The Effect of a Brief Educational Intervention for Adults With ADHD

NCT06284655 | Recruiting

• 1 other identifier: 635362 a
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; patient education; psychoeducation; patients' satisfaction; general self-efficacy; self-management; self-management skills; group-based education; peer co-led

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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"

  At baseline, 1 week before the intervention [pre-intervention], and at 4 weeks [post intervention]

Secondary Outcomes (9)

• Change in patient activation using PAM

  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

  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

  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

  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

  At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Other Outcomes (2)

• Cost

  Up to 56 weeks [follow up]

• Health care usage

  Up to 56 weeks [follow up]

Study Arms (2)

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.

Behavioral: group-based combined with innovative technology education

Control group

ACTIVE COMPARATOR

The control group will receive treatment as usual after randomization

Other: Standard treatment

Interventions

group-based combined with innovative technology education 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.

Also known as: Treatment as usual

Educational intervention

Standard treatment OTHER

Treatment as usual.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olav's Hospital

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mariela Loreto Lara-Cabrera, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Rolf W. Gråwe, PhD, Prof.

  Norwegian University of Science and Technology

  STUDY CHAIR

• Liv S. Engvik, Cand Psychol

  St. Olavs Hospital

  STUDY CHAIR

Central Study Contacts

Mariela Loreto Lara-Cabrera, PhD

CONTACT

+4748280188; mariela.lara@ntnu.no

Tatiana Skliarova, MD

CONTACT

+4748637421; tatiana.skliarova@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded statistician
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel two-arms randomized control trial

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: February 29, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)