|- candidate number||27366|
|- NTR Number||NTR6458|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-jun-2017|
|- Secondary IDs||2013-DP-3165 Ethics Review Board Faculty of Social and Behavioral Sciences, University of Amsterdam|
|- Public Title||Retraining automatic attention and approach tendencies to reduce levels of problematic cannabis and alcohol use for youth in juvenile detention centers. |
|- Scientific Title||Effectiveness of cognitive bias modification training in reducing levels of problematic cannabis and alcohol use in incarcerated juvenile delinquents.|
|- hypothesis||-We expect that the youth who receive an active CBM training on top of care-as-usual show a greater reduction in cannabis or alcohol misuse at follow up when compared their general population peers.
-We expect that CBM training works by reducing attention and approach bias towards the substance in question.
-We will explore whether the actively trained participants also show less delinquent behaviour when compared with the participants who received a placebo training.|
|- Healt Condition(s) or Problem(s) studied||Juvenile delinquents, Cognitive bias modification, Substance use|
|- Inclusion criteria||Youth placed in one of the participating institutions are eligible for inclusion in our screening measurement, provided they have been there for at least two weeks.
Youth who report substance use (cannabis and/or alcohol) during the 12 months prior to our screening measurement are eligible for inclusion in our CMB training.|
|- Exclusion criteria||- Insufficient proficiency with the Dutch language, as this will interfere with the participants' ability to understand the materials. |
- Youth placed in a Very Intensive Care (VIC) or Forensic Observation and Guidance ward (Forensische Observatie en Begeleidingsafdeling; FOBA) are not eligible for participation as the testing would be too intrusive in their treatment programs.
As the study uses reaction time measurements, there are some guidelines for processing the data
- With regard to individual trials, trials with reactions times below 200 ms or above 2000 ms will not be included in analyses
- With regard to complete tasks, participants with less that 70% accuracy will not be included in analyses
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2014|
|- planned closingdate||1-feb-2018|
|- Target number of participants||200|
|- Interventions||5 sessions of CBM comprised of two computerized tasks, an Approach-Avoid task to target approach biases and a Visual Probe task to target attention biases. CBM is done in addition to care-as-usual. Participants receive either an active training version or a placebo version of either task. |
|- Primary outcome||- Level of problematic cannabis use (CUDIT-R)|
- Level of problematic alcohol use (AUDIT)
|- Secondary outcome||- Approach bias (AAT scores)|
- Attention bias (VPT scores)
- Self-reported delinquency (ISRD)
- Criminal recidivism (police records)
|- Timepoints||- T0 (screening & substance use baseline): At least 2 weeks after placement in the institution.|
- T1 (cognitive biases baseline): As soon as screening results have shown them to be eligible and voluntary consent has been obtained.
- T2-T6 (training sessions): At least 24 hourse between sessions and preferably no more than a week apart.
- T7 (1st follow-up): 1 month after the last training session.
- T8 (2nd follow-up): 3 months after the last training session.
- T9 (3rd follow-up): 12 months after the last training session.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. H.S. van der Baan|
|- CONTACT for SCIENTIFIC QUERIES||Drs. H.S. van der Baan|
|- Sponsor/Initiator ||University of Amsterdam (UvA), Dutch Ministry of Security and Justice (VenJ)|
(Source(s) of Monetary or Material Support)
|Dutch Ministry of Security and Justice (VenJ)|
|- Brief summary||This study aims to assess the effectiveness of Cognitive Bias Modification (CBM) on top of care-as-usual in reducing levels of problematic cannabis and alcohol use. We focus specifically on youth placed in juvenile detention centres in the Netherlands, as this is a demographic that shows high levels of problematic substance use compared to their general population peers. The CBM training consists of two computerized tasks, either one of which is randomized to be either an active training or a placebo version. In this way we ensure that 75% of our participants receive at least one active training task while retaining a control group.|
|- Main changes (audit trail)|
|- RECORD||9-jun-2017 - 1-jul-2017|