Young People's Health Assessment as Treatment and Health Guide

NCT03817255 | Completed

• 1 other identifier: YP-HEALTH Pilot
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adolescent Behavior; Substance Use

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  2 months

Secondary Outcomes (3)

• The proportion of participants choosing to complete the paper questionnaire vs the online version.

  2 months

• Proportion of patients at follow-up stating that the procedures in the PC practices respected confidentiality.

  2 months

• PCPs critical comments regarding patient recruitment in their practices.

  1 month

Study Arms (2)

Substance use

EXPERIMENTAL

In this screening intervention, participants complete a substance use questionnaire (=intervention).

Other: Substance use questionnaire

Physical activity

ACTIVE COMPARATOR

In this screening control condition, participants complete a physical activity questionnaire (=control).

Other: Physical activity

Interventions

Substance use questionnaire OTHER

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

Substance use

Physical activity OTHER

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

Physical activity

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients consulting at the participating primary care practice during the recruitment period (2 months).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

Primary Care Unit, University of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 26251025 BACKGROUND

• Haller 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.

  PMID: 24616136 BACKGROUND

• Heather 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.

  PMID: 25076917 BACKGROUND

• McCambridge 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.

  PMID: 21998626 BACKGROUND

• Craig 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.

  PMID: 12900694 BACKGROUND

• Haller 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.

  PMID: 19275832 BACKGROUND

• Sanci 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.

  PMID: 16225445 BACKGROUND

• Haller 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.

  PMID: 16225455 BACKGROUND

MeSH Terms

Conditions

Adolescent Behavior; Substance-Related Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dagmar M Haller, Prof

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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. Thus, they are masked as to whether they are in the intervention or control group. Care provider: As they cannot have access to the participants' questionnaires, they are masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to either the intervention or the control condition.

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 25, 2019
• Study Start: September 1, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)