Effects of Structured Skills Training Group in Treatment of ADHD in Adults
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- Behavioral: Structural skills training groupOther: Treatment as usual
- Registration Number
- NCT02685254
- Lead Sponsor
- University of Oslo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood
- Any psychotic disorder
- Recently suicidal behaviour
- Substance or alcohol abuse or dependence within three months prior to screening for inclusion
- Pervasive developmental disorder
- Intellectual disability
- Seizures or any neurological diseases causing mental handicap
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Initial group therapy Structural skills training group 'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training Initial control condition Treatment as usual Treatment as usual/clinical management the first 15 weeks pending deferred start of group therapy (partially cross-over)
- Primary Outcome Measures
Name Time Method Behaviour Rating Inventory of Executive Functions (BRIEF) two years Change in executive function impairments
- Secondary Outcome Measures
Name Time Method Adult ADHD self-report scale (ASRSv1.1), 18 items version two years Change in ADHD symptoms
Beck Depression Inventory (BDI) two years Change in depressive symptoms
Beck Anxiety Inventory (BAI) two years Change in anxiety symptoms
Weiss Functional Impairment Rating Scale, self-report (WIFRS) two years Change in functional impairments
Global Assessment of functioning (GAF) two years Change in global symptoms and functioning
Adult ADHD Quality of Life Scale (AAQoL) two years Change in quality of life
Difficulties in Emotion Regulation Scale (DERS) two years Change in emotional regulation
Safety issue - Monitoring of adverse events two years Monitoring of adverse events
Trial Locations
- Locations (1)
Division of Mental Health and Addiction, Vestfold Hospital Trust
🇳🇴Tønsberg, Norway