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Substance UseYP-HEALTHNCT04146714

Substance Use Screening to Encourage Behavior Change Among Young People in Primary Care

A study testing Substance use questionnaire and Physical activity questionnaire in people with Substance Use and Binge Drinking, run by Prof. Dagmar M. Haller at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study evaluates whether completing a short screening questionnaire about health behaviours in the waiting room before a primary care consultation decreases excessive substance use in young people aged 14 to 24 years. Read more about this study

Who is it for?
Ages 14 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Substance Use, Binge Drinking, Cannabis Use
What is being tested?
Substance use questionnaire and Physical activity questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
1 siteSwitzerland
Study dates
Jan 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Patients aged 14 to 24 years consulting at the participating primary care practice for any motive.

Who cannot join

  • Acute illness requiring immediate attention of the physician
  • Severe mental health conditions requiring treatment in a specialized setting
  • Young person not consulting as a patient at the practice (e.g. accompanying friend or partner)
  • Inability to read the trial information in French or to provide independent consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dagmar M Haller, MD, PhD contact

+41 22 379 50 61

dagmar.haller-hester@unige.ch

Eva Pfarrwaller, MD contact

+41 22 379 43 90

eva.pfarrwaller@unige.ch

Switzerland1 site
  • University Institute for Primary Care, Faculty of Medicine, University of Geneva

    Geneva

    Dagmar M Haller, MD, PhD, +41 22 379 43 90, dagmar.haller-hester@unige.ch

    Eva Pfarrwaller, MD, +41 22 379 43 90, eva.pfarrwaller@unige.ch

Other trials in Switzerland

About this study

Official title: Screening for Excessive Substance Use in the Waiting Room to Encourage Behavior Change Among Young People (YP-HEALTH): a Multi-center Randomized Controlled Trial in Primary Care

This study evaluates whether completing a short screening questionnaire about health behaviours in the waiting room before a primary care consultation decreases excessive substance use in young people aged 14 to 24 years. Young people consulting a primary care physician will randomly receive either a questionnaire about substance use or a questionnaire about physical activity. They will be contacted again 3, 6 and 12 months later and asked to complete a questionnaire about substance use. The proportion of young people with excessive substance use in each group will be compared. The researchers hypothesise that at three months this proportion will be lower in the group of young people having completed the initial questionnaire about substance use when compared to the group having completed the questionnaire about physical activity.

Read the detailed description

Background: Excessive alcohol and other substance use often begin in adolescence and contribute extensively to the development of non-communicable diseases and lifelong morbidity/mortality. In Switzerland, the prevalence of binge drinking (the most common mode of alcohol excess in adolescence) and other excessive substance use in young people is high, both in the general and in the primary care population. Since most young people visit a primary care physician at least once in any year, primary care offers an ideal context to individualize the preventive messages delivered in the community to favor behavior change.

Primary care physicians are encouraged to screen and provide brief interventions addressing excessive alcohol and other substance use in young people, but a range of barriers such as time constraints and insufficient training limit the implementation of these recommendations. Finding new ways of building on the potential of primary care whilst addressing these barriers is essential.

Several recent trials of brief primary care interventions showed substantial reductions (20% to 30%) in the proportion of participants who were excessive substance users at follow-up but no statistically significant differences between the intervention and control groups. Key authors have hypothesized that this could be due to assessment reactivity, i.e. when pre-intervention assessment itself encourages behavior change and thus serves as an intervention. Indeed, screening in the clinical context could act as an intervention and be as effective as a brief intervention within the consultation. To date this hypothesis has not been explored for young people attending primary care.

Methods: One of our previous trials (PRISM-Ado), and a pilot trial published in 2019, inform the methods of this parallel-group randomized controlled trial in primary care. Advisory panels of primary care physicians and young people contributed to the development of this protocol. Recruitment will take place in primary care practices in the French-speaking part of Switzerland. Young people between the ages of 14 and 24 years consulting for any health problem will be eligible. Up to 840 young people (approx 20 per practice) will be included and randomized to complete two different types of confidential pre-consultation screening surveys: one focusing on the assessment of binge drinking and other substance use (intervention group) and the other on physical activity (control group). Both surveys will include identical additional socio-demographic and health-related questions. The primary care physicians will not automatically have access to the answers provided in the surveys and participants will be free to decide if they wish to disclose them to their physician during the consultation. Follow-up phone interviews will take place at 3, 6 and 12 months. They will be identical for all participants and include all questions from the intervention and control questionnaires. The main outcome at 3 months follow-up will be the proportion of patients reporting binge drinking (≥1 episode) in the past 30 days. Secondary outcomes will include the proportion of young people reporting smoking (≥ 1 cigarette a day), electronic cigarette use (≥ once a day) and/or excessive cannabis use (≥1 joint/week) in the past 30 days. Analysis will be by intention to treat and will take into account clustering of participants within practices.

Expected value of the proposed trial: If our intervention proves effective, it will offer a simple, widely expandable method to encourage behavior change in young people consulting in primary care, thus contributing to a much-needed reduction in the burden of non-communicable diseases in the future. In addition, by providing a quantification of the effect of assessment reactivity per se, our study will provide key information for the design of future trials of interventions addressing substance use in young people attending primary care.

Being tested
Substance use questionnaire, Physical activity questionnaire
Medical subject headings
Substance-Related Disorders, Binge Drinking, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Substance use questionnaireOther

    Screening questionnaire about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.

  • Physical activity questionnaireOther

    Screening questionnaire about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).

Study groups in NCT04146714
Study groupRoleWhat they receive
Substance use screeningExperimentalParticipants complete a substance use questionnaire (=intervention).
Receives: Other: Substance use questionnaire
Physical activity screeningActive comparatorParticipants complete a physical activity questionnaire (=control).
Receives: Other: Physical activity questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.

    Patient self-report on follow-up telephone questionnaire. Binge drinking is defined as the consumption of five or more standard drinks in one occasion.

    Measured: 3 months

Secondary outcomes (11)
  1. Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 3 months

  2. Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 6 months

  3. Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 12 months

  4. Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 3 months

  5. Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 6 months

  6. Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 12 months

  7. Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 3 months

  8. Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 6 months

  9. Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.

    Patient self-report on follow-up telephone questionnaire.

    Measured: 12 months

  10. Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.

    Patient self-report on follow-up telephone questionnaire. Binge drinking is defined as the consumption of five or more standard drinks in one occasion.

    Measured: 6 months

  11. Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.

    Patient self-report on follow-up telephone questionnaire. Binge drinking is defined as the consumption of five or more standard drinks in one occasion.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04146714
Sponsor's protocol ID
YP-HEALTH
Acronym
YP-HEALTH
Status last verified
May 2024
First submitted
28 Oct 2019
Last updated
22 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Substance use questionnaire and Physical activity questionnaire in people with Substance Use and Binge Drinking, run by Prof. Dagmar M. Haller at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dagmar M Haller, MD, PhD (+41 22 379 50 61, dagmar.haller-hester@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients reporting one or more episodes of binge drinking in the past 30 days. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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