An interventional study of multimedia consent tool in Psychosis, sponsored by Makerere University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Makerere University · Not applicable, Interventional, and Other
: Informed consent is an important aspect of research, however in psychiatry research it remains an ethical dilemma, for the lack of clarity on the consent process deters some researchers from mental health research, and yet a good research must ensure that this moral stand is undertaken. Studies that literally test measures that improve the informed consent process in participants with psychotic disorders have been scanty. To date, there is a noticeable absence of an evidence-based intervention for enhancing the comprehension of consent information in research participants with psychotic disorders in the Ugandan context. Thus, this research study is to explore methods like incorporating multimedia components, such as audio and visual aids, to enhance the participants' grasp of research particulars, thereby enabling them to make informed decisions effectively and give informed consent when they are invited to participate in research projects.
Objective: To evaluate the comprehension of informed consent, identify key factors that that are associated with comprehension of consent, and determine the feasibility, acceptability, and preliminary effectiveness of audio-visual aids on enhancing the comprehension of consent information during the consenting process in research involving individuals with psychotic disorders.
Methods: This will be a multi-method research design that will be achieved through four sub-studies. Sub-study 1 will be cross-sectional and will involve an assessment of comprehension of informed consent using the University of California Brief Assessment of Capacity to Consent (UBACC) tool. Participants will be patients aged 18- 60 years with a psychotic disorder. Sub-study 2 will be a qualitative study that utilizes a user-centered design approach by engaging a multidisciplinary team of stakeholders to develop a multimedia audio-visual consent tool.
Sub-study 3 will be a randomized pilot study designed to evaluate the effectiveness of the multimedia video consent tool and how it compares with the traditional paper method in enhancing participants' comprehension of consent information.
Sub-study 4 will be a mixed-methods approach using quantitative and qualitative data from exit interviews to assess the Feasibility and Acceptability of the audio-visual consent tool for individuals with psychotic disorders and the research assistants administering the tool in a mental health research setting
Scope of the Study Depth of Investigation
The study aims to evaluate the comprehension of informed consent among participants with psychotic disorders using quantitative methods. It is also set to develop and evaluate the effectiveness of audio-visual aids in enhancing comprehension of consent research information compared to traditional paper-based consent methods using both qualitative and quantitative methods. The investigation involves:
Content The study content encompasses the development of a multimedia audio-visual consent tool, informed by input from a multidisciplinary team, including mental health professionals, ethicists, Information technologists and participants' representatives. It involves the application of multi-method research design, integrating both descriptive and thematic analyses, as well as statistical evaluations using logistic regression and mixed-effects linear regression models.
Sample Size The study will involve participants diagnosed with psychotic disorders who are engaged in mental health services in Butabika National Referral Psychiatric Hospital in Uganda, hereafter referred to as Butabika Hospital A representative sample size will be determined based on power calculations to ensure the reliability and validity of the findings.
Geographical Coverage The research will be conducted in Uganda, specifically focusing on in-patients and outpatients with a psychotic disorder at Butabika Hospital who will be present during the study period and fulfill the selection criteria. This geographical focus allows for an examination of context-specific challenges and opportunities in the consent process.
Time Frame The study is designed to be conducted over a period of two years, allowing for comprehensive data collection, tool development, pilot testing, and analysis. This time frame ensures thorough investigation and iterative refinement of the consent process and materials.
Theoretical Coverage The study is grounded on the cognitive theory of multimedia learning and dual coding together with ethical principle that emphasize autonomy and informed consent in mental health research. It draws on these theories to explore how multimedia tools can enhance comprehension, thus decision-making among participants with psychotic disorders.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
The 30 participants assigned to the multimedia consent, which is the intervention arm, will first meet individually with a trained research assistant who will provide a video that explains the protocol and encourage them to watch it. Subjects will be encouraged to have the RA stop the multimedia consent video and repeat any segments that are unclear. Participants will also be encouraged to discuss and clarify issues with the RAs (and not simply have the video rerun). Having such a discussion is vital in that, much as multimedia consent aids appear to be more effective as aids, they should not be viewed as substitutes for person-to-person interaction(Flory \& Emanuel, 2004). In order to control for social element consent enhancement, the role of the RA will be emphasized that he or she is meant to guide the participant, not educating them. The RA will record duration of time the consent will takes for each participant, so that we compare time spent in each consent condition.
Other: multimedia consent tool
The 30 participants assigned to the routine paper consent procedure which is the control arm, will first meet individually with a trained research assistant who will provide the subjects with the printed consent form and encourage them to read along while the research assistant (RA) read it aloud. Participants will be motivated to stop the RA and seek for clarification any time during the consent process. To control for social element consent enhancement, the role of the RA will be emphasized that he or she is meant to guide the participant, not educating them. The RA will record duration of time the consent will take for each participant, so that we compare time spent in each consent condition
The multimedia consent tool is new and developed for this particular study
Enhanced comprehension of consent information
Shall use the measure of the scores for the UBACC tool
Time frame: 1 week
No study locations are listed for this record.
Plan to share: Yes — Data will be deposited in the repository,
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: As advised
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Jul 2025, 2 months later.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 2 months is below that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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