Treatment of Children With Peer Related Aggressive Behavior (ScouT)

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02143427
• Other study ID #: ScouT-Study 1
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2014
• Last updated: March 14, 2017
• Start date: May 2014
• Est. completion date: September 2017

Study information

• Verified date: February 2017
• Source: University of Cologne
• Contact: Anja Goertz-Dorten, PhD
• Email: diplpsychgoertz[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aggression
• Attention Deficit and Disruptive Behavior Disorders
• Oppositional Defiant Disorder

Intervention

Behavioral:
• Social Skills Training
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
• Treatment Program with techniques to activate resources
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

Locations

Country	Name	City	State
Germany	Department of Child and Adolescent Psychiatry at the University Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

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)