PsychosisUBACCNCT06975670
Enhancing Comprehension of Consent in Patients With Psychotic Disorders
A study testing multimedia consent tool in people with Psychosis, run by Makerere University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychosis
- What is being tested?
- multimedia consent tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Psychotic disorders who score below 14.5 on UBACC trials.
- 18-60 years
Who cannot join
- Those participants that do not speak English or Luganda will be excluded from the study
- Hearing or Visual impairments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ENHANCING COMPREHENSION OF INFORMED CONSENT IN RESEARCH INVOLVING PATIENTS WITH PSYCHOTIC DISORDERS USING AUDIO-VISUAL AIDS
: 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.
Read more
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
Read the detailed description
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:
- Quantitative Analysis: Assessing comprehension levels using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) tool.
- Qualitative Analysis: Developing and pilot-testing a multimedia audio-visual consent tool through stakeholder consultations.
- 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.
- Conditions
- Psychosis
- Being tested
- multimedia consent tool
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimedia consent toolOther
The multimedia consent tool is new and developed for this particular study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced comprehension of consent information
Shall use the measure of the scores for the UBACC tool
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 May 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ponsiano Ochama, PhD, Study chair, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975670
- Sponsor's protocol ID
- Mak-SOMREC-2022-478
- Other IDs
- GRANT NUMBER D43TW010892)
- Acronym
- UBACC
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be deposited in the repository,
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENHANCING COMPREHENSION OF INFORMED CONSENT IN RESEARCH INVOLVING PATIENTS WITH PSYCHOTIC DISORDERS USING AUDIO-VISUAL AIDS
- ClinicalTrials.gov ID
- NCT06975670
- Acronym / sponsor ID
- UBACC / Mak-SOMREC-2022-478
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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
Detailed description
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:
- Quantitative Analysis: Assessing comprehension levels using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) tool.
- Qualitative Analysis: Developing and pilot-testing a multimedia audio-visual consent tool through stakeholder consultations.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Other: multimedia consent toolThe 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. |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Psychotic disorders who score below 14.5 on UBACC trials.
- 18-60 years
Key exclusion criteria (2 listed)
- Those participants that do not speak English or Luganda will be excluded from the study
- Hearing or Visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimedia consent toolThe multimedia consent tool is new and developed for this particular study | Other | Intervention arm |
Primary outcome
Enhanced comprehension of consent information
Time frame: 1 week
Shall use the measure of the scores for the UBACC tool
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Yes. Data will be deposited in the repository,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ponsiano Ochama, PhD study chair
Makerere University
Questions about this trial
What is this clinical trial studying?
A study testing multimedia consent tool in people with Psychosis, run by Makerere University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justine D Namuli, MMED PSYCHIATRY (+256758226440, justine_namuli@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced comprehension of consent information (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.