Clinical trial NCT06284655: The Effect of a Brief Educational Intervention for Adults With ADHD
Official title: The Effect of a Brief Educational Intervention for Adults With ADHD: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ADHD
Keywords: ADHD
patient education
psychoeducation
patients' satisfaction
general self-efficacy
self-management
self-management skills
group-based education
peer co-led
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2024-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel two-arms randomized control trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in client satisfaction using CSQ
timeFrame: After the intervention up to 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in general self-efficacy using GSE-6
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in satisfaction with the information
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Knowledge and treatment preferences
timeFrame: At baseline, 1 week before the intervention [pre-intervention], and at 4 weeks [post intervention]
Secondary outcomes:
measure: Change in patient activation using PAM
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in ADHD-related symptoms using ASRS
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in ADHD-related symptoms using SCL-9
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in depression and anxiety symptoms using PHQ-4
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in patient enablement using PEN-13
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in stress level using PSS-4
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in level of functioning using WSAS
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in ADHD Quality of life using AAQoL
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
measure: Change in Health-related Quality of life using EQ-5D-5L
timeFrame: At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Other outcomes:
measure: Cost
timeFrame: Up to 56 weeks [follow up]
measure: Health care usage
timeFrame: Up to 56 weeks [follow up]
Locations:
city: Trondheim
country: Norway
facility: St Olav's Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Mariela Loreto Lara-Cabrera, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Rolf W. Gråwe, PhD, Prof.
role: STUDY_CHAIR
affiliation: St. Olavs Hospital
name: Liv S. Engvik, Cand Psychol
role: STUDY_CHAIR
References: