Treatment of Children With Peer Related Aggressive Behavior (ScouT)

Study Overview
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Brief Summary
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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.

Detailed Description
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The German computer based Treatment Program for Children with Aggressive Behaviour (Soziales computerunterstütztes Training für Kinder mit aggressivem Verhalten, ScouT) 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, social problem solving and behavioral social skills. Methods: The efficacy will be tested in a randomized control group design with n=140 children. N=70 children will be treated in the first treatment phase (pre- to post1-assessment) of 16 weekly child-focused sessions with the treatment modules of ScouT. In the second treatment phase (post1- to post2- assessment) those children with sustained severe peer related aggressive behavior receive the comprehensive Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a social competence training which combines patient- and parent-/teacher and peer-focused interventions with 16 child sessions and 6 parent-/teacher sessions. Those children with no severe peer related aggressive behavior receive 2 booster sessions of ScouT within a 16 week period. The control group of n=70 children will receive in the first treatment phase (pre- to post1-assessment) an alternative child-focused intervention with a supportive Treatment Programm including techniques to activate resources of the child (Supportive Therapie zur Aktivierung von Ressourcen bei Kindern, STARK) with 16 weekly sessions. In the second treatment phase (post1- to post2- assessment) those children with sustained severe peer related aggressive behavior receive 16 weekly child-focused sessions with the treatment modules of ScouT . Those children with no severe peer related aggressive behavior receive 2 booster sessions of STARK within a 16 week period. A follow-up assessment is conducted 12 months after post2-assessment. Outcome parameters are aggressive behaviour und comorbid symptoms as well as problem maintaining factors, psychosocial functioning, family burden, self-esteem and treatment satisfaction as rated by clinicians, parents, or teachers. Additionally problem solving is assessed by a newly developed problem-solving test. Moreover, variables of the treatment process are assessed. Additionally treatment process parameters are assessed.

Official Title
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Treatment of Children With Peer Related Aggressive Behavior With the Computer Based Treatment Program ScouT - a Randomized Controlled Trial

Conditions
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Oppositional Defiant Disorder

Intervention / Treatment
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* Behavioral: Social Skills Training
* Behavioral: Treatment Program with techniques to activate resources


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Skills Training<br>Social Skills Training child-focused and subsequent social competence training which combines patient- and parent-/teacher and peer-focused interventions | Behavioral: Social Skills Training<br>* Behavioral: computer-based Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 2 sessions with relatives of the child in most cases with the parents and subsequent Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 6 sessions with relatives of the child in most cases with the parents. Arms: Social Skills Training<br>|
| Active Comparator: Treatment Program with techniques to activate resources<br>Treatment Program with techniques to activate resources of the child and subsequent Social Skills Training child-focused | Behavioral: Treatment Program with techniques to activate resources<br>* Behavioral: Treatment Program with techniques to activate resources 16 sessions with the child aiming at the reduction of peer related aggressive behavior via activate resources. Additionally up to 2 sessions with relatives of the child in most cases with the parents and subsequent computer based Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Arms: Treatment Program with techniques to activate resources of the child and subsequent Social Skills Training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social skills training,, computer based,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial