Structured skill training for adolescents with attention deficit hyperactivity disorder - a randomized controlled study

ISRCTN ISRCTN17366720
DOI https://doi.org/10.1186/ISRCTN17366720
Secondary identifying numbers 2015/257
Submission date
11/05/2016
Registration date
27/06/2016
Last edited
08/12/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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 February 2019.

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

Who is the main contact?
Dr Johan Isaksson

Contact information

Dr Johan Isaksson
Scientific

Akademiska sjukhuset, ing 10
Uppsala
751 85
Sweden

Study information

Study designRandomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleStructured 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
Study acronymADHD/DBT/SKILLS
Study hypothesisDialectical behavioral therapy will be more effective then psycho-educational intervention at reducing symptoms of ADHD and increasing level of functioning.
Ethics approval(s)Regional Ethical Review Board in Uppsala, 26/08/2015, Dnr 2015/257
ConditionAttention deficit hyperactivity disorder (ADHD)
InterventionOne 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 study start date01/12/2015
Overall study end date28/02/2019

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit15 Years
Upper age limit18 Years
SexBoth
Target number of participants100
Total final enrolment184
Participant inclusion criteria1. 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 exclusion criteria1. 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 date01/12/2015
Recruitment end date01/02/2018

Locations

Countries of recruitment

  • Sweden

Study participating centres

Barn och ungdomspsykiatri, Akademiska sjukhuset
75185 Uppsala
Sweden
Barn och ungdomspsykiatri, Centralsjukhuset i Karlstad
65185 Karlstad
Sweden
Barn och ungdomspsykiatri, Region Gävleborg
801 30 Gävle
Sweden
BUP mottagningen, Mölndal
431 02 Mölndal
Sweden
Barn och ungdomspsykiatriska kliniken, Centrallasarettet i Växjö
351 85 Växjö
Sweden
BUP mottagningen i Falun
Falun
791 82
Sweden
Barn och ungdomspsykiatrin, Västmanlands sjukhus
Västerås
721 89
Sweden
Barn och ungdomspsykiatrin, Västra Götaland
Gothenburg
416 74
Sweden

Sponsor information

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

Akademiska sjukhuset
Uppsala
751 85
Sweden

ROR logo "ROR" https://ror.org/01dv86r63

Funders

Funder type

Hospital/treatment centre

Uppsala University Hospital Research Fund (Sweden)

No information available

Results and Publications

Intention to publish date10/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPublication is planned in 2019
IPD sharing planConsent was obtained from all participants, data is made anonymous and all participants have a study number. Participants reported on web-based questionnaires, and they are retrieved and stored on a encrypted server. Diagnostic and data collected with paper-pencil is stored in a locked repository situated at the hospital. Anonymous databases are stored on a server protected with personal passwords, available only for the research group. Any request for access to data should be sent to Dr Johan Isaksson, and evaluated in accordance with the ethical approval.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 10/06/2019 12/06/2019 Yes No
Results article results 01/03/2021 16/03/2021 Yes No
Results article follow-up data 06/12/2022 08/12/2022 Yes No

Editorial Notes

08/12/2022: Publication reference added.
16/03/2021: Publication reference added.
10/12/2019: The following changes have been made:
1. The total final enrolment number has been added.
2. The intention to publish date has been changed from 30/06/2019 to 10/12/2020.
12/06/2019: Publication reference added.
05/02/2019: The following changes have been made:
1. The recruitment end date has been changed from 01/02/2017 to 01/02/2018.
2. The overall trial end date has been changed from 30/06/2018 from to 28/02/2019.
3. The plain English summary has been updated to reflect these changes.
4. Barn och ungdomspsykiatrin [child and adolescent psychiatry], Västmanland, and Barn och ungdomspsykiatrin, Västra Götaland have been added as trial participating centres.
05/09/2018: Intention to publish date and IPD sharing statement added.
24/08/2018: The overall trial end date was changed from 30/06/2017 to 30/06/2018.