Contact information
Type
Scientific
Primary contact
Dr Floor Scheepers
ORCID ID
Contact details
Vluchtheuvellaan 6
Zetten
6670 AC
Netherlands
+31 (0)48 846 96 11
f.scheepers@karakter.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
III.04.1001
Study information
Scientific title
Effective treatment of adolescents with aggression problems in clinical and non-clinical settings: a multicentre randomised treatment efficacy trial
Acronym
TOA
Study hypothesis
Primary:
To examine the comparative and combined effects of aggression replacement training (ART) and risperidone on aggressive behaviours among adolescents with aggression problems aged 12 - 21 years across clinical and non-clinical settings.
Secondary:
To examine how treatment response and non-responder profiles relate to contemporary dichotomised forms and correlates of aggressive behaviour (i.e. pro-active versus reactive, cognitive distortions), location where the treatment is offered.
Ethics approval
Ethical Board CMO Arnhem/Nijmegen, pending approval as of 22/01/2010
Study design
Multicentre randomised treatment efficacy trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Mr Tim Tiemissen [t.tiemissen@karakter.com] for more information
Condition
Aggression regulation problems
Intervention
Patients are randomised to one of three treatment groups:
1. 30 sessions of aggression replacement training (ART) over a period of 14 weeks
2. Risperidone daily doses from 0.5 to 2 mg
3. Combination of both treatments
Treatment:
In the treatment phase, subjects will receive 14 weeks of each of the treatment conditions. After the treatment phase assessment of quantity, typology and severity of aggressive behaviour is conducted again, as well as the secondary outcome variables regarding the social background and clinical symptoms, social skills, aggressive thoughts and thinking styles.
Follow up:
After a period of three months and again at six months follow up measurements are conducted relating to our primary hypothesis. Medication is continued during these 6 months. Participants which have not responded to either or both of the treatment conditions are offered other treatments or are referred to the health care services which suit the problems and demand of the participants at that time.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
A % decrease in severity and frequency of aggressive behaviour as observed on the MOAS, completed by at least two different informants at baseline and after the intervention period (including follow up measurements after three and six months). A decrease of 40% counts as a response to treatment, between 20 - 30% decrease as a partial response and a decrease below 20% as a non-response.
Secondary outcome measures
1. Impulsive-Premeditated Aggression Scale (IPAS) at pre-screening, and week 15
2. Clinical Global Impression 'Severity of Illness' (CGI-S) Scale at screening and week 15
3. REactive-PROactive Aggression Questionnaire (REPRO) (for parents, teachers, nurses or pedagogical workers) at screening and week 15
4. Instrument for Reactive and Proactive Aggression (IRPA) at screening and week 15
5. How I Think (HIT) questionnaire at screening and week 15
6. Social Support Questionnaire (SSQ) at screening and week 15
7. Socio-moral Reflection Objective Measure-Short Form (SROM-OSF) at screening and week 15
8. Inventory of callous-unemotional traits (ICU) at screening and week 15
9. Reactive-Proactive Aggression Questionnaire (RPQ) (for youths) at screening and week 15
Overall trial start date
01/07/2010
Overall trial end date
01/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Full scale intelligence quotient (IQ) at least 80; total IQ (TIQ) less than 75, verbal IQ (VIQ) at least 80
2. Minimal score on Modified Overt Aggression Scale (MOAS) of 5 on both initial screenings
3. Age lies between 12 and 21 years, either sex
4. (Psychiatric) medication free at beginning of the screening procedure
5. Minimal motivation among participant and family
6. Reading level of Avi 6 or 7
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
30 per treatment condition, total 120
Participant exclusion criteria
1. Previous ART or risperidone (6 months)
2. Psychotic condition
3. Severe depression
4. Severe substance dependency
5. Suicidal tendencies
6. Pregnancy or lactation
7. Major medical problems
8. Epilepsy
9. Cardiovascular diseases
10. Regular medication which strongly interacts with risperidone
11. Unable to sign informed consent
Recruitment start date
01/07/2010
Recruitment end date
01/12/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vluchtheuvellaan 6
Zetten
6670 AC
Netherlands
Sponsor information
Organisation
Karakter - Child and Adolescent Psychiatry (Netherlands)
Sponsor details
Horalaan 5
Ede
6717 LX
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Karakter - Child and Adolescent Psychiatry (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list