Clinical trial NCT02143427: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Oppositional Defiant Disorder
Keywords: social skills training,
computer based,
social competence training,
Oppositional Defiant Disorder
peer related aggressive behavior
randomized controlled trial
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: total score for peer related aggression in the Questionnaire for Aggressive Behavior of Children (FAVK) parent rating
timeFrame: 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 outcomes:
measure: total score for peer related aggression in the Questionnaire for Aggressive Behavior of Children (FAVK) teacher rating, patient self-report
timeFrame: 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)
measure: ODD-Score of the Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent, teacher and patient self-report
timeFrame: 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)
measure: ODD-Score of the Diagnostic Checklist for Oppositional Defiant and Conduct Disorder (DCL-SSV)
timeFrame: change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
measure: Externalizing Problems Score of the Child Behavior Checklist (CBCL), the Teacher Report Form (TRF), and the Youth Self-Report (YSR)
timeFrame: 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)
measure: Internalizing Problems Score of the Child Behavior Checklist (CBCL) and the Teacher Report Form (TRF) , and the Youth Self-Report (YSR)
timeFrame: 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)
measure: ADHD Symptom Checklist (FBB-ADHS) ,report parent, teacher and patient self-report ADHD Symptom Checklist (FBB-ADHS)
timeFrame: 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)
measure: ICU (Inventory of Callous-Unemotional Traits)
timeFrame: 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)
measure: KINDL rating scale for quality of life, parent and patient self-report
timeFrame: change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
measure: FABEL rating scale for family burden
timeFrame: change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
measure: Harter rating scale for self-concept
timeFrame: 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)
measure: Modified WFIRS (Weiss Functional Impairment Rating Scale)
timeFrame: change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
measure: Individual Problem Checklist (IPC)
timeFrame: change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
measure: ScouT-Social Problem Solving Test (ScouT-SPST)
timeFrame: change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)
measure: Depression Anxiety and Stress Questionnaire (DASS)
timeFrame: 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)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Child and Adolescent Psychiatry at the University Cologne
Study officials:
affiliation: Department of Child and Adolescent Psychiatry Univ. Cologne
name: Anja Goertz-Dorten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.