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Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT02937142
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder which starts in childhood and is characterized by symptoms of attention deficit, hyperactivity and impulsivity. Persistence into adolescence is frequently associated with among other low educational achievement, interpersonal difficulties, anxious and depressive symptoms and sleep problems. Treatment guidelines recommend psychological treatment as part of the treatment plan, however compared to children and adults, there is still a substantial lack of knowledge about appropriate psychological treatment in adolescents. The present study examines a psychological intervention for adolescents with ADHD, cognitive behavior group therapy. The intervention consists of 12 weekly cognitive behavioral therapy sessions addressing core difficulties and concerns of the adolescent population with ADHD. The investigators wish to determine the efficacy of group therapy in adolescents with ADHD who receive medical treatment but still have impairing ADHD symptoms.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Behavioral: cognitive behavior group therapy Other: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Group Therapy in Adolescents (14-18 Years) With Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive behavior group therapy
Cognitive behavior group therapy in weekly 1,5 hour sessions during 12 weeks, 8 participants and 2 therapists per group, in addition to education on ADHD, and ADHD medication if indicated.
Behavioral: cognitive behavior group therapy
1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.

Other: Treatment as usual
Education on ADHD, and ADHD medication if indicated

Controls
Treatment as usual: Education on ADHD, and ADHD medication if indicated.
Other: Treatment as usual
Education on ADHD, and ADHD medication if indicated




Primary Outcome Measures :
  1. ADHD-Rating Scale (ADHD-RS) [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
    interview


Secondary Outcome Measures :
  1. ADHD-Rating Scale (ADHD-RS) [ Time Frame: 9 months ]
  2. Clinical Global Impression (CGI) [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  3. Weiss Functional Impairment Rating Scale (WFIRS) [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  4. Weiss Functional Impairment Rating Scale (WFIRS) [ Time Frame: 9 months ]
  5. Children's Global Assessment Scale (CGAS) [ Time Frame: 9 months ]
  6. Anxiety symptoms (SCARED) [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  7. Depressive symptoms (Mood and Feelings Questionnaire (MFQ) Norwegian version "Humøret ditt") [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  8. Sleep problems (Adolescent Sleep Wake Scale [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  9. Self-esteem (Rosenberg Self-Esteem Scale) [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  10. Self-esteem (Rosenberg Self-Esteem Scale) [ Time Frame: 9 months ]
  11. Self-efficacy (General Perceived Self-Efficacy Scale) [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  12. Self-efficacy (General Perceived Self-Efficacy Scale) [ Time Frame: 9 months ]
  13. Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF) [ Time Frame: 12 weeks (at baseline and immediately after the last group therapy session) ]
  14. Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF) [ Time Frame: 9 months ]
  15. ASEBA Brief Problem Monitor [ Time Frame: 9 months ]


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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Attention deficit hyperactivity disorder (ICD-10)
  • Clinical Global Impression (CGI) >=3
  • Informed consent patient
  • informed consent parents
  • if on medication, dosage is stable since at least 2 months

Exclusion Criteria:

  • mental retardation
  • behavioral problems
  • drug addiction
  • psychosis
  • suicidal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937142


Contacts
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Contact: Torunn Stene Nøvik, MD PhD torunn.stene.novik@stolav.no

Locations
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Norway
Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Anne-Bjørg Nyseter       post.bup@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Petter Aadahl, MD PhD St Olavs Hospital University Hospital Trondheim

Additional Information:
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02937142     History of Changes
Other Study ID Numbers: 2015/2115
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Olavs Hospital:
Behavior Therapy
Cognitive Therapy
Adolescents
Psychotherapy, Group

Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms