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NCT Number: NCT02685254

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Mental Health and Addiction, Vestfold Hospital Trust

Tønsberg, 3103, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structural skills training group

Behavioral

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.

Other names: Dialectic behavioural group therapy

Treatment as Usual

Other

Treatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse

Primary outcomes

  1. Behaviour Rating Inventory of Executive Functions (BRIEF)

    Time frame: two years

    Change in executive function impairments

Secondary outcomes

  1. Adult ADHD self-report scale (ASRSv1.1), 18 items version

    Time frame: two years

    Change in ADHD symptoms

  2. Beck Depression Inventory (BDI)

    Time frame: two years

    Change in depressive symptoms

  3. Beck Anxiety Inventory (BAI)

    Time frame: two years

    Change in anxiety symptoms

  4. Weiss Functional Impairment Rating Scale, self-report (WIFRS)

    Time frame: two years

    Change in functional impairments

  5. Global Assessment of functioning (GAF)

    Time frame: two years

    Change in global symptoms and functioning

  6. Adult ADHD Quality of Life Scale (AAQoL)

    Time frame: two years

    Change in quality of life

  7. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: two years

    Change in emotional regulation

  8. Safety issue - Monitoring of adverse events

    Time frame: two years

    Monitoring of adverse events

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Haukeland University Hospital
  • Oslo University Hospital
  • The Hospital of Vestfold

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2016
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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