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Treatment of Children With Peer Related Aggressive Behavior

Treatment of Children With Peer Related Aggressive Behavior With the Treatment Programme THAV - a Randomized Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01406067
Enrollment
100
Registered
2011-07-29
Start date
2011-01-31
Completion date
2013-09-30
Last updated
2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oppositional Defiant Disorder

Keywords

social skills training,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial

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

Interventions

BEHAVIORALTreatment Program for Children with Aggressive Behavior

24 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 10 sessions with relatives of the child in most cases with the parents.

BEHAVIORALPlay group

12 double sessions (totally 24 treatment hours) in groups with up to 5 children. Different play activities were presented including techniques to activate resources of the child. These interventions give the children the opportunity to train pro-social interactions. Additionally up to 3 parent sessions were also included.

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggressionChange from pre- assessment to post assessment 30 weeks after treatment begin and to follow up 3 months and 9 months after post assessmentThe 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

MeasureTime frameDescription
Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessmentThe CBCL and the TRF are well evaluated rating scales for the assessement of a broad spectrum of child behavioral and emotional problems as perceived by parents and teachers respectively
Change in KINDL rating scale for quality of lifechange form pre assessment to post assessment 30 weeks after treatment beginThe KINDL is a German parent and patient rating scale for the assessment of different aspects of QoL
Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)change form pre assessment to post assessment 30 weeks after treatment beginThe 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 thise modified version.
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher ratingchange form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessmentThe 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.
Change in Social Problem Solving Test (SPST)change form pre assessment to post assessment 30 weeks after treatment beginThe Social Problem Solving Test (SPST) is a newly developed test that assesses problem solving compentecies according to the social problem solving theory of Kenneth Dodge as well as behavioural tendencies in specific conflict situations.
Change in Five minutes speech sample (FMSS)change form pre assessment to post assessment 30 weeks after treatment beginThe FMSS is a standard assessment procedure to assess negative expressed emotions within the family. The parents are asked to describe their child for five minutes. The recorded descriptions were analyzed according to several domains.
Change in Depression Anxiety and Stress Questionnaire (DASS)change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessmentThe DASS assesses parental depression anxiety and stress
Change in Individual Problem Checklist (IPC)change form pre assessment to post assessment 30 weeks after treatment beginThe IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026