The Effect of a Brief Educational Intervention for Adults With ADHD

NCT ID: NCT06284655

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2030-12-31

Brief 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). 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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Educational intervention

Patients randomized to the intervention group will start with peer co-led group-based psychoeducation, combined with digital video- and written information.

Group Type: EXPERIMENTAL

group-based combined with innovative technology education

Intervention Type: BEHAVIORAL

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.

Control group

The control group will receive treatment as usual after randomization

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: OTHER

Treatment as usual.

Interventions

group-based combined with innovative technology education

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.

Intervention Type: BEHAVIORAL

Standard treatment

Treatment as usual.

Intervention Type: OTHER

Other Intervention Names

Treatment as usual

Eligibility Criteria

Inclusion Criteria

• Confirmed ADHD-diagnosis
• Speaking a Scandinavian language
• Willing to participate

Exclusion Criteria

• Unable to give informed consent
• In-patient on a acute psychiatric ward
• Severe learning difficulties
• Involvement in other research studies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariela Loreto Lara-Cabrera, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Rolf W. Gråwe, PhD, Prof.

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Liv S. Engvik, Cand Psychol

Role: STUDY_CHAIR

St. Olavs Hospital

Locations

St Olav's Hospital

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Mariela Loreto Lara-Cabrera, PhD

Role: CONTACT

mariela.lara@ntnu.no

+4748280188

Tatiana Skliarova, MD

Role: CONTACT

tatiana.skliarova@ntnu.no

+4748637421

Facility Contacts

Mariela Loreto Lara-Cabrera, PhD

Role: primary

mariela.lara@ntnu.no

Other Identifiers

635362 a

Identifier Type: -

Identifier Source: org_study_id