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Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
cognitive behavior group therapy
Treatment as usual
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Behavior Therapy, Cognitive Therapy, Adolescents, Psychotherapy, Group

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cognitive behavior group therapy

Controls

Arm Description

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.

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

Outcomes

Primary Outcome Measures

ADHD-Rating Scale (ADHD-RS)
interview

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2016
Last Updated
December 1, 2021
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02937142
Brief Title
Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder
Official Title
Cognitive Behavior Group Therapy in Adolescents (14-18 Years) With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Behavior Therapy, Cognitive Therapy, Adolescents, Psychotherapy, Group

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavior group therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Controls
Arm Type
Other
Arm Description
Treatment as usual: Education on ADHD, and ADHD medication if indicated.
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavior group therapy
Intervention Description
1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Education on ADHD, and ADHD medication if indicated
Primary Outcome Measure Information:
Title
ADHD-Rating Scale (ADHD-RS)
Description
interview
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Secondary Outcome Measure Information:
Title
ADHD-Rating Scale (ADHD-RS)
Time Frame
9 months
Title
Clinical Global Impression (CGI)
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Title
Weiss Functional Impairment Rating Scale (WFIRS)
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Title
Weiss Functional Impairment Rating Scale (WFIRS)
Time Frame
9 months
Title
Children's Global Assessment Scale (CGAS)
Time Frame
9 months
Title
Anxiety symptoms (SCARED)
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Title
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)
Title
Sleep problems (Adolescent Sleep Wake Scale
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Title
Self-esteem (Rosenberg Self-Esteem Scale)
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Title
Self-esteem (Rosenberg Self-Esteem Scale)
Time Frame
9 months
Title
Self-efficacy (General Perceived Self-Efficacy Scale)
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Title
Self-efficacy (General Perceived Self-Efficacy Scale)
Time Frame
9 months
Title
Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)
Time Frame
12 weeks (at baseline and immediately after the last group therapy session)
Title
Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)
Time Frame
9 months
Title
ASEBA Brief Problem Monitor
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 suicidal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torunn Stene Nøvik, MD PhD
Organizational Affiliation
St Olavs Hospital University Hospital Trondheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32213517
Citation
Novik TS, Haugan AJ, Lydersen S, Thomsen PH, Young S, Sund AM. Cognitive-behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial. BMJ Open. 2020 Mar 25;10(3):e032839. doi: 10.1136/bmjopen-2019-032839.
Results Reference
background
PubMed Identifier
35655149
Citation
Haugan AJ, Sund AM, Young S, Thomsen PH, Lydersen S, Novik TS. Cognitive behavioural group therapy as addition to psychoeducation and pharmacological treatment for adolescents with ADHD symptoms and related impairments: a randomised controlled trial. BMC Psychiatry. 2022 Jun 2;22(1):375. doi: 10.1186/s12888-022-04019-6.
Results Reference
derived
Links:
URL
http://stolav.no/bup
Description
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Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

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