Clinical trial NCT02937142: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Behavior Therapy
Cognitive Therapy
Adolescents
Psychotherapy, Group
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2016-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: ADHD-Rating Scale (ADHD-RS)
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
Secondary outcomes:
measure: ADHD-Rating Scale (ADHD-RS)
timeFrame: 9 months
measure: Clinical Global Impression (CGI)
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Weiss Functional Impairment Rating Scale (WFIRS)
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Weiss Functional Impairment Rating Scale (WFIRS)
timeFrame: 9 months
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 9 months
measure: Anxiety symptoms (SCARED)
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Depressive symptoms (Mood and Feelings Questionnaire (MFQ) Norwegian version "Humøret ditt")
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Sleep problems (Adolescent Sleep Wake Scale
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Self-esteem (Rosenberg Self-Esteem Scale)
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Self-esteem (Rosenberg Self-Esteem Scale)
timeFrame: 9 months
measure: Self-efficacy (General Perceived Self-Efficacy Scale)
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Self-efficacy (General Perceived Self-Efficacy Scale)
timeFrame: 9 months
measure: Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)
timeFrame: 12 weeks (at baseline and immediately after the last group therapy session)
measure: Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)
timeFrame: 9 months
measure: ASEBA Brief Problem Monitor
timeFrame: 9 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital
Study officials:
affiliation: St Olavs Hospital University Hospital Trondheim
name: Torunn Stene Nøvik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.