Oppositional Defiant DisorderPhase 3NCT01406067
Treatment of Children With Peer Related Aggressive Behavior
A Phase 3 study testing Treatment Program for Children with Aggressive Behavior and Play group in people with Oppositional Defiant Disorder, run by University of Cologne at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Oppositional Defiant Disorder
- What is being tested?
- Treatment Program for Children with Aggressive Behavior and Play group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- other disorder is dominating
- other active psychotherapy
- severe mental disorder of the parents
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry at the University Cologne
Cologne, D-50931
About this study
Official title: Treatment of Children With Peer Related Aggressive Behavior With the Treatment Programme THAV - a Randomized Controlled Trial
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.
Read the 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
- Conditions
- Oppositional Defiant Disorder
- Being tested
- Treatment Program for Children with Aggressive Behavior, Play group
- Keywords
- social skills training,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial
- Medical subject headings
- Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Program for Children with Aggressive BehaviorBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Skills Training | Experimental | Not described Receives: Behavioral: Treatment Program for Children with Aggressive Behavior |
| Play group | Active comparator | Not described Receives: Behavioral: Play group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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)
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
Measured: 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
The KINDL is a German parent and patient rating scale for the assessment of different aspects of QoL
Measured: change form pre assessment to post assessment 30 weeks after treatment begin
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.
Measured: change form pre assessment to post assessment 30 weeks after treatment begin
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.
Measured: change form pre assessment to post assessment 30 weeks after treatment begin
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.
Measured: change form pre assessment to post assessment 30 weeks after treatment begin
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.
Measured: change form pre assessment to post assessment 30 weeks after treatment begin
Change in Depression Anxiety and Stress Questionnaire (DASS)
The DASS assesses parental depression anxiety and stress
Measured: change form pre assessment to post assessment 30 weeks after treatment begin and follow up 3 months and 9 months after post assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oppositional Defiant DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred Doepfner, University of Cologne
- Investigators
- Anja Goertz-Dorten, PhD, Principal investigator, Department of Child and Adolescent Psychiatry Univ. Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406067
- Sponsor's protocol ID
- THAV-Study 1
- Status last verified
- Apr 2014
- First submitted
- 26 Jul 2011
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29347904
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Children With Peer Related Aggressive Behavior With the Treatment Programme THAV - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01406067
- Acronym / sponsor ID
- THAV-Study 1
- Conditions
- Oppositional Defiant Disorder
- Keywords
- social skills training,, social competence training,, Oppositional Defiant Disorder, peer related aggressive behavior, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Skills Training | Experimental | Behavioral: Treatment Program for Children with Aggressive Behavior |
| Play group | Active comparator | Behavioral: Play group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- other disorder is dominating
- other active psychotherapy
- severe mental disorder of the parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Program for Children with Aggressive Behavior24 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. | Behavioural | Social Skills Training |
| Play group12 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. | Behavioural | Play group |
Primary outcome
Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression
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
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
8 secondary outcomes
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent and teacher rating
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
Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)
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
Change in KINDL rating scale for quality of life
Time frame: change form pre assessment to post assessment 30 weeks after treatment begin
Change in Modified WFIRS (Weiss Functional Impairment Rating Scale)
Time frame: change form pre assessment to post assessment 30 weeks after treatment begin
Change in Individual Problem Checklist (IPC)
Time frame: change form pre assessment to post assessment 30 weeks after treatment begin
Change in Social Problem Solving Test (SPST)
Time frame: change form pre assessment to post assessment 30 weeks after treatment begin
Change in Five minutes speech sample (FMSS)
Time frame: change form pre assessment to post assessment 30 weeks after treatment begin
Change in Depression Anxiety and Stress Questionnaire (DASS)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Derived from this study: PubMed 29347904Katzmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Goertz-Dorten, PhD principal investigator
Department of Child and Adolescent Psychiatry Univ. Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment Program for Children with Aggressive Behavior and Play group in people with Oppositional Defiant Disorder, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Questionnaire for Aggressive Behavior of Children (FAVK) total score for peer related aggression (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01406067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.