Treatment of Children With Peer Related Aggressive Behavior
Primary Purpose
Oppositional Defiant Disorder
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Treatment Program for Children with Aggressive Behavior
Play group
Sponsored by
About this trial
This is an interventional treatment trial for Oppositional Defiant Disorder focused on measuring social skills training,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial
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
Sites / Locations
- Department of Child and Adolescent Psychiatry at the University Cologne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Social Skills Training
Play group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating
The 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 Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)
The 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 life
The 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)
The 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 Individual Problem Checklist (IPC)
The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.
Change in Social Problem Solving Test (SPST)
The 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)
The 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)
The DASS assesses parental depression anxiety and stress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01406067
Brief Title
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
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder
Keywords
social skills training,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social Skills Training
Arm Type
Experimental
Arm Title
Play group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Treatment Program for Children with Aggressive Behavior
Intervention Description
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
Intervention Name(s)
Play group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression
Description
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
Time Frame
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 Outcome Measure Information:
Title
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating
Description
The 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.
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment
Title
Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)
Description
The 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
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment
Title
Change in KINDL rating scale for quality of life
Description
The KINDL is a German parent and patient rating scale for the assessment of different aspects of QoL
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin
Title
Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)
Description
The 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.
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin
Title
Change in Individual Problem Checklist (IPC)
Description
The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin
Title
Change in Social Problem Solving Test (SPST)
Description
The 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.
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin
Title
Change in Five minutes speech sample (FMSS)
Description
The 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.
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin
Title
Change in Depression Anxiety and Stress Questionnaire (DASS)
Description
The DASS assesses parental depression anxiety and stress
Time Frame
change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Goertz-Dorten, PhD
Organizational Affiliation
Department of Child and Adolescent Psychiatry Univ. Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry at the University Cologne
City
Cologne
ZIP/Postal Code
D-50931
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29347904
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.
Results Reference
derived
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Treatment of Children With Peer Related Aggressive Behavior
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