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

Completed

• Conditions: Aggression regulation problems; Mental and Behavioural Disorders; Mixed disorders of conduct and emotions

• Registration Number: ISRCTN21681959
• Lead Sponsor: Karakter - Child and Adolescent Psychiatry (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Impulsive-Premeditated Aggression Scale (IPAS) at pre-screening, and week 15<br>2. Clinical Global Impression 'Severity of Illness' (CGI-S) Scale at screening and week 15<br>3. REactive-PROactive Aggression Questionnaire (REPRO) (for parents, teachers, nurses or pedagogical workers) at screening and week 15<br>4. Instrument for Reactive and Proactive Aggression (IRPA) at screening and week 15<br>5. How I Think (HIT) questionnaire at screening and week 15<br>6. Social Support Questionnaire (SSQ) at screening and week 15<br>7. Socio-moral Reflection Objective Measure-Short Form (SROM-OSF) at screening and week 15<br>8. Inventory of callous-unemotional traits (ICU) at screening and week 15<br>9. Reactive-Proactive Aggression Questionnaire (RPQ) (for youths) at screening and week 15