Condition category
Mental and Behavioural Disorders
Date applied
22/01/2010
Date assigned
06/04/2010
Last edited
29/07/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.karakter.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes