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Enhancing Comprehension of Consent in Patients With Psychotic Disorders

NCT06975670 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-23

No results posted yet for this study

Summary

: 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

Conditions

Interventions

OTHER

multimedia consent tool

The multimedia consent tool is new and developed for this particular study

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Ponsiano Ochama, PhD · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2025-07-30
Completion
2025-08-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975670 on ClinicalTrials.gov