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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:
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ISRCTN |
Last refreshed on:
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9 January 2023 |
Main ID: |
ISRCTN17366720 |
Date of registration:
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27/06/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Structured skill training for adolescents with attention deficit hyperactivity disorder - a randomized controlled study
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Scientific title:
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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:
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01/12/2015 |
Target sample size:
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100 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN17366720 |
Study type:
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Interventional |
Study design:
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Randomized controlled study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Johan
Isaksson |
Address:
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Akademiska sjukhuset, ing 10
751 85
Uppsala
Sweden |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Attention deficit hyperactivity disorder (ADHD) Mental and Behavioural Disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Uppsala University Hospital Research Fund (Sweden)
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Ethics review
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Status:
Approval date:
Contact:
Regional Ethical Review Board in Uppsala, 26/08/2015, Dnr 2015/257
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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28/02/2019 |
URL:
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