Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Behavioral: cognitive behavior group therapy
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavior group therapy<br>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<br>* 1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.<br>Other: Treatment as usual<br>* Education on ADHD, and ADHD medication if indicated<br>|
| Other: Controls<br>Treatment as usual: Education on ADHD, and ADHD medication if indicated. | Other: Treatment as usual<br>* Education on ADHD, and ADHD medication if indicated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-Rating Scale (ADHD-RS) | interview | 12 weeks (at baseline and immediately after the last group therapy session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-Rating Scale (ADHD-RS) |  | 9 months | 
| Clinical Global Impression (CGI) |  | 12 weeks (at baseline and immediately after the last group therapy session) | 
| Weiss Functional Impairment Rating Scale (WFIRS) |  | 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) |  | 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) |  | 12 weeks (at baseline and immediately after the last group therapy session) | 
| Self-efficacy (General Perceived Self-Efficacy Scale) |  | 9 months | 
| Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF) |  | 12 weeks (at baseline and immediately after the last group therapy session) | 
| Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF) |  | 9 months | 
| ASEBA Brief Problem Monitor |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior Therapy, Cognitive Therapy, Adolescents, Psychotherapy, Group