Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial
Official title:
Effects of Structured Skills Training Group in Treatment of ADHD in Adults: a Controlled Multicentre Study
This study aims to examine if structured skills training group therapy for ADHD in adults has
beneficial effects superior to 'treatment as usual' including medication in a controlled
outpatient setting on clinically relevant outcomes including symptoms, functioning and
quality of life measures.
The trial is designed as a multicenter randomized controlled, parallel group study. Patients
are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial
intervention by structured skills training groups by weekly sessions or one with control
condition (treatment as usual). Then after 15 weeks patients in the control condition arm are
switched to the active intervention by 14 weeks of structured group therapy. All patients are
assessed for defined outcomes after six months.
Background: The focus in recent years on evidence for non-pharmacological treatment in adults
with ADHD raises the question of potential effects of structured group therapy. Structured
skills training groups have shown beneficial effects in some studies in an outpatient
psychiatric context by reduction in ADHD symptoms in individuals who remained stable
regarding medication status.
Aims: The main objective for the trial is to investigate the potential effects of structured
skills training groups in a clinically relevant but still controlled setting on broader
outcomes including both symptomatic, functional and health related quality of life measures.
Methods/Design: The trial is designed as a multicenter randomized controlled parallel group
design. At each outpatient site the enrolled patients are randomized into two groups for
either Group 1 (G1) with start of weekly treatment in active structured skills training group
lasting for 14 weeks or allocated to Group 2 (G2) with treatment as usual/clinical management
and with 15 weeks delayed start of their group treatment for comparison wth patients in the
other arm. Those patients in the control condition arm receiving treatment as usual or
clinical management of individual patients (G2), are thereafter switched to active structured
skills training group therapy.All patients are followed up after six months with assessments
of primary and secondary outcomes.
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