Effective treatment of adolescents with aggression problems in clinical and non clinical settings

The focus in efficacy studies of treatment of aggression problems has mostly
been on recidivism rates of criminal acts in judicial terms (i.e. convictions)
and not so much on changes in aggressive behaviour. Risperidone and Aggression
replacement training (ART) have been found to be effective in numerous studies.
However there is little to no knowledge of the comparative or combined effects
of Risperidone and ART in relation to aggression among specific groups. The
efficacy of these interventions for aggression need to be examined in relation
to specific types of aggressive behaviours (i.e. impulsive vs. premeditated)
and among both responders and non-responders in various settings: schools,
outpatient, inpatient clinics and residential youth facilities. The present
study aims that by including a relatively broad group of subjects and by
conducting follow up measurements among responders and non responders, efficacy
questions will be answered from a real world perspective.

Main: to examine the comparative and combined effects of aggression replacement
training (ART) and Risperidone on aggressive behaviours among adolescents with
aggression problems ages 14-21 across clinical and non clinical settings
Secondary: to examine how treatment response and non responder profiles relate
to contemporary dichotomized forms and correlates of aggressive behaviour (i.e.
pro active vs. Reactive, cognitive distortions), location where the treatment
is offered

Ranomized (open label) treatment efficacy design with three treatment
condtions: ART, Risperidone and a combination of both

One group receives 30 sessions of Aggression replacement training (ART) over a
period of 15 weeks, another receives Risperidone daily doses from 0.5 to 2 mg.
A third group receives a combination of both treatments. In the case that the
demand outweighs the supply of the interventions at the study sites fourth
Waitlist control condition is used at the sites for the duration of the
treatment period. After which participants select one of the treatment
conditions they want to participate in.

Burdens and risks for participation to this study have been kept to a minimum.
Most questionnaires are completed by parents or care givers, to avoid the
participant being to burdened with this. Previous efficacy studies have pointed
out that aggressive individuals quality of life improves due to these
interventions: less contacts with judicial services or reduction of
convictions, inclusion in work school trajectories. Blood samples and physical
examination will only be applied to participants in the two treatment arms with
medication according to international consensus before start of the medication
and after three month of usage. A physical examination including taking a
medical history takes place before start of medication including an
electrocardiogram (if indicated). During the treatment phase physical
examinations including heart rate, blood pressure, length, weight and waistline
takes place every of the six visits and two times during the follow up phase.
All efforts are according to international consensus and best clinical
practise. Training (ART) will be given two times a week during a 15 week
treatment phase. All participants will be asked to fill in a number of
questionnaires before treatment phase for the benefit of the main and secondary
objectives. During treatment phase no further questionnaires will be handed
out. At the endpoint very few questionnaires will be repeated. All
questionnaires are listed below. The experimental conditions are similar to
clinical practise and the extent of burden for participants of the study is not
significantly other than in clinical practise except a few more questionnaires