Trial document




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  DRKS00013456

Trial Description

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Title

Evaluation of a web-assisted self-help programme for parents of children with attentiondeficit-/hyperaktivity disorder

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Trial Acronym

WASH

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URL of the Trial

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Brief Summary in Lay Language

The study will examine whether the newly developed web-assisted self-help program for parents of children with ADHD helps to reduce ADHD symptoms and oppositional behavior.
Written parent-self-help programs of the same working group have already proved to be effective and form the basis for this new format of web-assisted self-help.
Participating parents are assigned by chance to one of three offers:
1. Care provided by the pediatrician + access to the web-assisted parent-self-help (WASH) + Additional telephone consultation
2. Care provided by the pediatrician + access to the web-assisted parent-self-help (Wash)
3. Care provided by the pediatrician
The study can include parents of children aged 6 to 12 years with (suspicion) diagnosis of ADHD in which a mental handicap or autism spectrum disorder can be excluded and no indication of inpatient treatment is present.
The study is intended to check the immediate and long-term effects of the use of the web-assisted parent-self-help on the ADHD symptoms /oppositional symptoms of the child in comparison with routine pediatric care. The investigation also aims on showing whether these effects can be increased by providing additional telephone applied support. In comparison with a study, which examines outpatient psychotherapy (BT) in children with comparable symptoms, it is to be checked whether the efficacy of individual outpatient psychotherapy (VT) in a group of children with comparable In-/Exclusion Criteria show superior efficacy to web-assisted self-help (wash) plus telephone-applied psychotherapeutic support.
It is believed that offers with access to the web-assisted parents-self-help compared to routine pediatric care can achieve stronger improvements. It is also assumed that the efficacy of self-help can be increased by telephone consultation. In addition, it is assumed that individual psychotherapeutic care (in addition to routine medical care) is superior to the combination of self-help and telephone applied support.

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Brief Summary in Scientific Language

Main purpose
Investigating the effectiveness of a newly developed web-assisted self-help program (WASH) for parents of children with ADHD aiming on decreasing ADHD symptoms and oppositional behavior problems in order to estimate the potential contribution to improving the supply of Children with ADHD in statutory health insurance.
Background
The web-assisted parents-self-help-program (ADHD-parent trainer) by Döpfner & -Schürmann was developed in cooperation on behalf of the AOK-Bundesverband based on evidence-based written parent self-help programs (parents' booklets and working materials)
Method
Investigation of the effectiveness of the intervention via a randomized three armed parallel groups design:
1. Web-assisted self-help (wash) with psychotherapeutic support (support) applied via telephone including pediatric routine therapy (treatment as usual, tau): WASH + SUPPORT + TAU
2. Web-assisted self-help (WASH) including pediatric routine therapy (TAU): Wash + Tau
3. Pediatric routine therapy (treatment as usual): TAU.
In-/Exclusion-Criteria
IN: Parents of children aged 6; 0 to 12; 11 years with (suspicion) diagnosis of ADHD and/or oppositional behavioral problems;
EX: Children with a mental handicap or autism spectrum disorder, indication for a stationary treatment
Objectives
1. Are there Immediate and long-term effects on external symptoms (combined ADHD/oppositional symptoms) of the child of the use of the ADHD-parent-training compared to routine pediatric therapy? Can these effects be increased by the additional offer of telephone-applied psychotherapeutic support?
2. Does the efficacy of individual outpatient psychotherapy (VT) in a group (not randomized but "matched") of children with comparable In-/Exclusion Criteria show superior efficacy to web-assisted self-help (wash) plus telephone-applied psychotherapeutic support?
Hypotheses
1. Review of efficacy and stability (reduction of external symptoms) of web -assisted parent
Self-help (WASH) and additional telephone support (wash + support) compared to treatment as usual (tau) as control in the randomized, Three armed parallel group design. Main hypothesis: (Wash + support + Tau) > (wash + Tau) > (TAU), ">" means "better effective".
2. Comparison of the efficacy of web-assisted parent-self-help with support (Wash + support) with a classical behavioral therapy with direct contact (VT) in a non-randomized group comparison. Main hypothesis: (vt + Tau) > (wash + support + tau).

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Organizational Data

  •   DRKS00013456
  •   2018/01/03
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  •   yes
  •   Approved
  •   17-273, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1205-6181 
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Health Condition or Problem studied

  •   F90 -  Hyperkinetic disorders
  •   oppositional behavior problems
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Interventions/Observational Groups

  •   pediatric routine care (no restriction of other treatment options, documentation within assessment points) plus link to web-based self-help for parents plus telephone applied support (Interventional Condition 1)
  •   pediatric routine care (no restriction of other treatment options, documentation within assessment Points) plus link to web-based self-help for parents (Interventional Condition 2)
  •   pediatric routine care (no restriction of other treatment options, documentation within assessment points; Routine-Care Control Condition)
  •   Children (meeting comparable in- and exclusion-criteria and assessment tools) receiving individual outpatient psychotherapy (CBT) within 6 months (no restriction of other treatment optioptions, documentation within assessment points; interval to be compared: pretest to 6 months later; Active Controll Condition)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group), Historical, Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Blinded clinical assessment of the child's ADHD symptoms and oppositional symptoms based on recorded semi-structured clinical interview with a parent conducted by telephone (DISYPS III-Diagnostic Checklist ADHD/oppositional behavior using the Interview Guideline) 3, 6 and 18 months after Pretest.

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Secondary Outcome

(1) Child's symptoms in parental assessment(DISYSPS III-third-party assessment form ADHD/SSV)
(2) psychosocial impairment and quality of life of the child (DISYSPS III-third-party assessments ADHD/SSV, Functional-Impairment-Scale; KIDSCREEN: Quality of life)
(3) Comorbid mental symptoms of the child (Child behavior Checklist CBCL/6-18R)
(4) Acceptance of the Offer (yes/no)
(5) Use of the online system (e.g. duration, frequency, scope)
(6) Satisfaction of the parents and pediatritian with the offer (via questionnaire) 3, 6 and 18 months after Pretest;
(7) health-care-cost-diary during 12 months (6th to 18th month after pretest).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/12/15
  •   495
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Arm 1-3: parents of childrean aged 6 to 12 with a (suspicion) diagnosis of ADHD and/ or oppositional bahaviour Problems; Arm 4: children (comparable in-/exclusion-criteria as Arm 1-3) receiving 6 months of outpatient psychotherapy.

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Exclusion Criteria

mental handicap or autism spectrum disorder of the child assessed by the pediatritian; indication for inpatient Treatment of the child

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Addresses

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    • Uniklinik Köln, Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie (AKIP)
    • Mr.  Univ.-Prof. Dr.  Manfred  Döpfner 
    • Pohligstr. 9
    • 50969  Köln
    • Germany
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    • Uniklinik Köln, Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie (AKIP)
    • Ms.  PD Dr.  Julia  Plück 
    • Pohligstraße 9
    • 50969  Köln
    • Germany
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    • Uniklinik Köln, Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie (AKIP)
    • Ms.  PD Dr.  Julia  Plück 
    • Pohligstraße 9
    • 50969  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim G-BA
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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