and will be given the choice to complete the study&#xD;
      questionnaire either online (using a QR code to access the questionnaire on their phone) or&#xD;
      in a paper format, in the waiting room. Participants will be asked to provide a contact phone&#xD;
      number (mobile phone) to allow follow-up assessments 1 month following the consultation.&#xD;
      Young people involved in the PRISM-Ado study underlined that they would be less likely to&#xD;
      respond honestly to a screening questionnaire if it were to be used by the doctor in the&#xD;
      consultation. Therefore this pre-consultation questionnaire will be entirely anonymous and&#xD;
      will not be available for the PCPs to help them identify at-risk consumers. Written informed&#xD;
      consent will be obtained from all young people before they complete the screening survey.&#xD;
      Patient questionnaires will be coded to ensure anonymity.&#xD;
&#xD;
      A meeting of participating doctors will be organized to receive feed-back on all aspects of&#xD;
      the study. Participating patients will be asked to provide their contact details (mobile&#xD;
      phone number) so that they may be contacted to provide feed-back on the screening&#xD;
      questionnaire and study procedure.&#xD;
&#xD;
      Physicians' and young people's characteristics will be summarized using frequencies for&#xD;
      categorical data and means and standard deviations for continuous data. This summary will&#xD;
      provide us with an initial profile of youth consulting in the practices and will inform&#xD;
      planning and sample size calculations for the randomized trial. Participant feed-back will be&#xD;
      summarized in a qualitative way.&#xD;
&#xD;
      Importance of the expected results:&#xD;
&#xD;
      The results of this pilot study will provide precious information for the final design of the&#xD;
      randomised trial in primary care. These results will be published in a medical journal and&#xD;
      presented at medical conferences. The consequences of excessive substance use in adolescence&#xD;
      extend into adulthood. The investigators are hopeful that the interventions developed and&#xD;
      piloted in this project will provide new ways of ensuring better health for young people&#xD;
      today and in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">December 4, 2018</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>Participants are assigned to either the intervention or the control condition.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants: Although they cannot be masked to the content of the intervention (questionnaire), they are only informed that the study is about health behaviours in general. Thus, they are masked as to whether they are in the intervention or control group.&#xD;
Care provider: As they cannot have access to the participants' questionnaires, they are masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The number of patients recruited by each PCP within a 2-month period</measure>
    <time_frame>2 months</time_frame>
    <description>A maximum of 10 patients were to be recruited by each of the 6 participating primary care physicians (PCPs) within a 2-month period. The target number was 5 patients per PCP, but the recruitment period was not prolonged if this target was not met.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of PCPs who recruited at least 5 patients within a 2-month period</measure>
    <time_frame>2 months</time_frame>
    <description>The participating PCPs were asked to recruit a minimum of 5 patients, but the recruitment period was limited to 2 months (for practical and financial reasons). All participating PCPs participated in the pilot study thinking that they would be able to recruit 5 patients. This outcome thus gives us an idea about whether PCPs had a realistic idea about their ability to recruit a sufficient number of eligible patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of eligible patients who agreed to participate</measure>
    <time_frame>2 months</time_frame>
    <description>Measurement tool : A form completed by the PCPs assistants, documenting how many patients were approached, how many refused, and how many had exclusion criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of PCPs who respected the pre-determined sequence of questionnaires (randomized sequence).</measure>
    <time_frame>2 months</time_frame>
    <description>Each PCP received a unique randomized sequence of intervention and control questionnaires, in envelopes numbered from 1 to 10. At the end of the two-month recruitment period, they returned all envelopes (completed and empty questionnaires). The research team checked whether the sequence from 1 to 10 had been respected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of participating patients who returned a completed baseline questionnaire (=patients included in study).</measure>
    <time_frame>2 months</time_frame>
    <description>The PCPs did not check whether the questionnaires had been completed correctly (for confidentiality reasons). This proportion was thus determined by the research team. A questionnaire was considered &quot;complete&quot; if: 1. Consent form was signed, 2. Phone number was given, and 3. at least 50% of questions had been answered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients included in the study who answered the follow-up questionnaire at one month.</measure>
    <time_frame>2 months</time_frame>
    <description>Patients who could be contacted by phone one month after the baseline questionnaire, and who agreed to answer the second questionnaire (over the phone, with a member of the research team).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients at follow-up who consumed alcohol at least once in the last 30 days.</measure>
    <time_frame>2 months</time_frame>
    <description>Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients at follow-up who consumed cannabis at least once in the last 30 days.</measure>
    <time_frame>2 months</time_frame>
    <description>Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants choosing to complete the paper questionnaire vs the online version.</measure>
    <time_frame>2 months</time_frame>
    <description>Questionnaires were distributed in paper form, but could be filled in on a mobile device using a link (QR code).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients at follow-up stating that the procedures in the PC practices respected confidentiality.</measure>
    <time_frame>2 months</time_frame>
    <description>At the end of the phone questionnaire, the researcher asked: &quot; Did you feel that the procedures used in the study were confidential ? &quot;, followed by an open question asking to elaborate on the context in which the questionnaire was completed (waiting room, presence of other patients/people).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCPs critical comments regarding patient recruitment in their practices.</measure>
    <time_frame>1 month</time_frame>
    <description>Narrative synthesis of meeting notes, collected during a group meeting with participating PCPs, by asking open-ended questions and open group discussion. PCPs were asked to describe difficulties with recruitment and to elaborate how these difficulties could be overcome, stimulating discussion and exchange within the group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Adolescent Behavior</condition>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Substance use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this screening intervention, participants complete a substance use questionnaire (=intervention).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this screening control condition, participants complete a physical activity questionnaire (=control).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Substance use questionnaire</intervention_name>
    <description>Questions about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.</description>
    <arm_group_label>Substance use</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>Questions about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).</description>
    <arm_group_label>Physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients consulting at the participating primary care practice during the recruitment&#xD;
             period (2 months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute illness requiring immediate attention of the physician&#xD;
&#xD;
          -  Severe mental health conditions requiring treatment in a specialized setting&#xD;
&#xD;
          -  Inability to read the trial information in French&#xD;
&#xD;
          -  Person not consulting as a patient (e.g. parent of a child consulting a pediatrician,&#xD;
             accompanying friend or partner).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dagmar M Haller, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Care Unit, University of Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Haller DM, Meynard A, Lefebvre D, Hasselgard-Rowe J, Broers B, Narring F. Excessive substance use among young people consulting family doctors: a cross-sectional study. Fam Pract. 2015 Oct;32(5):500-4. doi: 10.1093/fampra/cmv058. Epub 2015 Aug 5.</citation>
    <PMID>26251025</PMID>
  </reference>
  <reference>
    <citation>Haller DM, Meynard A, Lefebvre D, Ukoumunne OC, Narring F, Broers B. Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial. CMAJ. 2014 May 13;186(8):E263-72. doi: 10.1503/cmaj.131301. Epub 2014 Mar 10.</citation>
    <PMID>24616136</PMID>
  </reference>
  <reference>
    <citation>Heather N. Interpreting null findings from trials of alcohol brief interventions. Front Psychiatry. 2014 Jul 16;5:85. doi: 10.3389/fpsyt.2014.00085. eCollection 2014.</citation>
    <PMID>25076917</PMID>
  </reference>
  <reference>
    <citation>McCambridge J, Kypri K. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials. PLoS One. 2011;6(10):e23748. doi: 10.1371/journal.pone.0023748. Epub 2011 Oct 5.</citation>
    <PMID>21998626</PMID>
  </reference>
  <reference>
    <citation>Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.</citation>
    <PMID>12900694</PMID>
  </reference>
  <reference>
    <citation>Haller DM, Meynard A, Lefebvre D, Tylee A, Narring F, Broers B. Brief intervention addressing excessive cannabis use in young people consulting their GP: a pilot study. Br J Gen Pract. 2009 Mar;59(560):166-72. doi: 10.3399/bjgp09X419529.</citation>
    <PMID>19275832</PMID>
  </reference>
  <reference>
    <citation>Sanci LA, Sawyer SM, Kang MS, Haller DM, Patton GC. Confidential health care for adolescents: reconciling clinical evidence with family values. Med J Aust. 2005 Oct 17;183(8):410-4. doi: 10.5694/j.1326-5377.2005.tb07104.x.</citation>
    <PMID>16225445</PMID>
  </reference>
  <reference>
    <citation>Haller DM, Sanci LA, Patton GC, Sawyer SM. Practical evidence in favour of mature-minor consent in primary care research. Med J Aust. 2005 Oct 17;183(8):439. doi: 10.5694/j.1326-5377.2005.tb07114.x. No abstract available.</citation>
    <PMID>16225455</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Geneva, Switzerland</investigator_affiliation>
    <investigator_full_name>Prof. Dagmar M. Haller</investigator_full_name>
    <investigator_title>Professor</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>
    <ipd_description>We do not plan to make individual participant data available for this feasibility study for data protection reasons, because there will be a very limited number of participants.</ipd_description>
  </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/NCT03817255
org study id: YP-HEALTH Pilot
nct id: NCT03817255
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Excessive alcohol and other substance use in adolescence is prevalent and has
      developmental consequences that extend into adulthood. In parallel with other public health
      and clinical measures, early identification in primary care represents an important step to
      address this problem. Screening and brief intervention by primary care physicians is
      recommended but often fails to be implemented due to time constraints and other barriers.
      Working hypothesis: Recent evidence suggests that simply asking individuals about their
      substance use may in itself encourage behaviour change, regardless of the clinical
      intervention that may follow. This hypothesis has not as yet been tested in a population of
      young people consulting in primary care. The investigators hypothesise that inviting young
      people to complete a brief substance use screening questionnaire in the waiting room before
      their primary care consultation has the potential to lead to a decrease in substance use in
      the months following this consultation.

      Specific aims: The aim of this pilot project is to develop and test the methods for a future
      randomized trial. The future trial will assess the effectiveness of pre-consultation
      substance use screening, compared to screening for other behaviors, on subsequent substance
      use in young people between the ages of 15 and 24 years consulting primary care physicians.

      Expected value of the proposed project: The clinical context of primary care has the
      potential to trigger behavior change in young people, thus favoring improved adult outcomes
      in this population. If effective, pre-consultation substance use screening could contribute
      to a reduction in excessive substance use among young people in a simple and cost-effective
      way. This pilot study will provide precious feasibility data for the design of the related
      cluster randomised trial.
Background:

      Excessive alcohol and other substance use in adolescence has short and long term consequences
      on health and contributes extensively to lifelong morbidity. Since prevalence of this
      excessive use is high among young people consulting in primary care, primary care physicians
      (PCPs) are well placed to address this problem. PCPs are encouraged to screen and provide
      brief interventions addressing excessive substance use in young people, but a range of
      barriers, such as time constraints and insufficient training, limits the implementation of
      these recommendations in primary care practices. Several recent trials of brief primary care
      interventions showed substantial reductions in the proportion of participants who were
      excessive substance users at follow-up (20% to 30% reductions), but no statistically
      significant differences between the intervention and control groups. Reductions in substance
      use in the control group can be due to several factors: 1) Regression to the mean (repeat
      participant responses show a trend towards the mean values for the participating population),
      2) Research participation effects (e.g. Hawthorne effect, social desirability bias), 3)
      Historical trends which affect the entire population, such as reductions in per capita
      alcohol use in relation to public health measures, 4) Assessment reactivity, when
      pre-intervention assessment itself encourages behavior change and thus serves as an
      intervention. In a randomized design these factors should apply equally to both groups, and
      additional effects of the tested intervention may still be visible. If reductions in
      substance use at follow-up are due to assessment reactivity, this suggests screening in the
      clinical context could act as an intervention in itself and be as effective as a brief
      intervention within the consultation. To date this hypothesis has not been explored in a
      population of young people attending primary care.

      Aim of the Trial:

      To assess the effectiveness of simply screening participants for excessive substance use
      before the consultation in the waiting room in reducing the prevalence of excessive substance
      use in young people attending primary care.

      Objectives of the pilot study:

        1. To pilot all methods for a randomized trial of the substance use screening intervention
           (patient recruitment, intervention and control conditions, follow-up procedures),

        2. To obtain feedback from PCPs and patients in relation to the feasibility and
           acceptability of the proposed methods for the trial.

      Methods:

      The intervention screening questionnaire will be based on an instrument developed for
      previous trials. Questions for the control condition (about physical activity) will be based
      on a validated physical activity questionnaire (International Physical Activity
      Questionnaire, IPAQ). As recommended in guidelines for adolescent health and primary care
      research, both young people and PCPs will be involved in the development of the screening
      tools. A reference group of young people and of PCPs will be established in order to benefit
      from their input into the design of the study.

      The intended trial procedure including recruitment of young people, screening for health risk
      behaviours and follow-up will be piloted in 6 primary care practices in the canton of Geneva
      in order to inform the final design of the trial.

      The physicians involved in the advisory-group will be invited to undertake the pilot study in
      their own practices. They will be asked to include a minimum of five patients each. Patients
      will be randomized to either the intervention or the control questionnaire.

      Patients will be recruited using a similar procedure as the one developed for one of our
      previous studies, the PRISM-Ado trial. Prior to the consultation, eligible patients will be
      invited by the practice assistant to participate in the study. Participants will be given an
      information and consent form, and will be given the choice to complete the study
      questionnaire either online (using a QR code to access the questionnaire on their phone) or
      in a paper format, in the waiting room. Participants will be asked to provide a contact phone
      number (mobile phone) to allow follow-up assessments 1 month following the consultation.
      Young people involved in the PRISM-Ado study underlined that they would be less likely to
      respond honestly to a screening questionnaire if it were to be used by the doctor in the
      consultation. Therefore this pre-consultation questionnaire will be entirely anonymous and
      will not be available for the PCPs to help them identify at-risk consumers. Written informed
      consent will be obtained from all young people before they complete the screening survey.
      Patient questionnaires will be coded to ensure anonymity.

      A meeting of participating doctors will be organized to receive feed-back on all aspects of
      the study. Participating patients will be asked to provide their contact details (mobile
      phone number) so that they may be contacted to provide feed-back on the screening
      questionnaire and study procedure.

      Physicians' and young people's characteristics will be summarized using frequencies for
      categorical data and means and standard deviations for continuous data. This summary will
      provide us with an initial profile of youth consulting in the practices and will inform
      planning and sample size calculations for the randomized trial. Participant feed-back will be
      summarized in a qualitative way.

      Importance of the expected results:

      The results of this pilot study will provide precious information for the final design of the
      randomised trial in primary care. These results will be published in a medical journal and
      presented at medical conferences. The consequences of excessive substance use in adolescence
      extend into adulthood. The investigators are hopeful that the interventions developed and
      piloted in this project will provide new ways of ensuring better health for young people
      today and in the future.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to either the intervention or the control condition.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants: Although they cannot be masked to the content of the intervention (questionnaire), they are only informed that the study is about health behaviours in general. Thus, they are masked as to whether they are in the intervention or control group.
Care provider: As they cannot have access to the participants' questionnaires, they are masked.
measure: The number of patients recruited by each PCP within a 2-month period
time frame: 2 months
description: A maximum of 10 patients were to be recruited by each of the 6 participating primary care physicians (PCPs) within a 2-month period. The target number was 5 patients per PCP, but the recruitment period was not prolonged if this target was not met.
measure: The proportion of PCPs who recruited at least 5 patients within a 2-month period
time frame: 2 months
description: The participating PCPs were asked to recruit a minimum of 5 patients, but the recruitment period was limited to 2 months (for practical and financial reasons). All participating PCPs participated in the pilot study thinking that they would be able to recruit 5 patients. This outcome thus gives us an idea about whether PCPs had a realistic idea about their ability to recruit a sufficient number of eligible patients.
measure: The proportion of eligible patients who agreed to participate
time frame: 2 months
description: Measurement tool : A form completed by the PCPs assistants, documenting how many patients were approached, how many refused, and how many had exclusion criteria.
measure: The proportion of PCPs who respected the pre-determined sequence of questionnaires (randomized sequence).
time frame: 2 months
description: Each PCP received a unique randomized sequence of intervention and control questionnaires, in envelopes numbered from 1 to 10. At the end of the two-month recruitment period, they returned all envelopes (completed and empty questionnaires). The research team checked whether the sequence from 1 to 10 had been respected.
measure: The proportion of participating patients who returned a completed baseline questionnaire (=patients included in study).
time frame: 2 months
description: The PCPs did not check whether the questionnaires had been completed correctly (for confidentiality reasons). This proportion was thus determined by the research team. A questionnaire was considered "complete" if: 1. Consent form was signed, 2. Phone number was given, and 3. at least 50% of questions had been answered.
measure: The proportion of patients included in the study who answered the follow-up questionnaire at one month.
time frame: 2 months
description: Patients who could be contacted by phone one month after the baseline questionnaire, and who agreed to answer the second questionnaire (over the phone, with a member of the research team).
measure: The proportion of patients at follow-up who consumed alcohol at least once in the last 30 days.
time frame: 2 months
description: Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
measure: The proportion of patients at follow-up who consumed cannabis at least once in the last 30 days.
time frame: 2 months
description: Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
measure: The proportion of participants choosing to complete the paper questionnaire vs the online version.
time frame: 2 months
description: Questionnaires were distributed in paper form, but could be filled in on a mobile device using a link (QR code).
measure: Proportion of patients at follow-up stating that the procedures in the PC practices respected confidentiality.
time frame: 2 months
description: At the end of the phone questionnaire, the researcher asked: " Did you feel that the procedures used in the study were confidential ? ", followed by an open question asking to elaborate on the context in which the questionnaire was completed (waiting room, presence of other patients/people).
measure: PCPs critical comments regarding patient recruitment in their practices.
time frame: 1 month
description: Narrative synthesis of meeting notes, collected during a group meeting with participating PCPs, by asking open-ended questions and open group discussion. PCPs were asked to describe difficulties with recruitment and to elaborate how these difficulties could be overcome, stimulating discussion and exchange within the group.
arm group label: Substance use
arm group type: Experimental
description: In this screening intervention, participants complete a substance use questionnaire (=intervention).
arm group label: Physical activity
arm group type: Active Comparator
description: In this screening control condition, participants complete a physical activity questionnaire (=control).
intervention type: Other
intervention name: Substance use questionnaire
description: Questions about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.
arm group label: Substance use
intervention type: Other
intervention name: Physical activity
description: Questions about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).
arm group label: Physical activity
criteria: 
gender: All
minimum age: 15 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dagmar M Haller, Prof
role: Principal Investigator
affiliation: University of Geneva
facility: 
country: Switzerland
citation: Haller DM, Meynard A, Lefebvre D, Hasselgard-Rowe J, Broers B, Narring F. Excessive substance use among young people consulting family doctors: a cross-sectional study. Fam Pract. 2015 Oct;32(5):500-4. doi: 10.1093/fampra/cmv058. Epub 2015 Aug 5.
PMID: 26251025
citation: Haller DM, Meynard A, Lefebvre D, Ukoumunne OC, Narring F, Broers B. Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial. CMAJ. 2014 May 13;186(8):E263-72. doi: 10.1503/cmaj.131301. Epub 2014 Mar 10.
PMID: 24616136
citation: Heather N. Interpreting null findings from trials of alcohol brief interventions. Front Psychiatry. 2014 Jul 16;5:85. doi: 10.3389/fpsyt.2014.00085. eCollection 2014.
PMID: 25076917
citation: McCambridge J, Kypri K. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials. PLoS One. 2011;6(10):e23748. doi: 10.1371/journal.pone.0023748. Epub 2011 Oct 5.
PMID: 21998626
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PMID: 12900694
citation: Haller DM, Meynard A, Lefebvre D, Tylee A, Narring F, Broers B. Brief intervention addressing excessive cannabis use in young people consulting their GP: a pilot study. Br J Gen Pract. 2009 Mar;59(560):166-72. doi: 10.3399/bjgp09X419529.
PMID: 19275832
citation: Sanci LA, Sawyer SM, Kang MS, Haller DM, Patton GC. Confidential health care for adolescents: reconciling clinical evidence with family values. Med J Aust. 2005 Oct 17;183(8):410-4. doi: 10.5694/j.1326-5377.2005.tb07104.x.
PMID: 16225445
citation: Haller DM, Sanci LA, Patton GC, Sawyer SM. Practical evidence in favour of mature-minor consent in primary care research. Med J Aust. 2005 Oct 17;183(8):439. doi: 10.5694/j.1326-5377.2005.tb07114.x. No abstract available.
PMID: 16225455
responsible party type: Principal Investigator
investigator affiliation: University of Geneva, Switzerland
investigator full name: Prof. Dagmar M. Haller
investigator title: Professor
mesh term: Substance-Related Disorders
sharing ipd: No
ipd description: We do not plan to make individual participant data available for this feasibility study for data protection reasons, because there will be a very limited number of participants.