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Attention Deficit Hyperactivity DisorderNCT03337425

Psychoeducational Groups for Adults With ADHD

A study testing Psychoeducational group therapy, Waiting list and Standard treatment in people with Attention Deficit Hyperactivity Disorder, run by Norwegian University of Science and Technology at 2 sites 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

This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Read more about this study

Who is it for?
Ages 18 to 67 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
Psychoeducational group therapy, Waiting list and Standard treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesNorway
Study dates
15 Nov 2017to 15 Jun 2019
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 18 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • confirmed ADHD diagnosis
  • speaking a Scandinavian language

Who cannot join

  • not able or willing to give informed consent
  • psychosis
  • severe learning difficulties

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Levanger Hospital, Nord-Trøndelag Hospital Trust

    Levanger, N-T

  • Tiller DPS - St. Olavs University Hospital

    Trondheim, S-T, 7040

Other trials in Norway

About this study

Official title: Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial

This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Assessment of client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS), and work participation will be conducted at time of recruitment prior to randomization (T0), pre- (T1), post-treatment (T2), with a 10 week follow-up.

Being tested
Psychoeducational group therapy, Waiting list, Standard treatment
Keywords
Psychotherapy, group, Adults
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.

  • Psychoeducational group therapyBehavioural

    The group-based psychoeducational program consists of 10 sessions, run over 10 consecutive weeks. Each session consist of a lecture, given by a recruited expert on the topic of the session (20 minutes) with a following discussion of the topic (45 minutes), facilitated by the course leader. All sessions are organized and led by the course leader, which also includes keeping structure in time, discussion and closing of the session. Psychoeducation comes in addition to standard treatment (ADHD treatment as usual).

  • Waiting listBehavioural

    Waiting list and standard treatment (ADHD treatment as usual)

  • Standard treatmentOther

    Also called Treatment as usual

    Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is not systematically given to every patient. If needed, patients are also offered assistance with regard to economy, housing, education and work. As well as contact with family and network.

Study groups in NCT03337425
Study groupRoleWhat they receive
psychoeducational groupsExperimentalPsychoeducational group therapy and standard treatment (ADHD treatment as usual)
Receives: Behavioral: Psychoeducational group therapy; Other: Standard treatment
Waiting listActive comparatorWaiting list and standard treatment (ADHD treatment as usual)
Receives: Behavioral: Waiting list; Other: Standard treatment

What is being measured

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

  1. Change in patient satisfaction

    Measured with a modified version of the Client Satisfaction Questionnaire (CSQ-8). The scale consists of 8 items measured on a scale from 1 to 4. A sum score between 8 and 32 indicate the level of satisfaction with services provided.

    Measured: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

  2. Change in general self-efficacy

    Measured with General Self-Efficacy Scale (GSE-6), a short-form measure of self-efficacy. Self-efficacy is regarded as a protective factor in adapting to stress and chronic illness. The scale consists of 6 items, measured on a 4-point scale, with a possible range of 6-24.

    Measured: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

Secondary outcomes (3)

  1. Change in ADHD-related symptoms (ASRS)

    Measured with ASRS, a self-reporting scale for ADHD-related symptoms in adults. The scale consists of 18 items, based on DSM-V diagnostic criteria for ADHD. The items are measured on a 5-point scale, with a possible range of 0-72.

    Measured: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

  2. Change in ADHD-related symptoms (SCL-9)

    Measured with 9 items from the SCL-90. SCL-9 is an ADHD-specific scale, consisting of 9 items of the original 90. SCL-9 covers the specific characteristic traits of ADHD.

    Measured: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

  3. Change in ADHD-related quality of life

    Measured with AAQoL - which covers ADHD-specific quality of life and function. AAQoL consists of 29 questions measuring health related quality of life among adults with ADHD.

    Measured: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

Timeline

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

  1. First posted9 Nov 2017
  2. Study start15 Nov 2017
  3. Primary completion15 Jun 2019
  4. Study completion15 Jun 2019

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
Crossover
Model description
a Norwegian multicenter study
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337425
Sponsor's protocol ID
2016/1885
Status last verified
Jul 2020
First submitted
2 Nov 2017
Last updated
16 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vaag JR, Lara-Cabrera ML, Hjemdal O, Gjervan B, Torgersen T. Psychoeducational groups versus waitlist in treatment of attention-deficit hyperactivity/impulsivity disorder (ADHD) in adults: a protocol for a pilot randomized waitlist-controlled multicenter trial. Pilot Feasibility Stud. 2019 Jan 23;5:17. doi: 10.1186/s40814-019-0401-1. eCollection 2019.

    PubMed 30693097

  • Holsbrekken A, Skliarova T, Mandahl A, Saether SG, Lund AGS, Surkovic J, Sondenaa E, Vaag J, Torgersen T, Lara-Cabrera ML. Effects of a psychoeducational group intervention for adults diagnosed with ADHD: a pilot randomized controlled study. BMC Psychiatry. 2025 Oct 14;25(1):983. doi: 10.1186/s12888-025-07452-5.

    PubMed 41088068

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducational group therapy, Waiting list and Standard treatment in people with Attention Deficit Hyperactivity Disorder, run by Norwegian University of Science and Technology at 2 sites 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 2 inclusion and 3 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 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change in patient satisfaction (time frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)). The study lists 2 primary outcomes in all. 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 NCT03337425, 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 Jul 2020.

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