The Effect of a Brief Educational Intervention for Adults With ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: group-based combined with innovative technology education, Standard treatment.
- Who it may be relevant to
- Registry conditions: ADHD. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of a Brief Educational Intervention for Adults With ADHD: a Randomized Control Trial
Overview
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.
Interventions
- Behavioral 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, an - Other Standard treatment
Treatment as usual.
Primary outcome measures
- Change in client satisfaction using CSQ [Time frame: After the intervention up to 4 weeks [post intervention] and up to 56 weeks [follow up]]
- 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]]
- 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]]
- Knowledge and treatment preferences [Time frame: At baseline, 1 week before the intervention [pre-intervention], and at 4 weeks [post intervention]]
Secondary outcome measures (9)
- 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]]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Norway · 1 center
- St Olav's Hospital — Trondheim
Identifiers
NCT: NCT06284655 · 635362 a