Treatment of Children With Peer Related Aggressive Behavior

NCT01406067 | Completed Phase 3

• 1 other identifier: THAV-Study 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Oppositional Defiant Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression

  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- assessment to post assessment 30 weeks after treatment begin and to follow up 3 months and 9 months after post assessment

Secondary Outcomes (8)

• Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating

  change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment

• 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 assessment

• Change in KINDL rating scale for quality of life

  change form pre assessment to post assessment 30 weeks after treatment begin

• Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)

  change form pre assessment to post assessment 30 weeks after treatment begin

• Change in Individual Problem Checklist (IPC)

  change form pre assessment to post assessment 30 weeks after treatment begin

Study Arms (2)

Social Skills Training

EXPERIMENTAL

Behavioral: Treatment Program for Children with Aggressive Behavior

Play group

ACTIVE COMPARATOR

Behavioral: Play group

Interventions

Treatment Program for Children with Aggressive Behavior 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.

Social Skills Training

Play group 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.

Play group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• other disorder is dominating
• other active psychotherapy
• severe mental disorder of the parents

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Department of Child and Adolescent Psychiatry at the University Cologne

Cologne, D-50931, Germany

Location

Related Publications (1)

• 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.

  PMID: 29347904 DERIVED

MeSH Terms

Conditions

Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Anja Goertz-Dorten, PhD

  Department of Child and Adolescent Psychiatry Univ. Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manfred Doepfner, Prof. Dr.

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 29, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

DE (1)