Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

December 1, 2021 updated by: St. Olavs Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
ADHD-Rating Scale (ADHD-RS)
Time Frame: 9 months
9 months
Clinical Global Impression (CGI)
Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)
12 weeks (at baseline and immediately after the last group therapy session)
Weiss Functional Impairment Rating Scale (WFIRS)
Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)
12 weeks (at baseline and immediately after the last group therapy session)
Weiss Functional Impairment Rating Scale (WFIRS)
Time Frame: 9 months
9 months
Children's Global Assessment Scale (CGAS)
Time Frame: 9 months
9 months
Anxiety symptoms (SCARED)
Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)
12 weeks (at baseline and immediately after the last group therapy session)
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)
12 weeks (at baseline and immediately after the last group therapy session)
Sleep problems (Adolescent Sleep Wake Scale
Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)
12 weeks (at baseline and immediately after the last group therapy session)
Self-esteem (Rosenberg Self-Esteem Scale)
Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)
12 weeks (at baseline and immediately after the last group therapy session)
Self-esteem (Rosenberg Self-Esteem Scale)
Time Frame: 9 months
9 months
Self-efficacy (General Perceived Self-Efficacy Scale)
Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)
12 weeks (at baseline and immediately after the last group therapy session)
Self-efficacy (General Perceived Self-Efficacy Scale)
Time Frame: 9 months
9 months
Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)
Time Frame: 12 weeks (at baseline and immediately after the last group therapy session)
12 weeks (at baseline and immediately after the last group therapy session)
Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)
Time Frame: 9 months
9 months
ASEBA Brief Problem Monitor
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Torunn Stene Nøvik, MD PhD, St Olavs Hospital University Hospital Trondheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/2115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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