NCT04832321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,363

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

April 1, 2021

Last Update Submit

October 17, 2023

Conditions

Keywords

Stigma

Outcome Measures

Primary Outcomes (6)

  • 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)

    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

    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)

    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)

    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)

    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)

    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)

Study Arms (7)

No intervention: V1: Control

NO INTERVENTION

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

Experimental: V2: Alcohol Use Disorder

EXPERIMENTAL

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

Experimental: V3: Alcohol Use Disorder + Treatment with Response

EXPERIMENTAL

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

Experimental: V4: Alcohol Use Disorder + Treatment with Relapse

EXPERIMENTAL

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

Experimental: V5: Alcohol Use Disorder + Economic Impact

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

Experimental: V2: Alcohol Use DisorderExperimental: V3: Alcohol Use Disorder + Treatment with ResponseExperimental: V4: Alcohol Use Disorder + Treatment with RelapseExperimental: V5: Alcohol Use Disorder + Economic ImpactExperimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with ResponseExperimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults who consider Nyakabare their primary place of residence and who are capable of providing consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

MeSH Terms

Conditions

AlcoholismSocial Stigma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alexander C Tsai, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

February 19, 2021

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations