Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

Not Applicable

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Behavioral: cognitive behavior group therapy; Other: Treatment as usual

• Registration Number: NCT02937142
• Lead Sponsor: St. Olavs Hospital

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).

Study Timeline

• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Study Start: 2017-01
• Primary Completion: 2020-01
• Study Completion: 2020-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavior group therapy	Treatment as usual	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.
Cognitive behavior group therapy	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.
Controls	Treatment as usual	Treatment as usual: Education on ADHD, and ADHD medication if indicated.

Primary Outcome Measures

Name	Time	Method
ADHD-Rating Scale (ADHD-RS)	12 weeks (at baseline and immediately after the last group therapy session)	interview

Secondary Outcome Measures

Name	Time	Method
ADHD-Rating Scale (ADHD-RS)	9 months
Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)	9 months
ASEBA Brief Problem Monitor	9 months
Clinical Global Impression (CGI)	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)	9 months
Self-efficacy (General Perceived Self-Efficacy Scale)	9 months

Trial Locations

Locations (1)

Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital; 🇳🇴 Trondheim, Norway