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Clinical Trials/NCT02937142
NCT02937142
Completed
N/A

Cognitive Behavior Group Therapy in Adolescents (14-18 Years) With Attention Deficit Hyperactivity Disorder (ADHD)

St. Olavs Hospital1 site in 1 country100 target enrollmentJanuary 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
St. Olavs Hospital
Enrollment
100
Locations
1
Primary Endpoint
ADHD-Rating Scale (ADHD-RS)
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

Change February 1st 2017: Inclusion of patients with mild to moderate behavioral problems in order to achieve enough participants in the study. Change February 1st 2017: The study primarily recruits patients who are on pharmacological treatment for ADHD. However, for ethical reasons and in order to achieve enough participants, the study will also recruit patients who have not responded to at least two drug trials or have been unable to continue pharmacological treatment because of intolerable side effects. Change February 1st 2018: The Weiss Functional Impairment Rating Scale, Rosenberg and BRIEF questionnaires will not be collected at the 9-month follow-up due to lack of resources (project assistance).

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
October 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

ADHD-Rating Scale (ADHD-RS)

Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)

interview

Secondary Outcomes

  • ADHD-Rating Scale (ADHD-RS)(9 months)
  • Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)(9 months)
  • ASEBA Brief Problem Monitor(9 months)
  • Clinical Global Impression (CGI)(12 weeks (at baseline and immediately after the last group therapy session))
  • Weiss Functional Impairment Rating Scale (WFIRS)(9 months)
  • Children's Global Assessment Scale (CGAS)(9 months)
  • Anxiety symptoms (SCARED)(12 weeks (at baseline and immediately after the last group therapy session))
  • Depressive symptoms (Mood and Feelings Questionnaire (MFQ) Norwegian version "Humøret ditt")(12 weeks (at baseline and immediately after the last group therapy session))
  • Sleep problems (Adolescent Sleep Wake Scale(12 weeks (at baseline and immediately after the last group therapy session))
  • Self-esteem (Rosenberg Self-Esteem Scale)(9 months)
  • Self-efficacy (General Perceived Self-Efficacy Scale)(9 months)

Study Sites (1)

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