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Substance Use Screening to Encourage Behavior Change Among Young People in Primary Care (YP-HEALTH)

Primary Purpose

Substance Use, Binge Drinking, Cannabis Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Substance use questionnaire
Physical activity questionnaire
Sponsored by
Prof. Dagmar M. Haller
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

14 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Substance use screening

Physical activity screening

Arm Description

Participants complete a substance use questionnaire (=intervention).

Participants complete a physical activity questionnaire (=control).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Patient self-report on follow-up telephone questionnaire.
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Patient self-report on follow-up telephone questionnaire.
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Patient self-report on follow-up telephone questionnaire.
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.
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.
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.
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.
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.

Full Information

First Posted
October 28, 2019
Last Updated
November 15, 2022
Sponsor
Prof. Dagmar M. Haller
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1. Study Identification

Unique Protocol Identification Number
NCT04146714
Brief Title
Substance Use Screening to Encourage Behavior Change Among Young People in Primary Care
Acronym
YP-HEALTH
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dagmar M. Haller

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Binge Drinking, Cannabis Use, Adolescent Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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 and not specifically about substance use. Thus, they are masked as to whether they are in the intervention or control group.
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Substance use screening
Arm Type
Experimental
Arm Description
Participants complete a substance use questionnaire (=intervention).
Arm Title
Physical activity screening
Arm Type
Active Comparator
Arm Description
Participants complete a physical activity questionnaire (=control).
Intervention Type
Other
Intervention Name(s)
Substance use questionnaire
Intervention Description
Screening questionnaire about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.
Intervention Type
Other
Intervention Name(s)
Physical activity questionnaire
Intervention Description
Screening questionnaire about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).
Primary Outcome Measure Information:
Title
Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.
Description
Patient self-report on follow-up telephone questionnaire. Binge drinking is defined as the consumption of five or more standard drinks in one occasion.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
3 months
Title
Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
6 months
Title
Proportion of patients reporting smoking one or more cannabis joints per week in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
12 months
Title
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
3 months
Title
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
6 months
Title
Proportion of patients reporting smoking at least one cigarette per day in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
12 months
Title
Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
3 months
Title
Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
6 months
Title
Proportion of patients reporting electronic cigarette use at least once per day in the last 30 days.
Description
Patient self-report on follow-up telephone questionnaire.
Time Frame
12 months
Title
Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.
Description
Patient self-report on follow-up telephone questionnaire. Binge drinking is defined as the consumption of five or more standard drinks in one occasion.
Time Frame
6 months
Title
Proportion of patients reporting one or more episodes of binge drinking in the past 30 days.
Description
Patient self-report on follow-up telephone questionnaire. Binge drinking is defined as the consumption of five or more standard drinks in one occasion.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Patients aged 14 to 24 years consulting at the participating primary care practice for any motive. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dagmar M Haller, MD, PhD
Phone
+41 22 379 50 61
Email
dagmar.haller-hester@unige.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Pfarrwaller, MD
Phone
+41 22 379 43 90
Email
eva.pfarrwaller@unige.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dagmar M Haller, MD,PhD
Organizational Affiliation
Faculty of Medicine, University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Institute for Primary Care, Faculty of Medicine, University of Geneva
City
Geneva
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagmar M Haller, MD, PhD
Phone
+41 22 379 43 90
Email
dagmar.haller-hester@unige.ch
First Name & Middle Initial & Last Name & Degree
Eva Pfarrwaller, MD
Phone
+41 22 379 43 90
Email
eva.pfarrwaller@unige.ch

12. IPD Sharing Statement

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

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