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Table 2 Measures

From: ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial

 

T0

T1 Week 1

T2 Week 12/24 ± 14 days

T3 Week 24/36 ± 14 days

T4 Week 36/48 ± 14 days

 

Assessment for eligibility

Study visit: Baseline

Study visit: After step 1

Study visit: After step 2

Study visit: Follow-up

Screening and inclusion/exclusion criteria

X

    

Informed consent

X

    

Drug screening

Xa

Xa

b

b

b

Medical history

X

    

Pregnancy test (urine)

X

Xa

c

c

c

IDA-R Interview

X

X

X

X

X

CGI

 

X

X

X

X

WRAADS

 

X

X

X

X

IQ (WST)

X

    

M.I.N.I.

X

    

WFIRS

 

X

X

X

X

SCL-90-S

 

X

X

X

X

AAQoL-29

 

X

X

X

X

CTQ

X

    

PSQI

 

X

X

X

X

STAXI-2

 

X

X

X

X

QB Test

 

X

X

X

X

TMS

 

X

X

X

X

EEGd

  

X

X

 

Adherence

   

X

 

List comorbiditye

X

X

X

X

X

Socioeconomic status

X

X

X

X

X

Psychopathology and comorbid conditionse in short study visits during step 1

Week 4 and 8; for waiting list group additionally in week 16 and 20

Psychopathology and comorbid conditionse in short study visits during step 2

Week 16 and 20; for waiting list group additionally in week 28 and 32

Safety assessmentse during step 2 for methylphenidate treatment

Week 13, 14, 15, 16, 18, 20 and 22, while waiting list group will undergo these safety assessments three months later (week 25, 26, 27, 28, 30, 32 and 34)

Adverse events according psychiatric adverse events (PAEs)

Weekly/biweekly between T2 and T3

  1. a According to clinical routine and center standards
  2. bOnly if drug abuse is suspected
  3. cOnly if pregnancy is suspected
  4. dOnly for patients in the NF groups
  5. eA study-specific investigator report, which allows the assessment of neurological as well as psychiatric symptoms
  6. AAQOL-29 Adult ADHD Quality of Life Scale, CGI Clinical Global Impression Scale, CTQ Childhood Trauma Questionnaire, EEG electroencephalogram, IDA-R Integrated Diagnostic Scale of adult ADHD – Revised, M.I.N.I. 6.0 The International Neuropsychiatric Interview (Version 6), PSQI Pittsburgh Sleep Quality Index, QB Quantified Behavior Test, SCL-90-S Symptom Checklist-90-Standard, STAXI-2 State-Trait Anger Expression Inventory 2, T test time, TMS transcranial magnetic stimulation, WFIRS Weiss Functional Impairment Rating Scale, WRAADS Wender Reimherr Adult Attention Deficit Disorder Scale, WST Wortschatztest (vocabulary-based IQ screening)