NCT02937142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

3 years

First QC Date

October 14, 2016

Last Update Submit

December 1, 2021

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Behavior TherapyCognitive TherapyAdolescentsPsychotherapy, Group

Outcome Measures

Primary Outcomes (1)

  • ADHD-Rating Scale (ADHD-RS)

    interview

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

Secondary Outcomes (15)

  • ADHD-Rating Scale (ADHD-RS)

    9 months

  • Clinical Global Impression (CGI)

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

  • Weiss Functional Impairment Rating Scale (WFIRS)

    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

  • +10 more secondary outcomes

Study Arms (2)

Cognitive behavior group therapy

EXPERIMENTAL

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.

Behavioral: cognitive behavior group therapyOther: Treatment as usual

Controls

OTHER

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

Other: Treatment as usual

Interventions

cognitive behavior group therapyBEHAVIORAL

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

Cognitive behavior group therapy
Treatment as usualOTHER

Education on ADHD, and ADHD medication if indicated

Cognitive behavior group therapyControls

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barne- og ungdomspsykiatrisk poliklinikk, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

  • 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.

    PMID: 32213517BACKGROUND

  • 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.

    PMID: 35655149DERIVED

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Torunn Stene Nøvik, MD PhD

    St Olavs Hospital University Hospital Trondheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

October 1, 2020

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)