Effects of Structured Skills Training Group in Treatment of ADHD in Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Structured Skills Training Group in Treatment of ADHD in Adults: a Controlled Multicentre Study

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Behavioral: Structural skills training group
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial group therapy<br>'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training | Behavioral: Structural skills training group<br>* 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.<br>* Other names: Dialectic behavioural group therapy;|
| Other: Initial control condition<br>Treatment as usual/clinical management the first 15 weeks pending deferred start of group therapy (partially cross-over) | Other: Treatment as usual<br>* Treatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behaviour Rating Inventory of Executive Functions (BRIEF) | Change in executive function impairments | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD self-report scale (ASRSv1.1), 18 items version | Change in ADHD symptoms | two years | 
| Beck Depression Inventory (BDI) | Change in depressive symptoms | two years | 
| Beck Anxiety Inventory (BAI) | Change in anxiety symptoms | two years | 
| Weiss Functional Impairment Rating Scale, self-report (WIFRS) | Change in functional impairments | two years | 
| Global Assessment of functioning (GAF) | Change in global symptoms and functioning | two years | 
| Adult ADHD Quality of Life Scale (AAQoL) | Change in quality of life | two years | 
| Difficulties in Emotion Regulation Scale (DERS) | Change in emotional regulation | two years | 
| Safety issue - Monitoring of adverse events | Monitoring of adverse events | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group Therapy, Structured Skills Training, Dialectic Behavioural Therapy