- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04832321
Measuring Beliefs and Norms About Persons With Alcohol Use Disorder
October 17, 2023 updated by: Alexander Tsai, Massachusetts General Hospital
Survey experiment to estimate drivers of stigma toward people with alcohol use disorder
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Despite significant advances in scientific understanding of substance use disorders accompanied by significant advances in treatment and improvements in prognosis, substance use disorder remains highly stigmatized throughout the world.
Previous studies suggest that portraying alcohol use disorder as treatable can reduce negative attitudes toward persons with alcohol use disorder.
This randomized controlled trial compares the effects of exposing study participants to vignettes portraying persons with untreated and symptomatic alcohol use disorder vs. treated alcohol use disorder with complete response vs. treated alcohol use disorder with relapse, with and without adverse economic impacts.
It is hypothesized, based on prior work, that study participants exposed to vignettes depicting treated alcohol use disorder with completed response would have the greatest effect on reducing negative attitudes toward persons with alcohol use disorder, followed by treated alcohol use disorder with relapse and untreated and symptomatic alcohol use disorder, and that adverse economic impacts will exacerbate negative attitudes toward persons with alcohol use disorder.
Study Type
Interventional
Enrollment (Actual)
1363
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Mbarara, Uganda
- Mbarara University of Science and Technology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- All adults who consider Nyakabare their primary place of residence and who are capable of providing consent
Exclusion Criteria:
- Minors younger than 18 years of age, with the exception of emancipated minors
- Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No intervention: V1: Control
This version of the survey questionnaire depicts a young man with no symptoms of alcohol use disorder
|
|
|
Experimental: Experimental: V2: Alcohol Use Disorder
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording.
This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder.
|
Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
|
|
Experimental: Experimental: V3: Alcohol Use Disorder + Treatment with Response
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording.
This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with complete response.
|
Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
|
|
Experimental: Experimental: V4: Alcohol Use Disorder + Treatment with Relapse
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording.
This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with partial relapse.
|
Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
|
|
Experimental: Experimental: V5: Alcohol Use Disorder + Economic Impact
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording.
This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances.
|
Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
|
|
Experimental: Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording.
This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with complete response.
|
Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
|
|
Experimental: Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording.
This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with partial relapse and continued negative economic impact.
|
Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Distance
Time Frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
Willingness to have the man portrayed in the vignette to marry into the study participant's family (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
|
Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
|
Perceived Norms about Social Distance
Time Frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
Study participant's perception of the extent to which other people would be willing to have the man portrayed in the vignette to marry into their families (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
|
Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
|
Negative Attitudes (Attribution)
Time Frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
Personal belief that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
|
Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
|
Perceived Norms about Negative Attitudes (Attribution)
Time Frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
|
Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
|
Negative Attitudes (Shame)
Time Frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
Personal belief that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
|
Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
|
Perceived Norms about Negative Attitudes (Shame)
Time Frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
|
Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander C Tsai, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2021
Primary Completion (Actual)
August 15, 2022
Study Completion (Actual)
August 15, 2022
Study Registration Dates
First Submitted
April 1, 2021
First Submitted That Met QC Criteria
April 2, 2021
First Posted (Actual)
April 5, 2021
Study Record Updates
Last Update Posted (Actual)
October 19, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P000395_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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