Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

NCT ID: NCT02937142

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-10-31

Brief Summary

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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

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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).

Conditions

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Attention Deficit Disorder With Hyperactivity

Keywords

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Behavior Therapy Cognitive Therapy Adolescents Psychotherapy, Group

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

cognitive behavior group therapy

Intervention Type BEHAVIORAL

1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.

Treatment as usual

Intervention Type OTHER

Education on ADHD, and ADHD medication if indicated

Controls

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

Group Type OTHER

Treatment as usual

Intervention Type OTHER

Education on ADHD, and ADHD medication if indicated

Interventions

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cognitive behavior group therapy

1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.

Intervention Type BEHAVIORAL

Treatment as usual

Education on ADHD, and ADHD medication if indicated

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torunn Stene Nøvik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St Olavs Hospital University Hospital Trondheim

Locations

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Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 32213517 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35655149 (View on PubMed)

Related Links

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Other Identifiers

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2015/2115

Identifier Type: -

Identifier Source: org_study_id