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Completed

NCT Number: NCT01406067

Treatment of Children With Peer Related Aggressive Behavior

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.

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Key information

Conditions

Oppositional Defiant Disorder Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Department of Child and Adolescent Psychiatry at the University Cologne

Cologne, D-50931, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment Program for Children with Aggressive Behavior

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. 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

    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

  3. Change in KINDL rating scale for quality of life

    Time frame: change form pre assessment to post assessment 30 weeks after treatment begin

    The KINDL is a German parent and patient rating scale for the assessment of different aspects of QoL

  4. Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)

    Time frame: change form pre assessment to post assessment 30 weeks after treatment begin

    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.

  5. Change in Individual Problem Checklist (IPC)

    Time frame: change form pre assessment to post assessment 30 weeks after treatment begin

    The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.

  6. Change in Social Problem Solving Test (SPST)

    Time frame: change form pre assessment to post assessment 30 weeks after treatment begin

    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.

  7. Change in Five minutes speech sample (FMSS)

    Time frame: change form pre assessment to post assessment 30 weeks after treatment begin

    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.

  8. 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

    The DASS assesses parental depression anxiety and stress

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2011
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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