Treatment of Children With Peer Related Aggressive Behavior

Status Completed

Clinical Trial Summary

The efficacy of the Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a social competence training delivered in an individual format will be evaluated in a randomized controlled trial with children aged 6 to 12 years with peer-related aggressive behaviour.

Clinical Trial Description

The German Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) aims at the therapy of children aged 6 to 12 years with peer-related aggressive behaviour, which results in a persistent impairment of the relationships to other children. Contrary to other treatment approaches, this intervention aims at the individual treatment of problem maintaining and moderating factors of aggressive behaviour. Depending on the individual problem maintaining factors the treatment aims to modify social cognitive information processing, impulse control, social problem solving, social skills and social interactions. Methods: The efficacy will be tested in a partial randomized control group design with n=100 children. N=60 children will be treated for about half a year with the modules of THAV in weekly sessions. The control group of n=40 children will receive alternative interventions with group play and techniques to activate resources of the child. These interventions give the children the opportunity to train pro-social interactions. Outcome parameters are aggressive behaviour und comorbid symptoms as well as problem maintaining factors, psychosocial functioning, family burden and treatment satisfaction. Moreover, variables of the treatment process are assessed. Questionnaires, tests and individual problem checklist were used to assess these outcome and process parameters ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Aggression
Attention Deficit and Disruptive Behavior Disorders
Oppositional Defiant Disorder

Clinical Trial Details

NCT number	NCT01406067
Study type	Interventional
Source	University of Cologne
Contact
Status	Completed
Phase	Phase 3
Start date	January 2011
Completion date	September 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.