| - candidate number | 6130 |
| - NTR Number | NTR1920 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 21-jul-2009 |
| - Secondary IDs | 120520011 ZonMW |
| - Public Title | Preventure: preventing binge drinking among Dutch youth. |
| - Scientific Title | Preventure: preventing binge drinking among Dutch youth. |
| - ACRONYM | N/A |
| - hypothesis | It will be expected that the implementation of the intervention Preventure will reduce alcohol use (binge drinking) by young adolescents (12-16 year). |
| - Healt Condition(s) or Problem(s) studied | Alcohol use among young adolescents |
| - Inclusion criteria | 1. Age between 12 and 16 years; 2. A life time prevalence of alcohol use (i.e. having drunk at least one glass of alcohol at least once in their life); 3. Belonging to one of the four personality risk groups with an increased risk for (future) heavy drinking: Anxiety Sensitivity (AS), Sensation Seeking (SS), Negative Thinking (NT) and Impulsivity (IMP). |
| - Exclusion criteria | 1. Age younger than 12 and older than 16 years; 2. No life time prevalence of alcohol use (i.e. not having drunk at least one glass of alcohol at least once in their life); 3. Not belonging to one of the four personality risk groups with an increased risk for (future) heavy drinking: Anxiety Sensitivity (AS), Sensation Seeking (SS), Negative Thinking (NT) and impulsivity (IMP). |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-sep-2009 |
| - planned closingdate | 1-mrt-2011 |
| - Target number of participants | 512 |
| - Interventions | The intervention involves two 90-minutes group sessions, carried out at the participants’ schools. The interventions are provided by a qualified counselor. The intervention incorporates three main components: a psycho-educational component, a motivational interviewing component and a cognitive-behavioral component. In the first session, participants are guided in a goal-setting exercise designed to enhance motivation to explore personality and ways of coping with one’s personality. Psycho-educational strategies are used to educate participants about the target personality variable (NT, AS, IMP and SS) and the associated problematic coping behaviors, such as interpersonal dependence, avoidance, aggression, risky behaviors and substance misuse. They are then introduced to the cognitive-behavioral model and then guided in dissecting a personal experience according to the physical, cognitive and behavioral components of an emotional response. All exercises discuss thoughts, emotions and behaviors in a personality-specific way. In the second session, participants are encouraged to identify and challenge personality-specific cognitive distortions that lead to problematic behaviors. The NT intervention focuses on challenging negative-biased cognitions (i.e., generalization, internalization), whereas catastrophic cognitions are challenged in the AS intervention. The IMP intervention focuses on aggressive thinking and not thinking things through, while the SS intervention involves challenging cognitive distortions associated with reward-seeking and boredom-susceptibility. Students assigned to the control group receive no further intervention above the standard drug education sessions provided in the National Curriculum, which the intervention group will also receive. |
| - Primary outcome | Over a course of one year, the effectiveness of Preventure is assessed. The intervention is targeted at the reduction of binge drinking among young adolescents. Reduce the percentage of binge drinking (> than five drinks). |
| - Secondary outcome | 1. Reduce the average alcohol consumption on a weekly and weekend basis of young adolescents; 2. Reduce the prevalence of drinking related problems among young adolescents; 3. Reduce the prevalence of social emotional problems among young adolescents; 4. Reduce the prevalence of behavioral problems among young adolescents. |
| - Timepoints | 1. September/October 2009 Screening (To); 2. April/May 2010 (T1); 3. September/October 2010 (T2); 4. January/February 2011 (T3). |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Msc J. Lammers |
| - CONTACT for SCIENTIFIC QUERIES | Dr. L. Lemmers |
| - Sponsor/Initiator | Trimbos-institute - Netherlands Institute of Mental Health and Addiction |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | The effectiveness of the intervention Preventure will be tested in a Randomized Controlled Trial (RCT) with two conditions: an experimental condition, receiving the intervention and a control condition not receiving the intervention. Following the initial screening survey there will be three follow up measurements: at 2, 6 and 12 months. A survey sample of 4000 students is needed to get the required 256 students in both conditions. The intervention is manual based and involves two 90 minutes group sessions, carried out at the participants' schools. The group sessions are provided by a qualified counselor. The intervention incorporate the principles from the motivational and cognitive-behavioral literature. The intervention is tailored to the personality risk profiles of students: Anxiety Sensivity, Sensation Seeking, Impulsivity and Negative Thinking. |
| - Main changes (audit trail) | |
| - RECORD | 21-jul-2009 - 10-okt-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl