Condition category
Mental and Behavioural Disorders
Date applied
14/02/2016
Date assigned
19/02/2016
Last edited
18/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A growing number of adults are diagnosed with Attention-Deficit Hyperactivity Disorder, or ADHD. People with ADHD can have problems in paying attention, feeling restless or hyperactive and behaving impulsively. Pharmacological (drug) treatments are well established, but a significant number of patients does not respond well or experience adverse effects, which results in them stopping the treatment. Furthermore many patients request for psychological treatment to help them with symptoms that are not resolved by simply taking drugs. There has been interest in looking at the potential effects of structured group therapy ,which has been useful to patients with other conditions. Some studies have shown that structured skills training groups are beneficial for adult sufferers of ADHD in outpatient psychiatric units, reducing ADHD symptoms in people who remained stable regarding their medication status. This study investigates the potential effects of structured skills training groups in a clinically relevant but still controlled setting, and whether they help alleviate symptoms and improve quality of life for adult ADHD sufferers.

Who can participate?
Adults that have been diagnosed with ADHD.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 have weekly active structured skills training group therapy sessions for 14 weeks, followed by their usual treatment for the reminder of the study. Those in group 2 are given their usual treatment, after which they are given 14 weeks of active structured skills training group therapy.

What are the possible benefits and risks of participating?
All patients taking part in this study will be offered an intensive and comprehensive psychological intervention with educational and supportive coaching for training in new mastery in their daily life. This is considered to be associated with significant opportunities for improvements and low risk for adverse effects. Patients will be followed up carefully so that any problems during treatment period could be detected early and dealt with in a clinically appropriate manner. All participants are then assessed in terms of whether their symptoms have improved.

Where is the study run from?
1. Haukeland University Hospital, Psychiatric Department (Norway)
2. Division of Mental Health and Addiction, Vestfold Hospital Trust (Norway)
3. Sørlandet Hospital, Kristiansand (Norway)
4. Stavanger University Hospital (Norway)
5. Østfold Hospital Trust (Norway)

When is the study starting and how long is it expected to run for?
June 2015 to December 2017

Who is funding the study?
1. Oslo University Hospital (Norway)
2. Haukeland University Hospital (Norway)

Who is the main contact?
1. Dr Anne Halmøy (scientific)
2. Dr Mats Fredriksen (scientific)
3. Mrs Bente Ubostad (public)
4. Ms Ellen Kathrine Munkhaugen (public)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anne Halmøy

ORCID ID

Contact details

Haukeland University Hospital
Psychiatric Department
Bergen
5021
Norway

Type

Scientific

Additional contact

Dr Mats Fredriksen

ORCID ID

http://orcid.org/0000-0002-8392-3366

Contact details

Division of Mental Health and Addiction
Vestfold Hospital Trust
Tønsberg
3101
Norway

Type

Public

Additional contact

Mrs Bente Ubostad

ORCID ID

Contact details

Regional Competence Center for Neurodevelopmental Disorders and Hypersomnias
West Norway Regional Health Authority
Haukeland University Hospital
Bergen
5021
Norway

Type

Public

Additional contact

Ms Ellen Kathrine Munkhaugen

ORCID ID

Contact details

Regional Competence Center for Autism
AD/HD,Tourettes Syndrome and Narcolepsy
South-Eastern Norway Regional Health Authority
Oslo University Hospital
Oslo
0424
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of structured skills training group in treatment of ADHD in adults: a controlled multicentre study

Acronym

Study hypothesis

The structured skills training group treatment is superior to the control condition 'treatment as usual' in reducing attention deficit hyperactivity disorder (ADHD) symptoms and functional deficits, and increasing quality of life in adults with ADHD.

Ethics approval

Regional Committees for Medical Research Ethics - South East Norway, 29/10/2015, ref: 2015/1523 A

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Available in Norwegian language

Condition

Attention deficit hyperactivity disorder

Intervention

Enrolled patients are randomised into two groups and allocated to either:
1. Group 1 (G1) with start of weekly treatment in active structured skills training group therapy lasting for 14 weeks, following the Norwegian translation of the Swedish version of the ADHD skills training manual/workbook (Hirvikoski 2011; Morgensterns 2015) based on an adaption of Marsha Linehan's dialectical behavior therapy (DBT) for borderline personality disorder. 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.
2. Group 2 (G2) with treatment as usual/clinical management for the first 15 weeks, followed by delayed admission to the active intervention of structured skills training group therapy (partial cross-over)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1.Change in executive function impairments (total and separate dimensional scores) assessed by the self/informant-reports of adults aged Behavior Rating Inventory of Executive Function (BRIEF-A) at end of 14-weeks group treatment, and after 6 months post-treatment, compared to baseline and treatment as usual as control treatment strategy
2. Change in emotional regulation (total and separate dimensional scores) assessed by the self/informant-reports Difficulties in Emotion Regulation Scale (DERS) at end of 14-weeks group treatment, and after 6 months post-treatment, compared to baseline and treatment as usual as control treatment strategy

Secondary outcome measures

1. Adult ADHD self-report scale (ASRS), the 18 items version
2. Beck Depression Inventory (BDI)
3. Beck Anxiety Inventory (BAI)
4. Alcohol Use Disorder Identification Test (AUDIT)
5. Drug Use Disorder Identification Test (DUDIT)
6. Weiss Functional Impairment Rating Scale, self-report (WIFRS)
7. Adult ADHD Quality of Life Scale (AAQoL)
8. Global Assessment of functioning (GAF)

Overall trial start date

22/06/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (age >= 18 years)
2. Both genders
3. Diagnosis of ADHD according to DSM-IV persisting in adulthood

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Between 100 - 120

Participant exclusion criteria

1. Any psychotic disorder
2. Recently suicidal behaviour
3. Substance or alcohol abuse or dependence within three months prior to screening for inclusion
4. Pervasive developmental disorder
5. Intellectual disability
6. Seizures or any neurological diseases causing mental handicap

Recruitment start date

14/02/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Norway

Trial participating centre

Haukeland University Hospital, Psychiatric Department
Bergen
5021
Norway

Trial participating centre

Division of Mental Health and Addiction, Vestfold Hospital Trust
Tønsberg
3101
Norway

Trial participating centre

Sørlandet Hospital, Kristiansand
Kristiansand
4604
Norway

Trial participating centre

Stavanger University Hospital, Stavanger
Stavanger
4068
Norway

Trial participating centre

Østfold Hospital Trust
1714
Norway

Sponsor information

Organisation

Regional Competence Center for Neurodevelopmental Disorders and Hypersomnias

Sponsor details

Haukeland University Hospital
Bergen
5021
Norway
+47 55974594
bente.ubostad@helse-bergen.no

Sponsor type

Not defined

Website

Organisation

Regional Competence Center for Neurodevelopmental Disorders and Hypersomnias

Sponsor details

South-Eastern Norway Regional Health Authority
Oslo University Hospital
Pb 4956 Nydalen
Oslo
0424
Norway
+47 22 11 80 96
ellmun@ous-hf.no

Sponsor type

Not defined

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Oslo University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Haukeland University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish data and results from the study in peer-reviewed journals

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes