Health network: alcohol in adolescence
| ISRCTN | ISRCTN31234060 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31234060 |
| Secondary identifying numbers | 01KQ1002B |
- Submission date
- 05/03/2012
- Registration date
- 30/04/2012
- Last edited
- 26/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
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
| Phone | +49 (0)40 7410 52206 |
|---|---|
| thomasius@uke.uni-hamburg.de |
Study information
| Study design | Controlled randomized longitudinal cross-sectional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Brief motivational intervention in adolescents treated in emergency departments for acute alcohol intoxication: a randomized controlled trial |
| Study objectives | 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(s) | Chamber of Psychotherapists Ethics Committee, Hamburg, Germany, 12/07/2011 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 16/07/2011 |
| Completion date | 16/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 153 |
| Total final enrolment | 316 |
| Key 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 |
| Key exclusion criteria | 1. Severe injuries as a result of the intoxication 2. Cognitive difficulties or language barriers |
| Date of first enrolment | 16/07/2011 |
| Date of final enrolment | 16/01/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
D-20246
Germany
Sponsor information
Government
c/o Dr. Britta Sommersberg
Deutsches Zentrum für Luft- und Raumfahrt e.V.
Heinrich-Konen-Str. 1
Bonn
D-53227
Germany
| Phone | +49 (0)228 3821 1736 |
|---|---|
| britta.sommersberg@dlr.de | |
| Website | http://www.bmbf.de/en/ |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/06/2014 | Yes | No | |
| Results article | results | 01/02/2017 | 26/02/2021 | Yes | No |
Editorial Notes
26/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
29/07/2016: Plain English summary added.
