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Treatment of Children With Peer Related Aggressive Behavior (ScouT)

Primary Purpose

Oppositional Defiant Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Social Skills Training
Treatment Program with techniques to activate resources
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder focused on measuring social skills training,, computer based,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Child and Adolescent Psychiatry at the University CologneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social Skills Training

Treatment Program with techniques to activate resources

Arm Description

Social Skills Training child-focused and subsequent social competence training which combines patient- and parent-/teacher and peer-focused interventions

Treatment Program with techniques to activate resources of the child and subsequent Social Skills Training child-focused

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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
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.
FABEL rating scale for family burden
The Modified FABEL is a parent rating scale for the assessment of different aspects of Family burden
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
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.
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.
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.
Depression Anxiety and Stress Questionnaire (DASS)
The DASS assesses parental depression anxiety and stress

Full Information

First Posted
May 18, 2014
Last Updated
March 14, 2017
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02143427
Brief Title
Treatment of Children With Peer Related Aggressive Behavior (ScouT)
Official Title
Treatment of Children With Peer Related Aggressive Behavior With the Computer Based Treatment Program ScouT - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder
Keywords
social skills training,, computer based,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Skills Training
Arm Type
Experimental
Arm Description
Social Skills Training child-focused and subsequent social competence training which combines patient- and parent-/teacher and peer-focused interventions
Arm Title
Treatment Program with techniques to activate resources
Arm Type
Active Comparator
Arm Description
Treatment Program with techniques to activate resources of the child and subsequent Social Skills Training child-focused
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Treatment Program with techniques to activate resources
Intervention Description
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
Primary Outcome Measure Information:
Title
total score for peer related aggression in the Questionnaire for Aggressive Behavior of Children (FAVK) parent rating
Description
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.
Time Frame
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 Measure Information:
Title
total score for peer related aggression in the Questionnaire for Aggressive Behavior of Children (FAVK) teacher rating, patient self-report
Description
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.
Time Frame
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)
Title
ODD-Score of the Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent, teacher and patient self-report
Description
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.
Time Frame
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)
Title
ODD-Score of the Diagnostic Checklist for Oppositional Defiant and Conduct Disorder (DCL-SSV)
Description
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.
Time Frame
change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
Title
Externalizing Problems Score of the Child Behavior Checklist (CBCL), the Teacher Report Form (TRF), and the Youth Self-Report (YSR)
Description
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.
Time Frame
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)
Title
Internalizing Problems Score of the Child Behavior Checklist (CBCL) and the Teacher Report Form (TRF) , and the Youth Self-Report (YSR)
Description
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.
Time Frame
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)
Title
ADHD Symptom Checklist (FBB-ADHS) ,report parent, teacher and patient self-report ADHD Symptom Checklist (FBB-ADHS)
Description
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.
Time Frame
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)
Title
ICU (Inventory of Callous-Unemotional Traits)
Description
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
Time Frame
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)
Title
KINDL rating scale for quality of life, parent and patient self-report
Description
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.
Time Frame
change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
Title
FABEL rating scale for family burden
Description
The Modified FABEL is a parent rating scale for the assessment of different aspects of Family burden
Time Frame
change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
Title
Harter rating scale for self-concept
Description
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
Time Frame
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)
Title
Modified WFIRS (Weiss Functional Impairment Rating Scale)
Description
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.
Time Frame
change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
Title
Individual Problem Checklist (IPC)
Description
The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.
Time Frame
change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
Title
ScouT-Social Problem Solving Test (ScouT-SPST)
Description
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.
Time Frame
change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
Title
Depression Anxiety and Stress Questionnaire (DASS)
Description
The DASS assesses parental depression anxiety and stress
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Goertz-Dorten, PhD
Email
diplpsychgoertz@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Goertz-Dorten, PhD
Organizational Affiliation
Department of Child and Adolescent Psychiatry Univ. Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry at the University Cologne
City
Cologne
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35398192
Citation
Goertz-Dorten A, Dose C, Hofmann L, Katzmann J, Groth M, Detering K, Hellmann A, Stadler L, Braun B, Hellmich M, Doepfner M. Effects of Computer-Assisted Social Skills Training in Children With Disruptive Behavior Disorders: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1329-1340. doi: 10.1016/j.jaac.2022.03.027. Epub 2022 Apr 6.
Results Reference
derived

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Treatment of Children With Peer Related Aggressive Behavior (ScouT)

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