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

ISRCTN	ISRCTN21681959
DOI	https://doi.org/10.1186/ISRCTN21681959
Secondary identifying numbers	III.04.1001

Submission date: 22/01/2010
Registration date: 06/04/2010
Last edited: 29/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Floor Scheepers
Scientific

Vluchtheuvellaan 6
Zetten
6670 AC
Netherlands

Phone	+31 (0)48 846 96 11
Email	f.scheepers@karakter.com

Study information

Study design	Multicentre randomised treatment efficacy trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact Mr Tim Tiemissen [t.tiemissen@karakter.com] for more information
Scientific title	Effective treatment of adolescents with aggression problems in clinical and non-clinical settings: a multicentre randomised treatment efficacy trial
Study acronym	TOA
Study objectives	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(s)	Ethical Board CMO Arnhem/Nijmegen, pending approval as of 22/01/2010
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2010
Completion date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	30 per treatment condition, total 120
Key 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
Key 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
Date of first enrolment	01/07/2010
Date of final enrolment	01/12/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Vluchtheuvellaan 6

Zetten
6670 AC
Netherlands

Sponsor information

Karakter - Child and Adolescent Psychiatry (Netherlands)
Hospital/treatment centre

Horalaan 5
Ede
6717 LX
Netherlands

Website	http://www.karakter.com
"ROR"	https://ror.org/044jw3g30

Funders

Funder type

Hospital/treatment centre

Karakter - Child and Adolescent Psychiatry (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan