Trial document




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  DRKS00008971

Trial Description

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Title

Evidence-based, stepped care of ADHD in preschool children

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Trial Acronym

ESCApreschool

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URL of the Trial

http://esca-life.org/

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Brief Summary in Lay Language

The main objective of ESCApreschool is to find out how to best help preschoolers with attention problems, preschoolers who are hyperactive, impulsive or show an extraordinarily strong urge to move.
We developed a new, stepped-care, adaptive treatment programme. It begins with a low treshhold intervention and only in case this does not suffice will additonal, more intense treatment be offered.
ESCApreschool starts with telephone assisted self-help for parents and the child's preschool teacher. This self-help entails brochures and ten telephone calls. If the child's symptoms persist, more interventions will be administered. That may be an intense training for parents and preschool teachers or psychiatric treatment as usual für children with attention deficits.
In order to find out which of these treatment combinations work best for which children, the study ESCApreschool has been designed. That means parents and preschool teachers of children who participate in ESCApreschool will have to fill out questionnaires on a regular basis.

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Brief Summary in Scientific Language

German and European clinical guidelines (Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie et al., 2007; National Institute for Health and Clinical Excellence, 2009; Taylor et al., 2004) recommend a stepped care approach with individualized adaptive treatment strategies. However, empirical evidence of the effectiveness of adaptive treatment strategies for preschool children with ADHD is sparse.
There’s evidence of the effectiveness of singular interventions like parent counseling, parent management training or behavioral therapy (Döpfner et al., 2007; Murray et al. 2010, Mulqueen et al., 2015) ). (Pharmacotherapy is not approved for treatment of preschoolers.)
A stepwise approach with individualized adaptive treatment strategies has not yet been empirically validated, which is why feasibility, efficacy and effectiveness have not been assessed to date. Thus, there is a need for clinical studies with an adaptive design for clinically referred samples.
Additional focus is put on analyzing the effectiveness of low threshold interventions like telephone assisted self-help (TASH) for preschool children. Telephone assisted self help could easily be widely implemented. If proven effective, this low cost, low threshold intervention could provide positive effects to a serious health care problem.

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Organizational Data

  •   DRKS00008971
  •   2015/10/01
  •   [---]*
  •   yes
  •   Approved
  •   87/15, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   F90 -  Hyperkinetic disorders
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Interventions/Observational Groups

  •   Step1: TASH-Intervention group. Three months of Telephone asissted self-help (TASH). Parents and kindergarten will receive brochures and afterwards 10 telephone calls by a therapist in training to learn how to better handle the child's ADHD. Appointments are individually set. (Duration Step 1: 3 months).
  •   Step1: TASH-Waiting-control-group. Three months of waiting is followed by three months of Telephone assisted self-help (TASH, 10 phone conversations with parents and preschool teacher) (Duration step 1: 6 months).
  •   Step1: TASH, Step2: Booster-sessions. In step 2 patiens who don't have ADHD any more after step 1, will receive three TASH-booster sessions, i.e. three phone calls to their parents to refresh the intervention from step 1. (Duration Step 2: 6 months)
  •   Step1: TASH, Step 2: Patients who still have ADHD after step 1 will receive more intense therapy in step 2. They will be randomized into one of two
    treatment arms – Parent Management and Preschool Teacher Training (PMPTT), PMPPT entails 20 weekly therapy sessions with the child, the parents or the preschool teacher (Duration step 2: 6 months).
  •   Step1: TASH, Step 2: Treatment as Usual. Patients who still have ADHD after step 1 will receive more intense therapy in step 2. They will be randomized into one of two
    treatment arms: This group will recieve Treatment as Usual, individualised child psychiatric treatment, according to the guidelines (Duration step 2: 6 months).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Change in blinded clinician-rated ADHD+ODDChecklist (DCL-ADHS+SSV) based on parent interview at baseline, 3/6 months, 9/12 months and 12/15 months.

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Secondary Outcome

Change in
- parent and teacher rated ADHD (FBB-ADHS-V) and ODD (FBB-SSV)
- comorbid symptoms (CBCL 1½-5, CTRF 1,5-5),
- impairment (WFIRS)
- quality of life (KIDDY-KINDL)
- Parenting Behavior (FZEV, FPNE, VER)
- Social Reactivity (SRS-kurz, CU-preschool)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2016/06/29
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   6   Years
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Additional Inclusion Criteria

- age: 3-6 years
- attending kindergarten,
- ADHD (DSM-5) or ODD with severe problems in attention and hyperacticity (clinician-rated ADHD/ODD-Checklist (DCL-ADHS(SSV).
- informed consent of parents/guardians; if possible informed consent of preschool teacher; assent of children

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Exclusion Criteria

- IQ < 80,
- pervasive developmental disorder; schizophrenia, bipolar disorder, severe depressive episodes,
- parents with insufficient German language skills,
- current medication for ADHD or other psychotrophic medication,
- intensive psychotherapies (on a weekly / biweekly basis).

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Addresses

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    • Philipps-Universität Marburg, Biegenstr. 10, 35037 Marburg, vertreten durch die Präsidentin Prof. Dr. Katharina Krause, ausführende Stelle: Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie am „Universitätsklinikum Gießen und Marburg GmbH“ Hans-Sachs-Str. 4, 35039 Marburg, Prof. Dr. Katja Becker
    • 35032  Marburg
    • Germany
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    • Universitätsklinikum Marburg, Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr.  Katja  Becker 
    • Hans-Sachs-Str. 6
    • 35039  Marburg
    • Germany
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    • Universitätsklinikum Marburg, Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
    • Ms.  Johanna  Ketter 
    • Hans-Sachs-Str. 6
    • 35039  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • 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.