Condition category
Mental and Behavioural Disorders
Date applied
30/11/2015
Date assigned
22/04/2016
Last edited
15/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Uppsala University

Sponsor details

Department of Obstetrics and Gynecology
Women's and Children's Health
Akademiska sjukhuset
Uppsala
SE-751 85 Uppsala
Sweden

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes