Clinical trial NCT01406067: Treatment of Children With Peer Related Aggressive Behavior
Official title: Treatment of Children With Peer Related Aggressive Behavior With the Treatment Programme THAV - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oppositional Defiant Disorder
Keywords: social skills training,
social competence training,
Oppositional Defiant Disorder
peer related aggressive behavior
randomized controlled trial
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 100
Sex: MALE
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 Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a 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 Treatment Program for Children with Aggressive Behaviour (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) 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, impulse control, social problem solving, social skills and social interactions. Methods: The efficacy will be tested in a partial randomized control group design with n=100 children. N=60 children will be treated for about half a year with the modules of THAV in weekly sessions. The control group of n=40 children will receive alternative interventions with group play and techniques to activate resources of the child. These interventions give the children the opportunity to train pro-social interactions. Outcome parameters are aggressive behaviour und comorbid symptoms as well as problem maintaining factors, psychosocial functioning, family burden and treatment satisfaction. Moreover, variables of the treatment process are assessed. Questionnaires, tests and individual problem checklist were used to assess these outcome and process parameters

Eligibility criteria: Inclusion Criteria:

* Age: 6 - 12 years
* IQ\>= 80
* Diagnoses (ICD-10): F91, F92, F90.1
* high symptom score in the parent rated Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) (Stanine ≥ 7) at assessment 1 and assessment 2
* Often conflicts with other children (clinical rating)
* Impaired social relationships / activities
* Parents agree in randomization
* 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: Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression
timeFrame: Change from pre- assessment to post assessment 30 weeks after treatment begin and to follow up 3 months and 9 months after post assessment
Secondary outcomes:
measure: Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment
measure: Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment
measure: Change in KINDL rating scale for quality of life
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin
measure: Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin
measure: Change in Individual Problem Checklist (IPC)
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin
measure: Change in Social Problem Solving Test (SPST)
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin
measure: Change in Five minutes speech sample (FMSS)
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin
measure: Change in Depression Anxiety and Stress Questionnaire (DASS)
timeFrame: change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post 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: Katzmann J, Goertz-Dorten A, Hautmann C, Doepfner M. Social skills training and play group intervention for children with oppositional-defiant disorders/conduct disorder: Mediating mechanisms in a head-to-head comparison. Psychother Res. 2019 Aug;29(6):784-798. doi: 10.1080/10503307.2018.1425559. Epub 2018 Jan 19.