Pilot randomised controlled trial on the feasibility and intervention satisfaction with an educational group programme for adults with attention deficit hyperactivity disorder and their caregivers.
| Title: | Pilot randomised controlled trial on the feasibility and intervention satisfaction with an educational group programme for adults with attention deficit hyperactivity disorder and their caregivers. |
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| Authors: | Skliarova T; Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. tatiana.skliarova@ntnu.no.; Gråwe RW; Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.; Department of Mental Health Care, St. Olavs University Hospital, Trondheim, Norway.; Vaag J; Department of Psychology, Inland University of Applied Sciences, Lillehammer, Norway.; Mandahl A; Vårres Regional User-Led Centre Mid-Norway, Trondheim, Norway.; Kolltveit I; Department of Mental Healthcare, St. Olavs Hospital, Nidelv Community Mental Health Centre, Trondheim University Hospital, Trondheim, Norway.; Løvås I; Department of Mental Healthcare, St. Olavs Hospital, Nidelv Community Mental Health Centre, Trondheim University Hospital, Trondheim, Norway.; Torgersen T; Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.; Department of Mental Healthcare, St. Olavs Hospital, Nidelv Community Mental Health Centre, Trondheim University Hospital, Trondheim, Norway.; Lara-Cabrera ML; Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.; Department of Mental Healthcare, St. Olavs Hospital, Nidelv Community Mental Health Centre, Trondheim University Hospital, Trondheim, Norway. |
| Source: | BMC psychiatry [BMC Psychiatry] 2025 Feb 20; Vol. 25 (1), pp. 161. Date of Electronic Publication: 2025 Feb 20. |
| Publication Type: | Journal Article; Randomized Controlled Trial |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968559 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-244X (Electronic) Linking ISSN: 1471244X NLM ISO Abbreviation: BMC Psychiatry Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : BioMed Central, [2001- |
| MeSH Terms: | Attention Deficit Disorder with Hyperactivity*/therapy ; Attention Deficit Disorder with Hyperactivity*/psychology ; Caregivers*/psychology ; Caregivers*/education ; Patient Education as Topic*/methods ; Patient Satisfaction*; Humans ; Pilot Projects ; Male ; Female ; Adult ; Feasibility Studies ; Middle Aged |
| Abstract: | Background: This pilot randomised controlled trial (RCT) study presents a patient-centred educational group programme collaboratively developed with user representatives and caregivers from two organisations and health personnel from a community mental health centre (CMHC). The objectives were to investigate the feasibility of the psychoeducational programme and the satisfaction of outpatients and caregivers with programme participation. This RCT explored the potential benefits of this innovative psychoeducational programme for adults recently diagnosed with attention deficit hyperactivity disorder (ADHD).; Methods: This pilot study employed a two-arm RCT design and recruited 60 outpatients from a Norwegian CMHC. The CMHC clinicians offered the intervention group (IG) participants a two-session, patient-centred, peer-cofacilitated programme along with the standard treatment. The control group (CG) received the standard treatment and a 1-h individual informational session during the same period. The recruitment, attendance, and dropout rate indicators were assessed for feasibility. Acceptability was assessed via the Client Satisfaction Questionnaire four-item scale (CSQ-4) and a three-item scale evaluating patient satisfaction with the information provided about ADHD. In addition, four patient-reported outcome measures (PROMs) were applied: one scale to assess self-efficacy, two to assess ADHD symptoms, and one for quality of life. The statistical analysis applied intention-to-treat (ITT) and per-protocol (PP) analyses.; Results: In total, 56 outpatients were divided into the IG (n = 30) or CG (n = 26), and the recruitment rate was 93.3%, with a dropout rate of 16%. The attendance rate was 92%, and the retention rates for the IG and CG were 56.6% and 76.9%, respectively. Concerning intervention satisfaction, the ITT analysis conducted using a linear mixed model revealed statistical improvements in satisfaction, with the scale measuring satisfaction with the information and the CSQ-4 scale. In addition, caregivers expressed high satisfaction with the programme, as measured by the CSQ-4 scale. Regarding PROMs, the ITT and PP analyses yielded mixed findings.; Conclusion: Preliminary evidence indicates that a two-session, patient-centred, peer-cofacilitated psychoeducational programme is feasible and well-received, with high ratings for satisfaction from outpatients and caregivers. CLINICLATRIALS.; Gov Identifier: NCT03547843, 27/01/2022.; (© 2025. The Author(s).) |
| Competing Interests: | Declarations. Ethics approval and consent to participate: The Regional Committee for Medical Research Ethics in Mid Norway approved the study and consent form (2017/2405 REK). This project was conducted per the Declaration of Helsinki: Participation was voluntary, and written informed consent was obtained before participation. The consent form’s content was designed in close collaboration with user representatives from ADHD organisations. Moreover, all patients followed the regular assessment routines at the clinic during the study. This pilot study was submitted to ClinicalTrials.gov (NCT03547843) on April 25, 2018. Competing interests: The authors declare no competing interests. |
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| Contributed Indexing: | Keywords: Acceptability; Adult attention deficit hyperactivity disorder (ADHD); Caregivers; Patient education; Patient satisfaction; Peer-cofacilitated education; Person-centred care; Psychoeducation; Quality of life (QoL); Randomised controlled trial (RCT); Self-efficacy |
| Molecular Sequence: | ClinicalTrials.gov NCT03547843 |
| Entry Date(s): | Date Created: 20250220 Date Completed: 20250221 Latest Revision: 20250519 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC11844100 |
| DOI: | 10.1186/s12888-025-06570-4 |
| PMID: | 39979888 |
| Database: | MEDLINE |
Journal Article; Randomized Controlled Trial