Enhancing Comprehension of Consent in Patients With Psychotic Disorders

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: 1. Quantitative Analysis: Assessing comprehension levels using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) tool. 2. Qualitative Analysis: Developing and pilot-testing a multimedia audio-visual consent tool through stakeholder consultations. 3. Comparative Analysis: Conducting a randomized pilot study to compare the effectiveness of routine paper consent with multimedia audio-visual consent. 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.