Measuring Beliefs and Norms About Persons With Alcohol Use Disorder

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04832321
Collaborator
Mbarara University of Science and Technology (Other)
1,553
1
7
10.3
150.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Survey questionnaire
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1553 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes 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.
Primary Purpose:
Other
Official Title:
Measuring Beliefs and Norms About Persons With Alcohol Use Disorder
Actual Study Start Date :
Feb 19, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Other: Survey questionnaire
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.

Other: Survey questionnaire
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.

Other: Survey questionnaire
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.

Other: Survey questionnaire
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.

Other: Survey questionnaire
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.

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

Outcome Measures

Primary Outcome Measures

  1. Social Distance [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)

  2. Perceived Norms about Social Distance [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)

  3. Negative Attitudes (Attribution) [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)

  4. Perceived Norms about Negative Attitudes (Attribution) [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)

  5. Negative Attitudes (Shame) [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)

  6. Perceived Norms about Negative Attitudes (Shame) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mbarara University of Science and Technology Mbarara Uganda

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Mbarara University of Science and Technology

Investigators

  • Principal Investigator: Alexander C Tsai, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexander Tsai, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04832321
Other Study ID Numbers:
  • 2013P000395_1
First Posted:
Apr 5, 2021
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexander Tsai, Associate Professor of Psychiatry, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021