Trial document




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  DRKS00014963

Trial Description

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Title

Efficacy of Internet Based Parent Management Training in the Treatment of Afective Dysregulation and Coexisting Conditions in Children

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Trial Acronym

ADOPT online

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URL of the Trial

http://www.adopt-studie.de

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Brief Summary in Lay Language

When children suffer from problems in dealing with negative emotions like anger or sadness we call this Affective Dysregulation. Those children show bursts of anger, persistent irritability, bad temper and sudden mood changes. The aim of this study is to develop an online parent training in which parents learn strategies to solve daily problems with their child and to support their child in dealing with negative emotions. Additionally, we will investigate whether the training helps.

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Brief Summary in Scientific Language

This subproject is embedded into a study consortium that develops and evaluates a stepped intervention for children with Affective Dysregulation at five sites in Germany. In this subproject called ADOPT online, the efficacy of an Online Parent Self-Help of Affective Dysregulation and coexisting disorders (OnPaSH-AD) is to be investigated compared to treatment as usual. The term Affective Dysregulation describes a transdiagnostic dimension and characterizes an excessive reactivity to negative emotional stimuli with an affective (anger) and a behavioral component (aggression). An evaluated online training for parents of children with ADHD will be supplemented with evidence-based interventions for the improvement of emotion regulation. In a randomized control trial the efficacy will be assessed over a reduction of symptoms of affective dysregulation, comorbid conditions, functional impairment and psychosocial wellbeing.

Amendment: Reduction of sample size after renewed power calculation (vote in favour on 22.02.2019)

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Organizational Data

  •   DRKS00014963
  •   2018/06/27
  •   [---]*
  •   yes
  •   Approved
  •   18-033, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F34.8 -  Other persistent mood [affective] disorders
  •   mood dysregulation as transdiagnostic dimension
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Interventions/Observational Groups

  •   Intervention group: online parent training at least one hour weekly for 12 weeks
  •   Treatment as usual: Parents of this group are advised to search for a psychosocial support if wanted (e.g. education counselling, outpatient psychotherapy) or to wait. After a 12 weeks waiting phase they gain access to the online parent training.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Blinded clinician-rated AD (=Affective Dysregulation) symptom score of the child, assessed with a newly developed outcome measure for AD (DADYS interview) based on patient and parent interview at T1-T4

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Secondary Outcome

(1) psychosocial impairment of the child due to AD symptoms based on patient and parent interview (DADYS interview/DADYS questionnaire)
(2) patient- and parent-rated AD symptoms of the child (DADYS questionnaire)
(3) patient- and parent-rated symptoms of ADHD and ODD/CD (SBB-ADHS/-SSV, FBB-ADHS/-SSV)
(4) other comorbid conditions (e.g., anxiety, depression) assessed by parent-ratings (CBCL 6-18R)
(5) psychological well-being in patient- and parent-rating (KIDSCREEN-27)
(6) parental satisfaction with the treatment (self-developed questionnaire)
(1)-(5) will be collected at T1-T4; (6) will be collected at T2

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/07/09
  •   497
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   107   Months
  •   155   Months
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Additional Inclusion Criteria

- Age 8;0 to 12;11 yrs.
- Resident with at least one natural or adoptive parent
- Clinician-rated Outcome Measure for AD (DADYS interview, DADYS questionnaire) > cut-off. The cut-off will be determined by a clinical overall rating of AD at the end of the structured clinical parent interview.
- Willingness and ability of parents to participate in the online intervention (existence of an informed consent of the guardians and an assent of the child)
- Sufficient knowledge of German language

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Exclusion Criteria

- Intelligence <80 (visit to a special school for mental development or to a regular school with funding priority mental development)
- Resident without natural or adoptive parents (e.g. foster parents, grandparents)
- mental disorder other than Coexisting Conditions (CoCo) is primary disorder and main cause of AD (e.g. autism spectrum disorder)
- current or planned intensive behavioral therapy on a weekly/biweekly basis

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Addresses

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    • Universität zu KölnHumanwissenschaftliche FakultätPsychologie und Psychotherapie in Heilpädagogik und Rehabilitation
    • Ms.  Prof. Dr.  Charlotte  Hanisch 
    • Klosterstraße 79b
    • 50931  Köln
    • Germany
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    • Universität zu KölnHumanwissenschaftliche FakultätPsychologie und Psychotherapie in Heilpädagogik und Rehabilitation
    • Ms.  Anne  Ritschel 
    • Klosterstraße 79b
    • 50931  Köln
    • Germany
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    • Universität zu KölnHumanwissenschaftliche FakultätPsychologie und Psychotherapie in Heilpädagogik und Rehabilitation
    • Ms.  Anne  Ritschel 
    • Klosterstraße 79b
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • BMBF
    • 53170  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.