Treatment of Children With Peer Related Aggressive Behavior

Oppositional Defiant Disorder Clinical Trial

Official title:

Treatment of Children With Peer Related Aggressive Behavior With the Treatment Programme THAV - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406067
• Other study ID #: THAV-Study 1
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2011
• Last updated: April 14, 2014
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age: 6 - 12 years

• IQ>= 80

• Diagnoses (ICD-10): F91, F92, F90.1

• high symptom score in the parent rated Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) (Stanine = 7) at assessment 1 and assessment 2

• Often conflicts with other children (clinical rating)

• Impaired social relationships / activities

• Parents agree in randomization

• in medicated children no planned change of the medication

Exclusion Criteria:

• other disorder is dominating

• other active psychotherapy

• severe mental disorder of the parents

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

Intervention

Behavioral:
• Treatment Program for Children with Aggressive Behavior
24 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 10 sessions with relatives of the child in most cases with the parents.
• Play group
12 double sessions (totally 24 treatment hours) in groups with up to 5 children. Different play activities were presented including techniques to activate resources of the child. These interventions give the children the opportunity to train pro-social interactions. Additionally up to 3 parent sessions were also included.

Locations

Country	Name	City	State
Germany	Department of Child and Adolescent Psychiatry at the University Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression	The Questionnaire for Aggressive Behavior of Children (FAVK) is a newly developed parent rating scale which assesses several factors of peer related aggression: (1) disturbance of social cognitive information processing, (2) disturbance of social problem solving and social skills, (3) disturbance of impulse control, and (4) disturbance of social interaction. These scores a summed to a total score	Change from pre- assessment to post assessment 30 weeks after treatment begin and to follow up 3 months and 9 months after post assessment	No
Secondary	Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating	The Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) assesses all symptom criteria for ODD and some of the symptom criteria of Conduct Disorders according to ICD-10 and DSM-IV.	change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment	No
Secondary	Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)	The CBCL and the TRF are well evaluated rating scales for the assessement of a broad spectrum of child behavioral and emotional problems as perceived by parents and teachers respectively	change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment	No
Secondary	Change in KINDL rating scale for quality of life	The KINDL is a German parent and patient rating scale for the assessment of different aspects of QoL	change form pre assessment to post assessment 30 weeks after treatment begin	No
Secondary	Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)	The modified WFIRS is a parent rating scale for the assessment of psychosocial functioning in children with ODD/CD. The original WFIRS has been developed to assess psychosocial functioning in children with ADHD. Several items have been adapted or deleted in thise modified version.	change form pre assessment to post assessment 30 weeks after treatment begin	No
Secondary	Change in Individual Problem Checklist (IPC)	The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.	change form pre assessment to post assessment 30 weeks after treatment begin	No
Secondary	Change in Social Problem Solving Test (SPST)	The Social Problem Solving Test (SPST) is a newly developed test that assesses problem solving compentecies according to the social problem solving theory of Kenneth Dodge as well as behavioural tendencies in specific conflict situations.	change form pre assessment to post assessment 30 weeks after treatment begin	No
Secondary	Change in Five minutes speech sample (FMSS)	The FMSS is a standard assessment procedure to assess negative expressed emotions within the family. The parents are asked to describe their child for five minutes. The recorded descriptions were analyzed according to several domains.	change form pre assessment to post assessment 30 weeks after treatment begin	No
Secondary	Change in Depression Anxiety and Stress Questionnaire (DASS)	The DASS assesses parental depression anxiety and stress	change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment	No