Condition category
Mental and Behavioural Disorders
Date applied
11/05/2016
Date assigned
27/06/2016
Last edited
23/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a group of behavioural symptoms that include inattentiveness, hyperactivity and impulsiveness. Dialectical Behavior Therapy is a kind of behavioral therapy and has been adjusted to be used for adults with ADHD. The treatment focuses on mindfulness, acceptance/change and applied behaviour analysis. DBT in groups has shown promising results in adult populations in both Germany and Sweden with a reduction in ADHD symptoms and aggressive behaviour, as well as higher quality of life. Since no study has been done on children, the aim of this study is to investigate if the same results can be achieved with adolescents.

Who can participate?
Patients aged 15-18 with ADHD

What does the study involve?
Participants are randomly allocated to receive either the DBT treatment or a psycho-educational treatment (focusing on psycho-education about ADHD and strategies to cope with the symptoms). The treatment effects are assessed using questionnaires before, during and after treatment.

What are the possible benefits and risks of participating?
Benefits include increased awareness of ADHD symptoms and increased capacity to cope with them, as well as the experience of social support from the group. The risks are that increased awareness leads to negative emotions and perceived stigma.

Where is the study run from?
Uppsala County Council, Child and Adolescent Psychiatry (Sweden)

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

Who is funding the study?
Uppsala University Hospital Research Fund (Sweden)

Who is the main contact?
Dr Johan Isaksson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Johan Isaksson

ORCID ID

Contact details

Akademiska sjukhuset
ing 10
Uppsala
751 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2015/257

Study information

Scientific title

Structured skill training in groups for adolescents with attention deficit hyperactivity disorder - a randomized controlled study comparing effect of dialectical behavioral therapy and psycho-educational intervention on symptoms of ADHD and level of functioning

Acronym

ADHD/DBT/SKILLS

Study hypothesis

Dialectical behavioral therapy will be more effective then psycho-educational intervention at reducing symptoms of ADHD and increasing level of functioning.

Ethics approval

Regional Ethical Review Board in Uppsala, 26/08/2015, Dnr 2015/257

Study design

Randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Attention deficit hyperactivity disorder (ADHD)

Intervention

One hundred adolescents diagnosed with ADHD will be recruited from child psychiatric outpatient units situated in the Swedish counties Falun, Gävle, Karlstad, Mölndal, Uppsala and Växjö. The adolescents (15-18 years old) who agree to take part in the study will be randomized into either the Dialectical Behavioral Therapy (DBT) treatment or the psycho-educational intervention (focusing on psychoeducation about ADHD and strategies to cope with the symptoms). The treatment effects will be assessed using standardized questionnaires, before, during and after treatment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Adult ADHD Self-Report Scale Adolescent version (ASRS-A)
2. Sheehan Disability Scale (SDS)
3. Visual Analogue Scale measuring impact of ADHD symptoms on daily life
4. Global Quality of Life scale (GQL)
5. Five Facets Mindfulness Questionnaire-Swedish version (FFMQ-SWE)

All measurements: One to two weeks before treatment starts, and one to two weeks after treatment ends and six months after treatment ends
After every session: GQL, VAS
At half time of the DBT treatment, participants will fill in GQL, VAS and ASRS, SDS and PAS

Secondary outcome measures

1. Strength and Difficulties Questionnaire (SDQ)
2. Hospital Anxiety and Depression Scale (HAD)
3. Pressure Activation Stress scale (PAS)
4. Karolinska Sleep Questionnaire (KSQ)

All measurements: One to two weeks before treatment starts, and one to two weeks after treatment ends and six months after treatment ends
After every session: GQL, VAS
At half time of the DBT treatment, participants will fill in GQL, VAS and ASRS, SDS and PAS

Overall trial start date

01/12/2015

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. 15-18 years old
2. Patient at the child psychiatric clinic
3. Fullfilling criteria for ADHD, ADD, HDD or ADHD NOS
4. No change in medication during the previous month before start of treatment
5. No other ongoing psychological treatment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Ongoing substance use disorders
2. Suicide risk
3. Mental retardation
4. Neurological disorder
5. Autism spectrum disorder
6. Manic episode
7. Severe depressive episode

Recruitment start date

01/12/2015

Recruitment end date

01/02/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Barn och ungdomspsykiatri, Akademiska sjukhuset
75185 Uppsala
Sweden

Trial participating centre

Barn och ungdomspsykiatri, Centralsjukhuset i Karlstad
65185 Karlstad
Sweden

Trial participating centre

Barn och ungdomspsykiatri, Region Gävleborg
801 30 Gävle
Sweden

Trial participating centre

BUP mottagningen, Mölndal
431 02 Mölndal
Sweden

Trial participating centre

Barn och ungdomspsykiatriska kliniken, Centrallasarettet i Växjö
351 85 Växjö
Sweden

Trial participating centre

BUP mottagningen i Falun
791 82 Falun
Sweden

Sponsor information

Organisation

Uppsala County Council, Child and Adolescent Psychiatry (Landstinget i Uppsala län, Barn och ungdomspsykiatrin) (Sweden)

Sponsor details

Akademiska sjukhuset
Uppsala
751 85
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Uppsala University Hospital Research Fund (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication is planned in 2018

Intention to publish date

01/07/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes