NCT04146714

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

October 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
5.2 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

October 28, 2019

Last Update Submit

May 21, 2024

Conditions

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (11)

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

    3 months

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

    6 months

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

    12 months

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

    3 months

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

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Substance use screening

EXPERIMENTAL

Participants complete a substance use questionnaire (=intervention).

Other: Substance use questionnaire

Physical activity screening

ACTIVE COMPARATOR

Participants complete a physical activity questionnaire (=control).

Other: Physical activity questionnaire

Interventions

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

Substance use screening

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

Physical activity screening

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Geneva, Switzerland

Location

MeSH Terms

Conditions

Substance-Related DisordersBinge DrinkingAdolescent Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related DisordersAlcohol DrinkingDrinking BehaviorBehavior

Study Officials

  • Dagmar M Haller, MD,PhD

    Faculty of Medicine, University of Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dagmar M Haller, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 31, 2019

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations