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Attention Deficit Disorder With HyperactivityNCT02937142

Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

A study testing cognitive behavior group therapy and Treatment as usual in people with Attention Deficit Disorder With Hyperactivity, run by St. Olavs Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 18 years
What is being tested?
cognitive behavior group therapy and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteNorway
Study dates
Jan 2017to Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • mental retardation
  • behavioral problems
  • drug addiction
  • psychosis
  • suicidal

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

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

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.

Read the 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).

Being tested
cognitive behavior group therapy, Treatment as usual
Keywords
Behavior Therapy, Cognitive Therapy, Adolescents, Psychotherapy, Group
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive behavior group therapyBehavioural

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

  • Treatment as usualOther

    Education on ADHD, and ADHD medication if indicated

Study groups in NCT02937142
Study groupRoleWhat they receive
Cognitive behavior group therapyExperimentalCognitive 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.
Receives: Behavioral: cognitive behavior group therapy; Other: Treatment as usual
ControlsOtherTreatment as usual: Education on ADHD, and ADHD medication if indicated.
Receives: Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ADHD-Rating Scale (ADHD-RS)

    interview

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

Secondary outcomes (15)

  1. ADHD-Rating Scale (ADHD-RS)

    Measured: 9 months

  2. Clinical Global Impression (CGI)

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  3. Weiss Functional Impairment Rating Scale (WFIRS)

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  4. Weiss Functional Impairment Rating Scale (WFIRS)

    Measured: 9 months

  5. Children's Global Assessment Scale (CGAS)

    Measured: 9 months

  6. Anxiety symptoms (SCARED)

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  7. Depressive symptoms (Mood and Feelings Questionnaire (MFQ) Norwegian version "Humøret ditt")

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  8. Sleep problems (Adolescent Sleep Wake Scale

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  9. Self-esteem (Rosenberg Self-Esteem Scale)

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  10. Self-esteem (Rosenberg Self-Esteem Scale)

    Measured: 9 months

  11. Self-efficacy (General Perceived Self-Efficacy Scale)

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  12. Self-efficacy (General Perceived Self-Efficacy Scale)

    Measured: 9 months

  13. Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)

    Measured: 12 weeks (at baseline and immediately after the last group therapy session)

  14. Executive functioning (Behavior Rating Scale of Executive Functioning, BRIEF)

    Measured: 9 months

  15. ASEBA Brief Problem Monitor

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2020
  4. Study completionOct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02937142
Sponsor's protocol ID
2015/2115
Status last verified
Dec 2021
First submitted
14 Oct 2016
Last updated
16 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32213517

  • 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.

    PubMed 35655149

Questions about this trial

What is this clinical trial studying?

A study testing cognitive behavior group therapy and Treatment as usual in people with Attention Deficit Disorder With Hyperactivity, run by St. Olavs Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADHD-Rating Scale (ADHD-RS) (time frame: 12 weeks (at baseline and immediately after the last group therapy session)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02937142, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.

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