Young People's Health Assessment as Treatment and Health Guide
Condition: Adolescent Behavior; Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Substance use questionnaire; Physical activity
Intervention type(s): Other; Other
Intervention description(s): Questions about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.; Questions about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to either the intervention or the control condition.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention