Measuring Beliefs and Norms About Persons With Alcohol Use Disorder

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Uganda

Study Type

Interventional

Intervention

Survey questionnaire

About this trial

This is an interventional other trial for Alcohol Use Disorder (AUD) focused on measuring Stigma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Mbarara University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Experimental

Arm Label

No intervention: V1: Control

Experimental: V2: Alcohol Use Disorder

Experimental: V3: Alcohol Use Disorder + Treatment with Response

Experimental: V4: Alcohol Use Disorder + Treatment with Relapse

Experimental: V5: Alcohol Use Disorder + Economic Impact

Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response

Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse

Arm Description

This version of the survey questionnaire depicts a young man with no symptoms of 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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Social Distance

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)

Perceived Norms about Social Distance

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)

Negative Attitudes (Attribution)

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)

Perceived Norms about Negative Attitudes (Attribution)

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)

Negative Attitudes (Shame)

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)

Perceived Norms about Negative Attitudes (Shame)

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04832321

First Posted

April 1, 2021

Last Updated

October 17, 2023

Sponsor

Massachusetts General Hospital

Collaborators

Mbarara University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT04832321

Brief Title

Measuring Beliefs and Norms About Persons With Alcohol Use Disorder

Official Title

Measuring Beliefs and Norms About Persons With Alcohol Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

February 19, 2021 (Actual)

Primary Completion Date

August 15, 2022 (Actual)

Study Completion Date

August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Mbarara University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

Survey experiment to estimate drivers of stigma toward people with alcohol use disorder

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder (AUD)

Keywords

Stigma

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Study participants are randomly assigned to be read vignettes with slight changes in wording. Neither study participants nor outcomes assessors are provided with information about "treatment" assignment.

Allocation

Randomized

Enrollment

1363 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No intervention: V1: Control

Arm Type

No Intervention

Arm Description

This version of the survey questionnaire depicts a young man with no symptoms of alcohol use disorder

Arm Title

Experimental: V2: Alcohol Use Disorder

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental: V3: Alcohol Use Disorder + Treatment with Response

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental: V4: Alcohol Use Disorder + Treatment with Relapse

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental: V5: Alcohol Use Disorder + Economic Impact

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Survey questionnaire

Intervention Description

Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.

Primary Outcome Measure Information:

Title

Social Distance

Description

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)

Time Frame