NCT02143427

Brief Summary

The efficacy of the computer based Treatment Program for Children with Aggressive Behaviour (Soziales computerunterstütztes Training für Kinder mit aggressivem Verhalten, ScouT) which is a child focused 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 16, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

May 18, 2014

Last Update Submit

March 14, 2017

Conditions

Keywords

social skills training,computer based,social competence training,Oppositional Defiant Disorderpeer related aggressive behaviorrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

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

    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- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment)

Secondary Outcomes (14)

  • total score for peer related aggression in the Questionnaire for Aggressive Behavior of Children (FAVK) teacher rating, patient self-report

    change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment)

  • ODD-Score of the Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent, teacher and patient self-report

    change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment)

  • ODD-Score of the Diagnostic Checklist for Oppositional Defiant and Conduct Disorder (DCL-SSV)

    change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment)

  • Externalizing Problems Score of the Child Behavior Checklist (CBCL), the Teacher Report Form (TRF), and the Youth Self-Report (YSR)

    change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment)

  • Internalizing Problems Score of the Child Behavior Checklist (CBCL) and the Teacher Report Form (TRF) , and the Youth Self-Report (YSR)

    change from pre- to post1-assessment (24 weeks after pre-assessment), from post1- to post2-assessment (16 weeks after post1-assessment), and to follow up (12 months after post2-assessment)

  • +9 more secondary outcomes

Study Arms (2)

Social Skills Training

EXPERIMENTAL

Social Skills Training child-focused and subsequent social competence training which combines patient- and parent-/teacher and peer-focused interventions

Behavioral: Social Skills Training

Treatment Program with techniques to activate resources

ACTIVE COMPARATOR

Treatment Program with techniques to activate resources of the child and subsequent Social Skills Training child-focused

Behavioral: Treatment Program with techniques to activate resources

Interventions

Behavioral: computer-based Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 2 sessions with relatives of the child in most cases with the parents and subsequent Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 6 sessions with relatives of the child in most cases with the parents. Arms: Social Skills Training

Social Skills Training

Behavioral: Treatment Program with techniques to activate resources 16 sessions with the child aiming at the reduction of peer related aggressive behavior via activate resources. Additionally up to 2 sessions with relatives of the child in most cases with the parents and subsequent computer based Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Arms: Treatment Program with techniques to activate resources of the child and subsequent Social Skills Training

Treatment Program with techniques to activate resources

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6 - 12 years
  • IQ\>= 80
  • Diagnoses (ICD-10): F91, F92, F90.1
  • Elevated symptom score in the parent rated Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) with Stanine ≥ 7 at pre-assessment
  • Often conflicts with other children (clinical rating)
  • Impaired social relationships / activities
  • Parents agree in randomization (clinical rating) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child and Adolescent Psychiatry at the University Cologne

Cologne, Germany

RECRUITING

Related Publications (1)

  • Goertz-Dorten A, Dose C, Hofmann L, Katzmann J, Groth M, Detering K, Hellmann A, Stadler L, Braun B, Hellmich M, Doepfner M. Effects of Computer-Assisted Social Skills Training in Children With Disruptive Behavior Disorders: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1329-1340. doi: 10.1016/j.jaac.2022.03.027. Epub 2022 Apr 6.

MeSH Terms

Conditions

Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Anja Goertz-Dorten, PhD

    Department of Child and Adolescent Psychiatry Univ. Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Goertz-Dorten, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anja Goertz-Dorten, PhD

Study Record Dates

First Submitted

May 18, 2014

First Posted

May 21, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

March 16, 2017

Record last verified: 2017-02

Locations