Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937142
• Other study ID #: 2015/2115
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: October 2020

Study information

• Verified date: December 2021
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
Norway	Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Nøvik 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. — View Citation

Outcome

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

External Links

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