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NCT Number: NCT02937142

Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital

Trondheim, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavior group therapy

Behavioral

1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.

Treatment as Usual

Other

Education on ADHD, and ADHD medication if indicated

Primary outcomes

  1. ADHD-Rating Scale (ADHD-RS)

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

    interview

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2016
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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