|- candidate number||10602|
|- NTR Number||NTR3169|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-nov-2011|
|- Secondary IDs||NL38040.091.11 CCMO|
|- Public Title||Aggression Replacement Training for adults.|
|- Scientific Title||Aggression Replacement Training for aggression-regulation disorder in adults: A randomized controlled out-patient study.|
|- hypothesis||Inappropriate aggressive behavior poses a great burden on society and is the main reason for referral to a forensic psychiatric setting. Although behavioral therapy like Aggression Replacement Training (ART) has been shown to be effective in the treatment of aggressive behavior in adolescents, little is known about the effectiveness in adults. In addition, the efficacy of these interventions for aggression need to be examined in relation to specific types of aggressive behaviors (i.e. reactive vs. proactive).|
|- Healt Condition(s) or Problem(s) studied||Agressive behavior|
|- Inclusion criteria||1. Age 18-55 years;|
2. Men and women;
4. Meeting DSM-IV criteria for Intermittent Explosive Disorder;
5. Score on Overt Aggression Scale-Modified for Outpatient Use (MOAS) of ≥ 15 or score on Social Dysfucntion and Aggression Scale (SDAS) of ≥ 5.
|- Exclusion criteria||1. IQ < 84;|
2. Lifetime history of (hypo)mania, schizophrenia, or delusional disorder;
3. Current major depression;
4. Current alcohol or substance dependence.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||28-jun-2012|
|- planned closingdate||31-dec-2014|
|- Target number of participants||66|
|- Interventions||The two modules ‘Anger Control’ enriched with psychomotor therapy and ‘Social skills’ of Aggression Replacement Training of Goldstein (ART) (Goldstein, Glick & Gibbs, 1998) aims to reduce the risk of recidivism of violent crimes with a pattern of reactive, interpersonal aggression. ART is a multimodal cognitive behavioural therapy and consists of three modules; social skills training, anger control training and psychomotor therapy. During the 10 sessions in 10 to 11 weeks, ART is implemented by two aggression replacement trainers who practice examples of ‘daily life situations’ with the trainees. The control group receives over the same period mentalization-based treatment based on improving the secure attachment and the ability to metalize and not directly focused on training of aggression regulation disorder and training of social skills.|
After the control group has completed this research, they will receive the ART. This data will not be collected.
|- Primary outcome||The main outcome of aggressive behavior will be the score on the Overt Aggression Scale-Modified for Outpatient Use (MOAS) and Social Dysfunction and Aggression Scale (SDAS). The MOAS and SDAS will be completed by different relevant informants. |
|- Secondary outcome||During the pre-screening, the MOAS will be completed to examine if the participant meets the inclusion criteria. To examine if the participant does meet the inclusion and does not meet the exclusion criteria the M.I.N.I., SCID-II, CIDI, PPI, Mate-Crimi and NLV will be completed during the screening. For the baseline and follow-up measure of the interventions, the IOA will be conducted to measure social skills. The IPAS, RPQ, AQ, ZAV, HIT and PSAP will be used to measure the effect of the Anger Control Training. To assess psychomotor training, heart rate and skin conductance will be measured. In addition, neurocognitive tasks will be conducted to examine how responders and non-responders profiles relate to forms and correlates of aggressive behaviour. |
|- Timepoints||The pre-screening, screening and baseline measurement will take place a month before the training starts.|
During the training questionnaires will be filled in at week 1, 2, 4, 6, 8 and 10.
The follow-up measurement will take place in the month after the training.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. Inge Scheper|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD Robbert J Verkes|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Netherlands Organization for Scientific Research (NWO)|
|- Brief summary||This study aims to evaluate the effectiveness of the modules ‘Anger control training’ enriched with psychomotor therapy and ‘Social Skills training’ of the Aggression Replacement Training of Goldstein (ART) on aggression regulation disorder in a forensic psychiatric outpatient setting. In addition, we aim to compare the profiles of treatment responders and non-responders in relation to contemporary dichotomized forms and correlates of aggressive behaviour (i.e. proactive versus reactive). Patients will be randomly assigned to an ART-intervention group and a control group. The intervention group receives 10 sessions of ART over a period of 10 weeks. Every week, the participants receive one session. The control group receives over the same period mentalization-based treatment (MBT) based on improving the secure attachment and the ability to metalize and not directly focused on training of aggression regulation disorder and training of social skills. Pretreatment, during treatment and post treatment measurements will be conducted on i.a. aggression, social skills, impulsivity, social information processing.|
|- Main changes (audit trail)|
|- RECORD||30-nov-2011 - 30-jun-2012|