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.
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.
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
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.
- Conditions
- Substance Use, Binge Drinking, Cannabis Use, Adolescent Behavior
- 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 group | Role | What they receive |
|---|---|---|
| Substance use screening | Experimental | Participants complete a substance use questionnaire (=intervention). Receives: Other: Substance use questionnaire |
| Physical activity screening | Active comparator | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted31 Oct 2019
- Study startJan 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Prof. Dagmar M. Haller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dagmar M. Haller, University of Geneva, Switzerland
- Investigators
- Dagmar M Haller, MD,PhD, Principal investigator, Faculty of Medicine, University of Geneva
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04146714
- Acronym / sponsor ID
- YP-HEALTH / YP-HEALTH
- Conditions
- Substance Use, Binge Drinking, Cannabis Use, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Prof. Dagmar M. HallerUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substance use screening | Experimental | Other: Substance use questionnaireParticipants complete a substance use questionnaire (=intervention). |
| Physical activity screening | Active comparator | Other: Physical activity questionnaireParticipants complete a physical activity questionnaire (=control). |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients aged 14 to 24 years consulting at the participating primary care practice for any motive.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substance use questionnaireScreening questionnaire about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey. | Other | Substance use screening |
| Physical activity questionnaireScreening questionnaire about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ). | Other | Physical activity screening |
Primary outcome
Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.
Time frame: 3 months
Patient self-report on follow-up telephone questionnaire. Binge drinking is defined as the consumption of five or more standard drinks in one occasion.
11 secondary outcomes
Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.
Time frame: 3 months
Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.
Time frame: 6 months
Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.
Time frame: 12 months
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Time frame: 3 months
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Time frame: 6 months
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Time frame: 12 months
Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.
Time frame: 3 months
Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.
Time frame: 6 months
Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.
Time frame: 12 months
Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.
Time frame: 6 months
Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dagmar M Haller, MD,PhD principal investigator
Faculty of Medicine, University of Geneva
1 site in 1 country: see every site and its status.
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.