Trial document




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  DRKS00008975

Trial Description

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Title

Evidence-Based, Stepped Care in Late Adolescents and Young Adults with ADHS

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Trial Acronym

ESCAlate

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URL of the Trial

http://esca-life.org/

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Brief Summary in Lay Language

Regarding the treatment of adult ADHD many different methods have been proven to be useful. In German national practise the daily treatment of the patients is not only influenced by the results of clinical studies but also by recommendations of treatment guidelines and by requirements of sublegal institutions (gemeinsamer Bundesausschuss). The main aspect of these regulations is the requirement of a stepped care approach as the most useful treatment in ADHD patients.
The stepped care model has not been validated yet.
Thus this study will analyze the effect of a stepped care treatment in a trial.
The study is designed in a 2 step design. In the first step the patients will be randomized in one of three arms.
In step 2 they will be randomized and treated according response.

With amendment from December 20th 2016 the inclusion criteria "age" changed (from old = 16-35 years to new = 16-45 years). The amendment was accepted from the Ethic Ethic committee on January 25th 2017.

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Brief Summary in Scientific Language

Due to specific in- and exclusion criteria of pharmacological studies it is hard to generalize the results of the pharmacological trials and to assign the results to the general population. Regarding low level psychosocial treatment options psychoeducation is well established in daily practice (D‘Amelio et al. 2009). TASH interventions were found useful in children and adolescents (McGrath et al. 2011). TASH in children and adolescents is directed to the parents of the ADHD patient. In adult psychiatry the ADHD patient is the recipient of the treatment. Insofar the results of studies in children and adolescent cannot be transferred directly to adulthood. In adults to date there is only one published randomised controlled pilot study evaluating an 8-week bibliotherapy program with minimal therapists contact by phone calls (Stevenson et al., 2003) which revealed significant improvement of the symptoms of ADHD.

The few available studies and the complete lack of evidence from adults underline the need for the current study to clarify these in a stepped care design.

Thus this study is designed as follows:

Step 1 : Randomization into either:

- Face-to-face psychoeducation
- Telefon assisted self help programm (TASH)
- waiting control group followed by TASH

Step 2 (depending on response):

- single counseling and symptom control
or (randomized)
- neurofeedback with single counseling
- single counseling
or (randomized)
- Methylphenidat (according SMPC) and Neurofeedback
- Methylphenidat (according SMPC)

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Organizational Data

  •   DRKS00008975
  •   2015/10/23
  •   [---]*
  •   yes
  •   Approved
  •   161/15, Ethik-Kommission bei der Ärztekammer des Saarlandes
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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

  •   Step 1: Face-to-face Psychoeducation (PE) for three months. PE includes 8 sessions.
  •   Step 1: Telefon assisted self help programm (TASH) for three months; TASH includes 8 sessions. The sessions could be conducted by:
    physicians, psychiatrists, psychotherapists and psychotherapists in education
  •   Step 1: Waiting Control Group for three months followed by TASH
    .
  •   Step 2 a: If response of IDA-R is ≤ 18 the patients get six counseling sessions for symptom control for a duration of three months. The patients do not get medication or psychotherapeutic treatment.
  •   Step 2 ba: If response of IDA-R > 19 ≤ 27
    patients will be randomized and get six sessions of counseling and 30 sessions of neurofeedback for three months.
  •   Step 2 bb: If response of IDA-R > 19 ≤ 27 the patients will be randomized and get six single counseling sessions for three months.
  •   Step 2 ca: If IDA-R≥28 the Patients wil be randomized and get a combined neurofeedback and methylphenidat treatment (medication will be prescribed according SMPC) for three months. In total 30 neurofeedback session (with 2-3 sessions per week) are planned.
  •   Step 2 ca: If IDA-R≥28 the Patients wil be randomized and get a methylphenidat treatment (medication will be prescribed according SMPC) for three 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
  •   No
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Primary Outcome

Change of the ADHD symptoms by blinded expert rater via structured interview IDA-R at T0//1, T2, T3 and T4

T0/T1: at start of study
T2: after completion of step 1 (after 3 months)
T3: after completion of step 2 (after 6 months)
T4: after 3 months follow-up (after 9 months)

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Secondary Outcome

- WFIRS-S, which is a self-rating scale for the assessment of functional
problems in 7 domains of daily life; at T1; T2, T3, T4.
- Wender-Reimherr Interview. This is the
German version of a structured interview to assess ADHD symptoms; at T1, T2, T3 and T4
- The AAQOL is a 29-item disease-specific quality-of-life measure; at T1, T2, T3 and T4
- SCL-90-R : a 90-item self-report
symptom inventory to measure psychological symptoms and psychological distress: at T1, T2, T3 and T4
- PSQI : self-rated questionnaire which assesses sleep quality and disturbance over a 1-month time interval; at T1, T2, T3 and T4
- Anger-management will be assessed by the State-Trait Anger Expression Inventory – 2 (STAXI-2); at T1, T2, T3 and T4
- For the assessment of the psychopathology of comorbid conditions the Symptom-Checklist--90-symptom will be used; at T0, T1, T2, T3 and T4
- Aspects of quality of life will be assessed by the Adult ADHD Quality-of-Life Scale Questionnaire (AAQOL-29) at T1, T2, T3 and T4.
- M.I.N.I. 6.0: The M.I.N.I is a short, structured diagnostic interview and is a
structured psychiatric interview of choice for psychiatric evaluation and outcome tracking in
clinical psychopharmacology trials and epidemiological studies; at T0.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2016/01/28
  •   279
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   45   Years
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Additional Inclusion Criteria

ADHD according to the DSM-5 criteria as measured by the IDA-R interview, age between 16;00 to 45;11 years;

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Exclusion Criteria

IQ ≤ 80, acute substance dependence (alcohol and illegal
drugs), antisocial personality disorder, any psychotic disorder, any severe affective or bipolar disorder, epilepsy, any significant heart disease, pregnancy, insufficient command over the German language

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Addresses

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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) 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.