Adolescent BehaviorYP-HEALTHNCT03817255
Young People's Health Assessment as Treatment and Health Guide
A study testing Substance use questionnaire and Physical activity in people with Adolescent Behavior and Substance Use, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Substance Use
- What is being tested?
- Substance use questionnaire and Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2018to 4 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients consulting at the participating primary care practice during the recruitment period (2 months).
Who cannot join
- Acute illness requiring immediate attention of the physician
- Severe mental health conditions requiring treatment in a specialized setting
- Inability to read the trial information in French
- Person not consulting as a patient (e.g. parent of a child consulting a pediatrician, accompanying friend or partner).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Excessive Substance Use to Encourage Behaviour Change Among Young People in Primary Care: Pilot Study in Preparation for a Randomized Trial
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.
Read the 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:
- To pilot all methods for a randomized trial of the substance use screening intervention (patient recruitment, intervention and control conditions, follow-up procedures),
- 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.
- Conditions
- Adolescent Behavior, Substance Use
- Being tested
- Substance use questionnaire, Physical activity
- Medical subject headings
- Adolescent Behavior, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance use questionnaireOther
Questions about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.
Physical activityOther
Questions about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).
| Study group | Role | What they receive |
|---|---|---|
| Substance use | Experimental | In this screening intervention, participants complete a substance use questionnaire (=intervention). Receives: Other: Substance use questionnaire |
| Physical activity | Active comparator | In this screening control condition, participants complete a physical activity questionnaire (=control). Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients recruited by each PCP within a 2-month period
A maximum of 10 patients were to be recruited by each of the 6 participating primary care physicians (PCPs) within a 2-month period. The target number was 5 patients per PCP, but the recruitment period was not prolonged if this target was not met.
Measured: 2 months
The proportion of PCPs who recruited at least 5 patients within a 2-month period
The participating PCPs were asked to recruit a minimum of 5 patients, but the recruitment period was limited to 2 months (for practical and financial reasons). All participating PCPs participated in the pilot study thinking that they would be able to recruit 5 patients. This outcome thus gives us an idea about whether PCPs had a realistic idea about their ability to recruit a sufficient number of eligible patients.
Measured: 2 months
The proportion of eligible patients who agreed to participate
Measurement tool : A form completed by the PCPs assistants, documenting how many patients were approached, how many refused, and how many had exclusion criteria.
Measured: 2 months
The proportion of PCPs who respected the pre-determined sequence of questionnaires (randomized sequence).
Each PCP received a unique randomized sequence of intervention and control questionnaires, in envelopes numbered from 1 to 10. At the end of the two-month recruitment period, they returned all envelopes (completed and empty questionnaires). The research team checked whether the sequence from 1 to 10 had been respected.
Measured: 2 months
The proportion of participating patients who returned a completed baseline questionnaire (=patients included in study).
The PCPs did not check whether the questionnaires had been completed correctly (for confidentiality reasons). This proportion was thus determined by the research team. A questionnaire was considered "complete" if: 1. Consent form was signed, 2. Phone number was given, and 3. at least 50% of questions had been answered.
Measured: 2 months
The proportion of patients included in the study who answered the follow-up questionnaire at one month.
Patients who could be contacted by phone one month after the baseline questionnaire, and who agreed to answer the second questionnaire (over the phone, with a member of the research team).
Measured: 2 months
The proportion of patients at follow-up who consumed alcohol at least once in the last 30 days.
Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
Measured: 2 months
The proportion of patients at follow-up who consumed cannabis at least once in the last 30 days.
Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
Measured: 2 months
Secondary outcomes (3)
The proportion of participants choosing to complete the paper questionnaire vs the online version.
Questionnaires were distributed in paper form, but could be filled in on a mobile device using a link (QR code).
Measured: 2 months
Proportion of patients at follow-up stating that the procedures in the PC practices respected confidentiality.
At the end of the phone questionnaire, the researcher asked: " Did you feel that the procedures used in the study were confidential ? ", followed by an open question asking to elaborate on the context in which the questionnaire was completed (waiting room, presence of other patients/people).
Measured: 2 months
PCPs critical comments regarding patient recruitment in their practices.
Narrative synthesis of meeting notes, collected during a group meeting with participating PCPs, by asking open-ended questions and open group discussion. PCPs were asked to describe difficulties with recruitment and to elaborate how these difficulties could be overcome, stimulating discussion and exchange within the group.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Sep 2018
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies 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
- Model description
- Participants are assigned to either the intervention or the control condition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dagmar M. Haller, University of Geneva, Switzerland
- Investigators
- Dagmar M Haller, Prof, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817255
- Sponsor's protocol ID
- YP-HEALTH Pilot
- Acronym
- YP-HEALTH
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual participant data available for this feasibility study for data protection reasons, because there will be a very limited number of participants.
Publications
Haller DM, Meynard A, Lefebvre D, Hasselgard-Rowe J, Broers B, Narring F. Excessive substance use among young people consulting family doctors: a cross-sectional study. Fam Pract. 2015 Oct;32(5):500-4. doi: 10.1093/fampra/cmv058. Epub 2015 Aug 5.
PubMed 26251025Haller DM, Meynard A, Lefebvre D, Ukoumunne OC, Narring F, Broers B. Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial. CMAJ. 2014 May 13;186(8):E263-72. doi: 10.1503/cmaj.131301. Epub 2014 Mar 10.
PubMed 24616136Heather N. Interpreting null findings from trials of alcohol brief interventions. Front Psychiatry. 2014 Jul 16;5:85. doi: 10.3389/fpsyt.2014.00085. eCollection 2014.
PubMed 25076917McCambridge J, Kypri K. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials. PLoS One. 2011;6(10):e23748. doi: 10.1371/journal.pone.0023748. Epub 2011 Oct 5.
PubMed 21998626Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Haller DM, Meynard A, Lefebvre D, Tylee A, Narring F, Broers B. Brief intervention addressing excessive cannabis use in young people consulting their GP: a pilot study. Br J Gen Pract. 2009 Mar;59(560):166-72. doi: 10.3399/bjgp09X419529.
PubMed 19275832Sanci LA, Sawyer SM, Kang MS, Haller DM, Patton GC. Confidential health care for adolescents: reconciling clinical evidence with family values. Med J Aust. 2005 Oct 17;183(8):410-4. doi: 10.5694/j.1326-5377.2005.tb07104.x.
PubMed 16225445Haller DM, Sanci LA, Patton GC, Sawyer SM. Practical evidence in favour of mature-minor consent in primary care research. Med J Aust. 2005 Oct 17;183(8):439. doi: 10.5694/j.1326-5377.2005.tb07114.x. No abstract available.
PubMed 16225455
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Excessive Substance Use to Encourage Behaviour Change Among Young People in Primary Care: Pilot Study in Preparation for a Randomized Trial
- ClinicalTrials.gov ID
- NCT03817255
- Acronym / sponsor ID
- YP-HEALTH / YP-HEALTH Pilot
- Conditions
- Adolescent Behavior, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 25 Jan 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.
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:
- To pilot all methods for a randomized trial of the substance use screening intervention (patient recruitment, intervention and control conditions, follow-up procedures),
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to either the intervention or the control condition.
| Arm | Type | Receives |
|---|---|---|
| Substance use | Experimental | Other: Substance use questionnaireIn this screening intervention, participants complete a substance use questionnaire (=intervention). |
| Physical activity | Active comparator | Other: Physical activityIn this screening control condition, participants complete a physical activity questionnaire (=control). |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients consulting at the participating primary care practice during the recruitment period (2 months).
Key exclusion criteria (4 listed)
- Acute illness requiring immediate attention of the physician
- Severe mental health conditions requiring treatment in a specialized setting
- Inability to read the trial information in French
- Person not consulting as a patient (e.g. parent of a child consulting a pediatrician, accompanying friend or partner).
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 questionnaireQuestions about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey. | Other | Substance use |
| Physical activityQuestions about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ). | Other | Physical activity |
Primary outcome
The number of patients recruited by each PCP within a 2-month period
Time frame: 2 months
A maximum of 10 patients were to be recruited by each of the 6 participating primary care physicians (PCPs) within a 2-month period. The target number was 5 patients per PCP, but the recruitment period was not prolonged if this target was not met.
The proportion of PCPs who recruited at least 5 patients within a 2-month period
Time frame: 2 months
The participating PCPs were asked to recruit a minimum of 5 patients, but the recruitment period was limited to 2 months (for practical and financial reasons). All participating PCPs participated in the pilot study thinking that they would be able to recruit 5 patients. This outcome thus gives us an idea about whether PCPs had a realistic idea about their ability to recruit a sufficient number of eligible patients.
The proportion of eligible patients who agreed to participate
Time frame: 2 months
Measurement tool : A form completed by the PCPs assistants, documenting how many patients were approached, how many refused, and how many had exclusion criteria.
The proportion of PCPs who respected the pre-determined sequence of questionnaires (randomized sequence).
Time frame: 2 months
Each PCP received a unique randomized sequence of intervention and control questionnaires, in envelopes numbered from 1 to 10. At the end of the two-month recruitment period, they returned all envelopes (completed and empty questionnaires). The research team checked whether the sequence from 1 to 10 had been respected.
The proportion of participating patients who returned a completed baseline questionnaire (=patients included in study).
Time frame: 2 months
The PCPs did not check whether the questionnaires had been completed correctly (for confidentiality reasons). This proportion was thus determined by the research team. A questionnaire was considered "complete" if: 1. Consent form was signed, 2. Phone number was given, and 3. at least 50% of questions had been answered.
The proportion of patients included in the study who answered the follow-up questionnaire at one month.
Time frame: 2 months
Patients who could be contacted by phone one month after the baseline questionnaire, and who agreed to answer the second questionnaire (over the phone, with a member of the research team).
The proportion of patients at follow-up who consumed alcohol at least once in the last 30 days.
Time frame: 2 months
Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
The proportion of patients at follow-up who consumed cannabis at least once in the last 30 days.
Time frame: 2 months
Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
3 secondary outcomes
The proportion of participants choosing to complete the paper questionnaire vs the online version.
Time frame: 2 months
Proportion of patients at follow-up stating that the procedures in the PC practices respected confidentiality.
Time frame: 2 months
PCPs critical comments regarding patient recruitment in their practices.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 26251025Haller DM, Meynard A, Lefebvre D, Hasselgard-Rowe J, Broers B, Narring F. Excessive substance use among young people consulting family doctors: a cross-sectional study. Fam Pract. 2015 Oct;32(5):500-4. doi: 10.1093/fampra/cmv058. Epub 2015 Aug 5.
- Background: PubMed 24616136Haller DM, Meynard A, Lefebvre D, Ukoumunne OC, Narring F, Broers B. Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial. CMAJ. 2014 May 13;186(8):E263-72. doi: 10.1503/cmaj.131301. Epub 2014 Mar 10.
- Background: PubMed 25076917Heather N. Interpreting null findings from trials of alcohol brief interventions. Front Psychiatry. 2014 Jul 16;5:85. doi: 10.3389/fpsyt.2014.00085. eCollection 2014.
- Background: PubMed 21998626McCambridge J, Kypri K. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials. PLoS One. 2011;6(10):e23748. doi: 10.1371/journal.pone.0023748. Epub 2011 Oct 5.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 19275832Haller DM, Meynard A, Lefebvre D, Tylee A, Narring F, Broers B. Brief intervention addressing excessive cannabis use in young people consulting their GP: a pilot study. Br J Gen Pract. 2009 Mar;59(560):166-72. doi: 10.3399/bjgp09X419529.
- Background: PubMed 16225445Sanci LA, Sawyer SM, Kang MS, Haller DM, Patton GC. Confidential health care for adolescents: reconciling clinical evidence with family values. Med J Aust. 2005 Oct 17;183(8):410-4. doi: 10.5694/j.1326-5377.2005.tb07104.x.
- Background: PubMed 16225455Haller DM, Sanci LA, Patton GC, Sawyer SM. Practical evidence in favour of mature-minor consent in primary care research. Med J Aust. 2005 Oct 17;183(8):439. doi: 10.5694/j.1326-5377.2005.tb07114.x. No abstract available.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available for this feasibility study for data protection reasons, because there will be a very limited number of participants.
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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. This study is not recruiting at the moment.
Dagmar M Haller, Prof principal investigator
University of Geneva, Switzerland
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 in people with Adolescent Behavior and Substance Use, run by University of Geneva, Switzerland 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: finished, as of the sponsor's last update on 25 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients recruited by each PCP within a 2-month period (time frame: 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817255, which also lists 8 linked publications.
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 25 Jan 2019.