An interventional study of Structural skills training group and Treatment as usual in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by University of Oslo · Not applicable, Interventional, and Treatment
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training
Behavioral: Structural skills training group
Treatment as usual/clinical management the first 15 weeks pending deferred start of group therapy (partially cross-over)
Other: Treatment as usual
Weekly 2-hours sessions for 14 weeks follow the Norwegian translation of the Swedish version of the ADHD skills training manual/workbook (Hesslinger 2010; Hirvikoski 2011; Morgensterns 2015) which is based on an adaption of Marsha Linehan's dialectical behavior therapy (DBT) for borderline personality disorder into a group-based skills training program for adults with ADHD (Hesslinger 2002; Philipsen 2007). The groups embrace 7 - 10 participants, and two group leaders trained in group therapy, cognitive-behavioral treatment or DBT. Each session contains an initial short repetition and feedback on the previous session, followed by review of the homework during the first hour. After a break, a new topic with exercises and homework for the following week is introduced.
Also known as: Dialectic behavioural group therapy
Treatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse
Behaviour Rating Inventory of Executive Functions (BRIEF)
Change in executive function impairments
Time frame: two years
Adult ADHD self-report scale (ASRSv1.1), 18 items version
Change in ADHD symptoms
Time frame: two years
Beck Depression Inventory (BDI)
Change in depressive symptoms
Time frame: two years
Beck Anxiety Inventory (BAI)
Change in anxiety symptoms
Time frame: two years
Weiss Functional Impairment Rating Scale, self-report (WIFRS)
Change in functional impairments
Time frame: two years
Global Assessment of functioning (GAF)
Change in global symptoms and functioning
Time frame: two years
Adult ADHD Quality of Life Scale (AAQoL)
Change in quality of life
Time frame: two years
Difficulties in Emotion Regulation Scale (DERS)
Change in emotional regulation
Time frame: two years
Safety issue - Monitoring of adverse events
Monitoring of adverse events
Time frame: two years
Plan to share: No — Data from each site will be anonymised in the final analyses
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University of Oslo