Treatment of Children With Peer Related Aggressive Behavior

NCT ID: NCT01406067

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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

Conditions

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Oppositional Defiant Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Social Skills Training

Group Type EXPERIMENTAL

Treatment Program for Children with Aggressive Behavior

Intervention Type BEHAVIORAL

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.

Play group

Group Type ACTIVE_COMPARATOR

Play group

Intervention Type BEHAVIORAL

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.

Interventions

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Treatment 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.

Intervention Type BEHAVIORAL

Play 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Manfred Doepfner

Manfred Doepfner, Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anja Goertz-Dorten, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Child and Adolescent Psychiatry Univ. Cologne

Locations

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Department of Child and Adolescent Psychiatry at the University Cologne

Cologne, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29347904 (View on PubMed)

Other Identifiers

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THAV-Study 1

Identifier Type: -

Identifier Source: org_study_id

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