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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 9 January 2023
Main ID:  ISRCTN17366720
Date of registration: 27/06/2016
Prospective Registration: No
Primary sponsor: Uppsala County Council, Child and Adolescent Psychiatry (Landstinget i Uppsala län, Barn och ungdomspsykiatrin) (Sweden)
Public title: Structured skill training for adolescents with attention deficit hyperactivity disorder - a randomized controlled study
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
Date of first enrolment: 01/12/2015
Target sample size: 100
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN17366720
Study type:  Interventional
Study design:  Randomized controlled study (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Sweden
Contacts
Name: Johan    Isaksson
Address:  Akademiska sjukhuset, ing 10 751 85 Uppsala Sweden
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
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Affiliation: 
Key inclusion & exclusion criteria
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

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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Attention deficit hyperactivity disorder (ADHD)
Mental and Behavioural Disorders
Intervention(s)
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.
Primary Outcome(s)

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(s)

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
Secondary ID(s)
2015/257
Source(s) of Monetary Support
Uppsala University Hospital Research Fund (Sweden)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Regional Ethical Review Board in Uppsala, 26/08/2015, Dnr 2015/257
Results
Results available: Yes
Date Posted:
Date Completed: 28/02/2019
URL:
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