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
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
Scientific
Akademiska sjukhuset, ing 10
Uppsala
751 85
Sweden
Study information
| Study design | Randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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(s) | Regional Ethical Review Board in Uppsala, 26/08/2015, Dnr 2015/257 |
| 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 |
| Primary outcome measure | 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 study start date | 01/12/2015 |
| Overall study end date | 28/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 15 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 184 |
| 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 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 | 01/02/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Sweden
Sweden
Sweden
Sweden
Sweden
791 82
Sweden
721 89
Sweden
416 74
Sweden
Sponsor information
Hospital/treatment centre
Akademiska sjukhuset
Uppsala
751 85
Sweden
"ROR" |
https://ror.org/01dv86r63 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 10/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Publication is planned in 2019 |
| IPD sharing plan | Consent 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.
