Condition category
Mental and Behavioural Disorders
Date applied
05/03/2012
Date assigned
30/04/2012
Last edited
29/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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 facilitator’s characteristics
6.2.1. Basic therapeutic skills (short version)
6.2.2. Critical life events
6.2.3. SLE
6.3. Patient’s 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

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

http://www.bmbf.de/en/

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

federal

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24975110

Publication citations

  1. 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.

Additional files

Editorial Notes

29/07/2016: Plain English summary added.