Treatment of Children With Peer Related Aggressive Behavior

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manfred Doepfner, University of Cologne
ClinicalTrials.gov Identifier:
NCT01406067
First received: July 26, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Oppositional Defiant Disorder
Behavioral: Treatment Program for Children with Aggressive Behavior
Behavioral: Play group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Children With Peer Related Aggressive Behavior With the Treatment Programme THAV - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression [ Time Frame: Change from pre- assessment to post assessment 30 weeks after treatment begin and to follow up 3 months and 9 months after post assessment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment ] [ Designated as safety issue: No ]
    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 in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF) [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment ] [ Designated as safety issue: No ]
    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 in KINDL rating scale for quality of life [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin ] [ Designated as safety issue: No ]
    The KINDL is a German parent and patient rating scale for the assessment of different aspects of QoL

  • Change in Modified WFIRS (Weiss Functional Impairment Rating Scale) [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin ] [ Designated as safety issue: No ]
    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 in Individual Problem Checklist (IPC) [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin ] [ Designated as safety issue: No ]
    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 in Social Problem Solving Test (SPST) [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin ] [ Designated as safety issue: No ]
    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 in Five minutes speech sample (FMSS) [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin ] [ Designated as safety issue: No ]
    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 in Depression Anxiety and Stress Questionnaire (DASS) [ Time Frame: change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment ] [ Designated as safety issue: No ]
    The DASS assesses parental depression anxiety and stress


Estimated Enrollment: 100
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social Skills Training 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.
Active Comparator: Play group Behavioral: 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.

Detailed 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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406067

Locations
Germany
Department of Child and Adolescent Psychiatry at the University Cologne
Cologne, Germany, D-50931
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Anja Goertz-Dorten, PhD Department of Child and Adolescent Psychiatry Univ. Cologne
  More Information

No publications provided

Responsible Party: Manfred Doepfner, Manfred Doepfner, Prof. Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT01406067     History of Changes
Other Study ID Numbers: THAV-Study 1
Study First Received: July 26, 2011
Last Updated: April 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
social skills training,
social competence training,
Oppositional Defiant Disorder
peer related aggressive behavior
randomized controlled trial

Additional relevant MeSH terms:
Aggression
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on October 20, 2014