ADHDNCT06284655
The Effect of a Brief Educational Intervention for Adults With ADHD
A study testing group-based combined with innovative technology education and Standard treatment in people with ADHD, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD
- What is being tested?
- group-based combined with innovative technology education and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 14 Feb 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed ADHD-diagnosis
- Speaking a Scandinavian language
- Willing to participate
Who cannot join
- Unable to give informed consent
- In-patient on a acute psychiatric ward
- Severe learning difficulties
- Involvement in other research studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St Olav's Hospital
Trondheim
Mariela Loreto Lara-Cabrera, PhD, mariela.lara@ntnu.no
About this study
Official title: The Effect of a Brief Educational Intervention for Adults With ADHD: a Randomized Control Trial
This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD.
Read the detailed description
Community mental health centres (CMHCs) face significant challenges in meeting the needs of individuals with mental health issues. For example, due to high demand there are long waiting lists and low engagement rates. To address these challenges, innovative interventions are urgently needed to improve patient engagement, coping skills, and overall health outcomes. Educational and self-management interventions have shown promise in enhancing patient satisfaction and patient activation in other contexts and may therefore be potential solutions to reduce the identified challenges in the mental health service. To bridge these knowledge and practice gaps, this application proposes the evaluation of one educational intervention tailored specifically for adults with ADHD. This intervention aims to enhance patient engagement, treatment satisfaction, activation and overall outcomes.
The main hypotheses are that the new educational approach, developed in cooperation with user representatives, will result in higher patient engagement, increase patient satisfaction with the treatment, self-efficacy and patient activation.
The researchers hypothesized that the new educational intervention, through a brief group-based approach and in conjunction with standard clinical care, will improve patients' satisfaction, patients' self-efficacy, satisfaction with the information, as well as patient activation, compared to the usual treatment, in outpatient mental health settings.
This intervention has the potential to empower patients, increase their engagement in treatment, and improve their overall functioning. By demonstrating the efficacy of this approach, this research will inform clinical practice and contribute to the optimization of care for adults with ADHD.
- Conditions
- ADHD
- Being tested
- group-based combined with innovative technology education, Standard treatment
- Keywords
- ADHD, patient education, psychoeducation, patients' satisfaction, general self-efficacy, self-management, self-management skills, group-based education, peer co-led
- 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.
group-based combined with innovative technology educationBehavioural
Also called Treatment as usual
The intervention combines brief group-based psychoeducation, and digital video- and written information, to deliver an early self-management educational program. The intervention introduces a group-breaking approach, featuring a self-managed peer co-led educational group, in collaboration with user representatives from Vårres and the ADHD organisation. This patient-centred educational programme covers crucial topics such as self-help tools, treatment options and experiences, patients' rights, and self-management, in addition to treatment as usual.
Standard treatmentOther
Treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | Patients randomized to the intervention group will start with peer co-led group-based psychoeducation, combined with digital video- and written information. Receives: Behavioral: group-based combined with innovative technology education |
| Control group | Active comparator | The control group will receive treatment as usual after randomization Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in client satisfaction using CSQ
Client satisfaction will be measured with Client Satisfaction Questionnaire 4 items (CSQ4). Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction), with higher scores indicating greater satisfaction.
Measured: After the intervention up to 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in general self-efficacy using GSE-6
General Self-Efficacy Scale is a 6-item scale with answers 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.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in satisfaction with the information
The satisfaction with the information survey includes 3 items, which score from 1 (not satisfied) to 5 (very satisfied), the option (I don't know) gives 0 points. The total score ranges from 3 to 15, with higher scores indicating higher satisfaction with the information
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Knowledge and treatment preferences
Knowledge will be measured by five questions answered on six-point ordinary scale, and one question answered as "yes", "no", "don't know"
Measured: At baseline, 1 week before the intervention [pre-intervention], and at 4 weeks [post intervention]
Secondary outcomes (9)
Change in patient activation using PAM
Patient activation will be measured with the Norwegian version of the Patient Activation Measure (PAM), which consists of 13 items, and total score ranges from 0 to 100, higher total score indicates higher patient activation
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in ADHD-related symptoms using ASRS
ADHD specific subscale and the ADHD Self-Report Scale (ASRS). Each item is answered on a five point scale ranging from 0 ("never") to 4 ("very often"). Higher scores indicates more pronounced symptoms.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in ADHD-related symptoms using SCL-9
Hopkin's Symptoms Checklist 9-items (SCL-9), consists of nine items scored from 0 ("not at all") to 4 ("very much"), and the possible total score ranges from 0 to 36. The higher score in SCL-9 indicates more pronounced symptoms of the disorder.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in depression and anxiety symptoms using PHQ-4
Patient Health Questionnaire for Depression and Anxiety (PHQ-4), consists of 4 items. Two questions assess anxiety symptoms, and two questions assess depression symptoms. Possible answers are given by a four-point scale ranging from "not at all" (0) to "nearly every day" (3), making a possible score range of 0-12. A higher score represents higher symptom severity.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in patient enablement using PEN-13
Patient Enablement-13 have 13 items. items are graded on a five/point scale and values can range from 13 (minimum enablement) to 65 points (maximum enablement).
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in stress level using PSS-4
Perceived Stress Scale 4 (PSS-4), consists of 4 items. All items are rated on an ordinal 5-point scale, coded 0 through 4, and total score ranges from 0 to 16 where a higher score represents a higher subjective stress level.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in level of functioning using WSAS
Work and Social Adjustment scale (WSAS) consists of 5 items with the range from 0 (not at all) to 8 (very severely), with the total score from 0 to 40, where the higher score indicates more severe functional impairments.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in ADHD Quality of life using AAQoL
Quality of life was measured using the Adult ADHD quality of life scale (AAQoL). The AAQoL consists of 29 questions. Each item is rated on a 1 to 5 Likert scale. The total score ranges from 0 to 100. A higher score indicates higher quality of life.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in Health-related Quality of life using EQ-5D-5L
Quality of life was measured using the 5-level EQ-5D scale (EQ-5D-5L), which consists of 5 questions, that range on 5-point scale, which reflect the level of the dimension of the functions. Higher score indicates worse quality of life.
Measured: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 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 posted29 Feb 2024
- Study start14 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Parallel groups
- Model description
- Parallel two-arms randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Mariela Loreto Lara-Cabrera, PhD, Principal investigator, Norwegian University of Science and TechnologyRolf W. Gråwe, PhD, Prof., Study chair, Norwegian University of Science and TechnologyLiv S. Engvik, Cand Psychol, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284655
- Sponsor's protocol ID
- 635362 a
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Brief Educational Intervention for Adults With ADHD: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06284655
- Acronym / sponsor ID
- 635362 a
- Conditions
- ADHD
- Keywords
- ADHD, patient education, psychoeducation, patients' satisfaction, general self-efficacy, self-management, self-management skills, group-based education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Feb 2024 (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.
This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD.
Detailed description
Community mental health centres (CMHCs) face significant challenges in meeting the needs of individuals with mental health issues. For example, due to high demand there are long waiting lists and low engagement rates. To address these challenges, innovative interventions are urgently needed to improve patient engagement, coping skills, and overall health outcomes. Educational and self-management interventions have shown promise in enhancing patient satisfaction and patient activation in other contexts and may therefore be potential solutions to reduce the identified challenges in the mental health service. To bridge these knowledge and practice gaps, this application proposes the evaluation of one educational intervention tailored specifically for adults with ADHD. This intervention aims to enhance patient engagement, treatment satisfaction, activation and overall outcomes.
The main hypotheses are that the new educational approach, developed in cooperation with user representatives, will result in higher patient engagement, increase patient satisfaction with the treatment, self-efficacy and patient activation.
The researchers hypothesized that the new educational intervention, through a brief group-based approach and in conjunction with standard clinical care, will improve patients' satisfaction, patients' self-efficacy, satisfaction with the information, as well as patient activation, compared to the usual treatment, in outpatient mental health settings.
This intervention has the potential to empower patients, increase their engagement in treatment, and improve their overall functioning. By demonstrating the efficacy of this approach, this research will inform clinical practice and contribute to the optimization of care for adults with ADHD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel two-arms randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Behavioral: group-based combined with innovative technology educationPatients randomized to the intervention group will start with peer co-led group-based psychoeducation, combined with digital video- and written information. |
| Control group | Active comparator | Other: Standard treatmentThe control group will receive treatment as usual after randomization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed ADHD-diagnosis
- Speaking a Scandinavian language
- Willing to participate
Key exclusion criteria (4 listed)
- Unable to give informed consent
- In-patient on a acute psychiatric ward
- Severe learning difficulties
- Involvement in other research studies
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 combined with innovative technology educationAlso: Treatment as usualThe intervention combines brief group-based psychoeducation, and digital video- and written information, to deliver an early self-management educational program. The intervention introduces a group-breaking approach, featuring a self-managed peer co-led educational group, in collaboration with user representatives from Vårres and the ADHD organisation. This patient-centred educational programme covers crucial topics such as self-help tools, treatment options and experiences, patients' rights, and self-management, in addition to treatment as usual. | Behavioural | Educational intervention |
| Standard treatmentTreatment as usual. | Other | Control group |
Primary outcome
Change in client satisfaction using CSQ
Time frame: After the intervention up to 4 weeks [post intervention] and up to 56 weeks [follow up]
Client satisfaction will be measured with Client Satisfaction Questionnaire 4 items (CSQ4). Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction), with higher scores indicating greater satisfaction.
Change in general self-efficacy using GSE-6
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
General Self-Efficacy Scale is a 6-item scale with answers 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.
Change in satisfaction with the information
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
The satisfaction with the information survey includes 3 items, which score from 1 (not satisfied) to 5 (very satisfied), the option (I don't know) gives 0 points. The total score ranges from 3 to 15, with higher scores indicating higher satisfaction with the information
Knowledge and treatment preferences
Time frame: At baseline, 1 week before the intervention [pre-intervention], and at 4 weeks [post intervention]
Knowledge will be measured by five questions answered on six-point ordinary scale, and one question answered as "yes", "no", "don't know"
9 secondary outcomes
Change in patient activation using PAM
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in ADHD-related symptoms using ASRS
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in ADHD-related symptoms using SCL-9
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in depression and anxiety symptoms using PHQ-4
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in patient enablement using PEN-13
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in stress level using PSS-4
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in level of functioning using WSAS
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in ADHD Quality of life using AAQoL
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in Health-related Quality of life using EQ-5D-5L
Time frame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- 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.
Mariela Loreto Lara-Cabrera, PhD principal investigator
Norwegian University of Science and Technology
Rolf W. Gråwe, PhD, Prof. study chair
Norwegian University of Science and Technology
Liv S. Engvik, Cand Psychol study chair
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 combined with innovative technology education and Standard treatment in people with ADHD, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariela Loreto Lara-Cabrera, PhD (+4748280188, mariela.lara@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in client satisfaction using CSQ (time frame: After the intervention up to 4 weeks [post intervention] and up to 56 weeks [follow up]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.