Attention Deficit Disorder With HyperactivityADHDNCT03547843
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder
A study testing Group-based education, Waiting list and Standard treatment in people with Attention Deficit Disorder With Hyperactivity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Group-based education, Waiting list and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNorway
- Study dates
- 31 May 2018to 15 Mar 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 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
- Unable to give informed consent
- Psychosis
- Severe learning difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder
Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD).
This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.
- Being tested
- Group-based education, Waiting list, Standard treatment
- Keywords
- Behavior therapy, Peer groups, Patient satisfaction, Feasibility studies
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based educationBehavioural
Also called Patient education
The group-based educational program consists of two sessions that run over two consecutive weeks. Each session consists of a lecture from a recruited expert on the topic of the session and by expert patients with a following discussion of the topic facilitated by the course leader.
Waiting listBehavioural
No educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment.
Standard treatmentOther
Also called Treatment as usual
Diagnostic treatment with medication. In addition, some patients receive cognitive behavioral therapy (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 group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization. Receives: Behavioral: Group-based education; Other: Standard treatment |
| Waiting list | Active comparator | Participants randomized to the waiting list control group receive no educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment, consisting of diagnostic treatment with medication. Receives: Behavioral: Waiting list; Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in client Satisfaction
Client satisfaction will be measured with Client Satisfaction Questionnaire, short form (Attkisson \& Zwick, 1982). The scale consists of 8 items scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Measured: from baseline to 2-weeks follow-up
change in patient activation
Patient activation will be measured with the Norwegian version of the Patient Activation Measure Mental Health (PAM-MH) (Green et al 2010))
Measured: from baseline to 10-weeks follow-up
Secondary outcomes (4)
change in general self-efficacy
General Self-Efficacy Scale, 6-item scale ranging from 1 ('not at all true') to 4 ('exactly true'). Total scores range from 6 to 24, with higher scores indicating greater self-efficacy. (Romppel et al 2013)
Measured: from baseline to 10 weeks follow-up
change in ADHD-related symptoms
Hopkin's Symptom Checklist (SCL), 9-items scale with high scores on SCL-9 indicating ADHD-related symptom burden (Eich et al 2011)
Measured: from baseline to 10 weeks follow-up
change in ADHD-related symptoms
Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)
Measured: from baseline to 10 weeks follow-up
change in Quality of Life
Adult Attention Deficit/Hyperactivity Disorder Quality of Life Scale, AAQoL short Form (Brod et al 2006)
Measured: from baseline to 10 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start31 May 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Anne-Lise Løvaas, md phd, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547843
- Sponsor's protocol ID
- 2017/2405 REK
- Acronym
- ADHD
- Status last verified
- Aug 2021
- First submitted
- 25 Apr 2018
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skliarova T, Grawe RW, Vaag J, Mandahl A, Kolltveit I, Lovas I, Torgersen T, Lara-Cabrera ML. Pilot randomised controlled trial on the feasibility and intervention satisfaction with an educational group programme for adults with attention deficit hyperactivity disorder and their caregivers. BMC Psychiatry. 2025 Feb 20;25(1):161. doi: 10.1186/s12888-025-06570-4.
PubMed 39979888
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder
- ClinicalTrials.gov ID
- NCT03547843
- Acronym / sponsor ID
- ADHD / 2017/2405 REK
- Keywords
- Behavior therapy, Peer groups, Patient satisfaction, Feasibility studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 31 May 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD).
This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Behavioral: Group-based education, Other: Standard treatmentPatients randomized to the intervention group will start with a group-based educational program immediately after the randomization. |
| Waiting list | Active comparator | Behavioral: Waiting list, Other: Standard treatmentParticipants randomized to the waiting list control group receive no educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment, consisting of diagnostic treatment with medication. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed ADHD-diagnosis
- speaking a Scandinavian language
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Psychosis
- Severe learning difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based educationAlso: Patient educationThe group-based educational program consists of two sessions that run over two consecutive weeks. Each session consists of a lecture from a recruited expert on the topic of the session and by expert patients with a following discussion of the topic facilitated by the course leader. | Behavioural | Educational intervention |
| Waiting listNo educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment. | Behavioural | Waiting list |
| Standard treatmentAlso: Treatment as usualDiagnostic treatment with medication. In addition, some patients receive cognitive behavioral therapy (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. | Other | Educational intervention, Waiting list |
Primary outcome
Change in client Satisfaction
Time frame: from baseline to 2-weeks follow-up
Client satisfaction will be measured with Client Satisfaction Questionnaire, short form (Attkisson \& Zwick, 1982). The scale consists of 8 items scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
change in patient activation
Time frame: from baseline to 10-weeks follow-up
Patient activation will be measured with the Norwegian version of the Patient Activation Measure Mental Health (PAM-MH) (Green et al 2010))
4 secondary outcomes
change in general self-efficacy
Time frame: from baseline to 10 weeks follow-up
change in ADHD-related symptoms
Time frame: from baseline to 10 weeks follow-up
change in ADHD-related symptoms
Time frame: from baseline to 10 weeks follow-up
change in Quality of Life
Time frame: from baseline to 10 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 39979888Skliarova T, Grawe RW, Vaag J, Mandahl A, Kolltveit I, Lovas I, Torgersen T, Lara-Cabrera ML. Pilot randomised controlled trial on the feasibility and intervention satisfaction with an educational group programme for adults with attention deficit hyperactivity disorder and their caregivers. BMC Psychiatry. 2025 Feb 20;25(1):161. doi: 10.1186/s12888-025-06570-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Lise Løvaas, md phd study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based education, Waiting list and Standard treatment in people with Attention Deficit Disorder With Hyperactivity, run by Norwegian University of Science and Technology 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 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 27 Jan 2022. 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?
Change in client Satisfaction (time frame: from baseline to 2-weeks follow-up). 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 NCT03547843, which also lists 1 linked publication.
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 27 Jan 2022.