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

May 28, 2018 updated by: Mats Fredriksen, University of Oslo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tønsberg, Norway, 3103
        • Division of Mental Health and Addiction, Vestfold Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Oslo University Hospital
Haukeland University Hospital
The Hospital of Vestfold

Investigators

  • Study Director: Ellen K Munkhaugen, MSED, Hospital of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1523 A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data from each site will be anonymised in the final analyses

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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