protocolSection identificationModule nctId: NCT06284655, orgStudyIdInfo id: 635362 a, briefTitle: The Effect of a Brief Educational Intervention for Adults With ADHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: St. Olavs Hospital, class: OTHER, collaborators name: Norwegian University of Science and Technology, descriptionModule briefSummary: 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., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel two-arms randomized control trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Blinded statistician, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: group-based combined with innovative technology education, interventions name: Standard treatment, outcomesModule primaryOutcomes measure: Change in client satisfaction using CSQ, primaryOutcomes measure: Change in general self-efficacy using GSE-6, primaryOutcomes measure: Change in satisfaction with the information, primaryOutcomes measure: Knowledge and treatment preferences, secondaryOutcomes measure: Change in patient activation using PAM, secondaryOutcomes measure: Change in ADHD-related symptoms using ASRS, secondaryOutcomes measure: Change in ADHD-related symptoms using SCL-9, secondaryOutcomes measure: Change in depression and anxiety symptoms using PHQ-4, secondaryOutcomes measure: Change in patient enablement using PEN-13, secondaryOutcomes measure: Change in stress level using PSS-4, secondaryOutcomes measure: Change in level of functioning using WSAS, secondaryOutcomes measure: Change in ADHD Quality of life using AAQoL, secondaryOutcomes measure: Change in Health-related Quality of life using EQ-5D-5L, otherOutcomes measure: Cost, otherOutcomes measure: Health care usage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Olav's Hospital, city: Trondheim, country: Norway, contacts name: Mariela Loreto Lara-Cabrera, PhD, role: CONTACT, email: mariela.lara@ntnu.no, geoPoint lat: 63.43049, lon: 10.39506, hasResults: False