Oppositional Defiant Disorder Clinical Trial
Official title:
Treatment of Children With Peer Related Aggressive Behavior With the Computer Based Treatment Program ScouT - a Randomized Controlled Trial
The efficacy of the computer based Treatment Program for Children with Aggressive Behaviour (Soziales computerunterstütztes Training für Kinder mit aggressivem Verhalten, ScouT) which is a child focused 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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | September 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Age: 6 - 12 years - IQ>= 80 - Diagnoses (ICD-10): F91, F92, F90.1 - Elevated symptom score in the parent rated Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) with Stanine = 7 at pre-assessment - Often conflicts with other children (clinical rating) - Impaired social relationships / activities - Parents agree in randomization (clinical rating) in medicated children no planned change of the medication Exclusion Criteria: - Other disorder is dominating - Other active psychotherapy - Severe mental disorder of the parents |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Child and Adolescent Psychiatry at the University Cologne | Cologne |
Lead Sponsor | Collaborator |
---|---|
University of Cologne |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total score for peer related aggression in the Questionnaire for Aggressive Behavior of Children (FAVK) parent rating | 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- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | total score for peer related aggression in the Questionnaire for Aggressive Behavior of Children (FAVK) teacher rating, patient self-report | 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. Self-report is assessed in children aged 9 or older. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | ODD-Score of the Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent, teacher and patient self-report | 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. Self-report is assessed in children aged 11 or older. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | ODD-Score of the Diagnostic Checklist for Oppositional Defiant and Conduct Disorder (DCL-SSV) | The Diagnostic Checklist for Oppositional Defiant and Conduct Disorder (DCL-SSV) is rated by a (blinded) clinician and assesses all symptom criteria for ODD and some of the symptom criteria of Conduct Disorders according to ICD-10 and DSM-IV based on parent information in a semi-structured interview. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment) | |
Secondary | Externalizing Problems Score of the Child Behavior Checklist (CBCL), the Teacher Report Form (TRF), and the Youth Self-Report (YSR) | The CBCL, TRF and YSR are well evaluated rating scales for the assessment of a broad spectrum of child behavioral and emotional problems as perceived by parents and teachers respectively. Self-report is assessed in children aged 11 or older. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | Internalizing Problems Score of the Child Behavior Checklist (CBCL) and the Teacher Report Form (TRF) , and the Youth Self-Report (YSR) | The CBCL, TRF, and YSR are well evaluated rating scales for the assessment of a broad spectrum of child behavioral and emotional problems as perceived by parents and teachers respectively. Self-report is assessed in children aged 11 or older. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | ADHD Symptom Checklist (FBB-ADHS) ,report parent, teacher and patient self-report ADHD Symptom Checklist (FBB-ADHS) | ADHD Symptom Checklist (FBB-ADHS) assesses all symptom criteria for ADHD according to ICD-10 and DSM-IV. Self-report is assessed in children aged 11 or older. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | ICU (Inventory of Callous-Unemotional Traits) | The ICU is designed to assess CU traits using self- and parent -report. The ICU consists of three subscales: Callousness, Uncaring and Unemotional. Self-report is assessed in children aged 9 or older | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | KINDL rating scale for quality of life, parent and patient self-report | The KINDL is a German parent and patient rating scale for the assessment of different aspects of QoL. Self-report is assessed in children aged 7 or older. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment) | |
Secondary | FABEL rating scale for family burden | The Modified FABEL is a parent rating scale for the assessment of different aspects of Family burden | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment) | |
Secondary | Harter rating scale for self-concept | The Modified Harter scale is a self rating scale for the assessment of different aspects of self-concept. Self-report is assessed in children aged 9 or older | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) | |
Secondary | 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 this modified version. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment) | |
Secondary | 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 from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment) | |
Secondary | ScouT-Social Problem Solving Test (ScouT-SPST) | The ScouT-Social Problem Solving Test (ScouT-SPST) is a test that assesses problem solving compentecies according to the social problem solving theory (Dodge) as well as behavioural tendencies in specific conflict situations. | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment) | |
Secondary | Depression Anxiety and Stress Questionnaire (DASS) | The DASS assesses parental depression anxiety and stress | change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment) |
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