Plain English Summary
Background and study aims
In Germany the number of children and teenagers treated for drinking too much alcohol (acute alcohol intoxication) has more than doubled between 2000 and 2010. This has led to the development of the prevention program “HaLT-Hart am Limit” (“Stop – close to the limit”), which involves offering a counselling session to children and teenagers who are being treated for heavy drinking in emergency departments. The program is currently carried out at more than 140 locations in Germany, but its effectiveness has not been tested. The aim of this study is to test the effectiveness of a brief motivational intervention for heavy drinking children and adolescents in emergency departments.
Who can participate?
Children and adolescents under the age of 18 who are being treated for acute alcohol intoxication in one of the six participating hospitals
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the control group receive treatment as usual, which consists of information on counselling agencies and the recommendation to contact one, and handouts on the negative effects of drinking. Participants in the intervention group receive a counselling session, information on the negative effects of drinking, and information on counselling agencies and the recommendation to contact one. Intervention group parents/caregivers are also offered a counselling session. Participants in the intervention group are also contacted by telephone 6 weeks after leaving hospital for a 5-10 minute booster.
What are the possible benefits and risks of participating?
There are no known risks for participants.
Where is the study run from?
The study takes place in the emergency departments of six hospitals treating children and young adults in the City of Hamburg, Germany.
When is the study starting and how long is it expected to run for?
July 2011 to July 2014
Who is funding the study?
German Federal Ministry of Education and Research (BMBF)
Who is the main contact?
Prof. Rainer Thomasius
thomasius@uke.uni-hamburg.de
Trial website
http://www.psychenet.de/ueber-psychenet/teilprojekte/alkohol-im-jugendalter.html
Contact information
Type
Scientific
Primary contact
Prof Rainer Thomasius
ORCID ID
Contact details
German Center for Addiction Research in Childhood and Adolescence [Deutsches Zentrum für Suchtfragen des Kindes und Jugendalters]
University Medical Center Hamburg-Eppendorf
Martinistr. 52
Hamburg
D-20246
Germany
+49 (0)40 7410 52206
thomasius@uke.uni-hamburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01KQ1002B
Study information
Scientific title
Brief motivational intervention in adolescents treated in emergency departments for acute alcohol intoxication: a randomized controlled trial
Acronym
Study hypothesis
1. Children and adolescents who receive a manualised brief motivational intervention (BMI) after being treated for alcohol intoxication in an emergency department will reduce their binge-drinking frequency significantly when compared with controls.
2. Children and adolescents who receive a BMI (intervention group) will significantly more often seek for help in the care system than do children and adolescents who do not receive the BMI (control group).
Ethics approval
Chamber of Psychotherapists Ethics Committee, Hamburg, Germany, 12/07/2011
Study design
Controlled randomized longitudinal cross-sectional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
At-risk alcohol use in adolescents
Intervention
The study design is a two-group controlled-randomised, longitudinal and cross-sectional trial with post intervention measures and follow-ups at 3 and 6 months.
Intervention group (BMI + TAU)
Participants in the intervention group receive a manualised brief motivational intervention (BMI) which takes 45-minutes and is delivered by trained facilitators before discharge from hospital (one session only). Participants additionally receive information on cooperating youth- and family-oriented counselling agencies combined with the recommendation to contact a counselling agency and handouts on negative effects of alcohol use for children and adolescents which represents treatment as usual (TAU). Parents/caregivers also receive a counselling session in hospital. Participants in the intervention group are being contacted by telephone 6 weeks after hospitalization for a 5 -10 minute booster to enhance motivation to pursue alcohol-related goals as set in hospital. Participants are contacted by telephone 3 and 6 months after hospitalization for follow-up assessment.
Control group (TAU)
Participants in the control group receive treatment as usual (TAU) which consists of information on cooperating youth- and family-oriented counselling agencies combined with the recommendation to contact a counselling agency, and handouts on negative effects of alcohol use in children and adolescents. Participants are contacted by telephone 3 and 6 months after hospitalization for follow-up assessment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Binge-drinking frequency past 3 and 6 months
2. Asking for the help in the care system (follow-up treatment/counselling)
Secondary outcome measures
1. Negative consequences of alcohol use [Rutgers Alcohol Problem Index (RAPI)]
2. Drug-related risk-behaviour (RAFFT)
3. Alcohol-related risk-behaviour (CRAFFT)
4. Motivation to change
5. Exploratory analysis regarding:
5.1. Characteristics of adolescents and parents who contact the counselling agencies for help on alcohol problems
5.2. Characteristics of adolescents who reduce or stop their at-risk alcohol consumption patterns with or without the BMI or counselling agencies
6. Measures:
6.1. Vulnerability / protectivity:
6.1.1. SCL-K-9 (short version)
6.1.2. SPS-J
6.1.3. RS-13 (short version)
6.2. Perceived facilitators characteristics
6.2.1. Basic therapeutic skills (short version)
6.2.2. Critical life events
6.2.3. SLE
6.3. Patients treatment satisfaction
6.3.1. ZUF-8
6.4. Social support
6.4.1. FsozU-K14 (short version)
6.5. Parenting style
6.5.1. Alabama Parenting Questionnaire
6.6. Familiy functioning
6.6.1. Familienbögen (FB-S)
Overall trial start date
16/07/2011
Overall trial end date
16/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age range up to 17.9 years
2. Treatment in a pediatric emergency department due to acute alcohol intoxication
3. Informed consent given by participant and parent(s)/caregivers
4. Sufficient mental-cognitive receptiveness
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
153
Participant exclusion criteria
1. Severe injuries as a result of the intoxication
2. Cognitive difficulties or language barriers
Recruitment start date
16/07/2011
Recruitment end date
16/01/2014
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Center Hamburg-Eppendorf
Hamburg
D-20246
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research [Bundesministerium für Bildung und Forschung] (BMBF) (Germany)
Sponsor details
c/o Dr. Britta Sommersberg
Deutsches Zentrum für Luft- und Raumfahrt e.V.
Heinrich-Konen-Str. 1
Bonn
D-53227
Germany
+49 (0)228 3821 1736
britta.sommersberg@dlr.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung (ref: 01KQ1002B)
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24975110
Publication citations
-
Protocol
Diestelkamp S, Arnaud N, Sack PM, Wartberg L, Daubmann A, Thomasius R, Brief motivational intervention for adolescents treated in emergency departments for acute alcohol intoxication - a randomized-controlled trial., BMC Emerg Med, 2014, 14, 13, doi: 10.1186/1471-227X-14-13.