Plain English Summary
Background and study aims
Mental health problems and alcohol abuse are among the most common causes of morbidity (illness) and mortality (death) in young people. At this age, people also have a greater risk of being a victim of a violent crime (violence victimisation), and the link between violence victimisation and ill-health in youth is well established. To address this situation, screening and treatment for high-risk alcohol drinking and violence victimisation in youth in health care settings have been backed by organisations such as the WHO and the American Academy of Pediatrics. However, despite the recommended guidelines, it has not yet been agreed how this should be performed. The aim of this study is to find out whether a brief program for young people who show high-risk alcohol drinking and/or violence victimisation during a regular visit to a youth health centre in Sweden is effective.
Who can participate?
People aged between 15 and 22, who currently visit a participating Youth Health Centre for counselling.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group are interviewed about alcohol/drug use and are asked structured questions about whether they have been a victim of violence (mental, physical, sexual or family), in addition to their regular visit with a midwife or social worker. Those who have been a victim of violence are offered further counselling and are referred to appropriate services. Those who have been a victim of violence and show high-risk drinking also receive help for their alcohol related problems. Participants in the second group are also interviewed about their alcohol habits and whether they have been a victim of violence, but only receive the standard visit from a midwife or social worker. After 3, 6 and 12 months, participants in both groups complete a number of questionnaires in order to measure their drinking behaviour and violence victimisation.
What are the possible benefits and risks of participating?
Participants may benefit from being able to identify their problems so that they are able to work on resolving any issues they may have, either with violence victimisation or risky drinking. There is a risk for victims of violence that talking about it may be distressing, however these participants will be offered further counselling.
Where is the study run from?
Four Youth Health Centres in Västernorrland County (Sweden)
When is the study starting and how long is it expected to run for?
January 2012 to June 2013
Who is funding the study?
Crime Victim Fund (Sweden)
Who is the main contact?
Professor Ulf Högberg
ulf.hogberg@kbh.uu.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ulf Högberg
ORCID ID
http://orcid.org/0000-0002-2121-7511
Contact details
Department of Women's and Children's Health
Uppsala University
Uppsala
SE-751 85
Sweden
+46 18 611 52 46
ulf.hogberg@kbh.uu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Violence and alcohol abuse intervention for Swedish youth – routine enquiry and counselling for violence and Motivational Interviewing for risk drinking in Swedish youth health centres
Acronym
Study hypothesis
1. The percentage of youths victimized will decrease after routine enquiry and counselling
2. The percentage of youths with risk drinking of alcohol will decrease for those having Motivational Interviewing
Ethics approval
Regional Ethical Review Board in Umeå, 24/05/2011, ref: 2011-110-31Ö
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
1. Exposure and victimization to violence among young people
2. Risk drinking of alcohol among young people
Intervention
The participants, youth visiting four Youth Centers in the County Västernorrland in Sweden, are randomized into the intervention or the control group. A statistician, who was not otherwise involved in the study, generated a random allocation sequence in Blockrand in R version 2.12, and stratified by different youth health centres. Randomization occurred in blocks of eight, using sealed envelopes.
Intervention arm: The intervention arm consists of two main parts. In the first part, a routine enquiry is made about violence exposure within a health dialogue to all participants. Those in need receive counselling from midwife or social worker and receive a referral to social authorities, school/police, guardians or child/adult psychiatrist if deemed necessary. In the second part, participants are screened for alcohol use using the AUDIT-C (3-item alcohol screen). Those identified as engaging in risky drinking receive motivational interviewing (MI) within the same visit. MI is a goal-oriented, client-centered counseling style for eliciting behavior change by helping clients to recognise their problems and change their behaviour.
Control arm: Participants receive a regular visit from a midwife or social worker but answered the same questions about violence victimization and alcohol/substance use in a pre-structured questionnaire after the visit.
Participants in both groups are reassessed at 3, 6 and 12 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Violence victimization is measured using the visual analogue score (VAS) at baseline, 3, 6 and 12 months
2. Risky alcohol drinking behaviour is measured using the AUDI-C score and Bingedrinking AUIDIT-score at baseline, 3, 6 and 12 months
Secondary outcome measures
1. Perceived general health is measured using at baseline, 3, 6 and 12 months
2. Somatic pain symptoms are measured using at baseline, 3, 6 and 12 months
3. Absence from school/work is measured using at baseline, 3, 6 and 12 months
Overall trial start date
01/01/2012
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 15 and 22
2. Visiting a participating Youth Health Centre, in Västernorrland county (Sweden) for of counselling about sexual and reproductive health, social, psychological or physical problems, or ill-health
Participant type
Other
Age group
Mixed
Gender
Both
Target number of participants
500 women and 500 men
Participant exclusion criteria
1. Severe mental disease
2. Not going to a regular school due to mental retardation
Recruitment start date
01/01/2012
Recruitment end date
10/06/2013
Locations
Countries of recruitment
Sweden
Trial participating centre
Youth Health Center Sundsvall
Tullgatan 15
Sundsvall
SE-85231
Sweden
Trial participating centre
Youth Health Center Sollefteå
Kungsgatan 10 A
Sollefteå
SE-88130
Sweden
Trial participating centre
Youth Health Center Örnsköldsvik
Bergsgatan 9
Örnsköldsvik
SE-89134
Sweden
Trial participating centre
Youth Health Center Kramfors
Limstagatan 5
Kramfors
SE-87230
Sweden
Funders
Funder type
Charity
Funder name
Crime Victim Fund (Brottsofferfonden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in peer reviewed journals. The study also is included in the PhD Thesis of Dr Anna Palm at Uppsala University.
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26743590 [added 18/01/2019]
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27909178 [added 18/01/2019]
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27289105 [added 18/01/2019]