Enhancing Comprehension of Consent in Patients With Psychotic Disorders

NCT06975670 | Not Yet Recruiting DMC

• 2 other identifiers: Mak-SOMREC-2022-478GRANT NUMBER D43TW010892)
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Psychosis

Outcome Measures

Primary Outcomes (1)

• Enhanced comprehension of consent information

  Shall use the measure of the scores for the UBACC tool

  1 week

Study Arms (2)

Intervention arm

OTHER

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

control arm

NO INTERVENTION

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

Interventions

multimedia consent tool OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Psychotic disorders who score below 14.5 on UBACC trials.
• years

You may not qualify if:

• Those participants that do not speak English or Luganda will be excluded from the study
• Hearing or Visual impairments

Sponsors & Collaborators

• Makerere University: lead

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Ponsiano Ochama, PhD

  Makerere University

  STUDY CHAIR

Central Study Contacts

Justine D Namuli, MMED PSYCHIATRY

CONTACT

+256758226440; justine_namuli@yahoo.com

Harriet N Nambooze, social works(SWASA)

CONTACT

+256777504301; hnambooze@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: They will not know the arm that the patient belonged to during asssesment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To randomize participants into two consent arms. The control arm are those who will be given routine traditional paper consent, then the intervention arm, those who will be given a multimedia consent tool and assess if their is improvement in comprehension

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: May 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: As advised