Back to resultsEliciting Perceived Norms About Substance Use
Primary Purpose
Tobacco Use, Alcohol Drinking
Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Survey questionnaire
Sponsored by
About this trial
This is an interventional other trial for Tobacco Use
Eligibility Criteria
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 TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Experimental: V1: Binary Response Options
Experimental: V2: Categorical Response Options
Experimental: V3: Open-Ended Numerical Estimate
Arm Description
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire has binary (yes/no) response options.
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire has categorical response options: all or almost all; more than half, but fewer than 90%; fewer than half, but more than 10%; very few, or no one
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire permits the study participant to provide an open-ended numerical estimate.
Outcomes
Primary Outcome Measures
Perception of Tobacco Use Frequency Among Men
"According to your perception, have most men in your cell in this parish smoked cigarettes four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Tobacco Use Frequency Among Women
"According to your perception, have most women in your cell in this parish smoked cigarettes four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Use Frequency Among Men
"According to your perception, have most men in your cell in this parish taken alcohol four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Use Frequency Among Women
"According to your perception, have most women in your cell in this parish taken alcohol four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol-Related Blackouts Among Men
"According to your perception, have most men in your cell in this parish been unable to remember what happened the night before at least once as a result of them taking alcohol in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol-Related Blackouts Among Women
"According to your perception, have most women in your cell in this parish been unable to remember what happened the night before at least once as a result of them taking alcohol in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol-Related Spousal Problems Among Men
"According to your perception, have most men in your cell in this parish quarreled after taking alcohol with their spouse or main partner if they have one in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol-Related Spousal Problems Among Women
"According to your perception, have most women in your cell in this parish quarreled after taking alcohol with their spouse or main partner if they have one in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Intoxication Among Men
"According to your perception, have most men in your cell in this parish experienced drunkenness or intoxication on 3 or more days in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Intoxication Among Women
"According to your perception, have most women in your cell in this parish experienced drunkenness or intoxication on 3 or more days in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Use Financial Harms Among Men
"According to your perception, have most men in your cell in this parish had a harmful effect on their household's finances due to them taking alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Use Financial Harms Among Women
"According to your perception, have most women in your cell in this parish had a harmful effect on their household's finances due to them taking alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Spending Among Men
"According to your perception, have most men in your cell in this parish spent more than 35,000 USh on any kind of alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Spending Among Women
"According to your perception, have most women in your cell in this parish spent more than 35,000 USh on any kind of alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Binge Use Frequency Among Men
"According to your perception, have most men in your cell in this parish taken 6 or more drinks in a single morning, afternoon, or night in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Perception of Alcohol Binge Use Frequency Among Women
"According to your perception, have most women in your cell in this parish taken 6 or more drinks in a single morning, afternoon, or night in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
Secondary Outcome Measures
Full Information
NCT ID
NCT04833972
First Posted
April 1, 2021
Last Updated
April 2, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Mbarara University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04833972
Brief Title
Eliciting Perceived Norms About Substance Use
Official Title
Eliciting Perceived Norms About Substance Use
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
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 elicit perceived norms about substance use
Detailed Description
Health behaviors and health risk behaviors are known to be associated with the extent to which one perceives these behaviors as normative. The canonical example of this phenomenon is taken from the U.S. literature, which has robustly shown that undergraduate students on college campuses tend to drink more heavily and frequently if they believe their classmates drink heavily and frequently, irrespective of their classmates' actual levels and frequency of use. However, there remains little systematic understanding about the best ways to elicit these perceived norms through survey-based research studies. This randomized survey experiment compares different ways of eliciting perceived norms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Alcohol Drinking
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 survey questions with slight changes in the wording of the response options. Neither study participants nor outcomes assessors are provided with information about "treatment" assignment.
Allocation
Randomized
Enrollment
1553 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: V1: Binary Response Options
Arm Type
Experimental
Arm Description
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire has binary (yes/no) response options.
Arm Title
Experimental: V2: Categorical Response Options
Arm Type
Experimental
Arm Description
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire has categorical response options: all or almost all; more than half, but fewer than 90%; fewer than half, but more than 10%; very few, or no one
Arm Title
Experimental: V3: Open-Ended Numerical Estimate
Arm Type
Experimental
Arm Description
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire permits the study participant to provide an open-ended numerical estimate.
Intervention Type
Other
Intervention Name(s)
Survey questionnaire
Intervention Description
Each version of the questionnaire has the same questions about perceived norms about substance use in the community but differs in how the response options are offered.
Primary Outcome Measure Information:
Title
Perception of Tobacco Use Frequency Among Men
Description
"According to your perception, have most men in your cell in this parish smoked cigarettes four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Tobacco Use Frequency Among Women
Description
"According to your perception, have most women in your cell in this parish smoked cigarettes four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol Use Frequency Among Men
Description
"According to your perception, have most men in your cell in this parish taken alcohol four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol Use Frequency Among Women
Description
"According to your perception, have most women in your cell in this parish taken alcohol four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol-Related Blackouts Among Men
Description
"According to your perception, have most men in your cell in this parish been unable to remember what happened the night before at least once as a result of them taking alcohol in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 30 days)
Title
Perception of Alcohol-Related Blackouts Among Women
Description
"According to your perception, have most women in your cell in this parish been unable to remember what happened the night before at least once as a result of them taking alcohol in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 30 days)
Title
Perception of Alcohol-Related Spousal Problems Among Men
Description
"According to your perception, have most men in your cell in this parish quarreled after taking alcohol with their spouse or main partner if they have one in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 30 days)
Title
Perception of Alcohol-Related Spousal Problems Among Women
Description
"According to your perception, have most women in your cell in this parish quarreled after taking alcohol with their spouse or main partner if they have one in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 30 days)
Title
Perception of Alcohol Intoxication Among Men
Description
"According to your perception, have most men in your cell in this parish experienced drunkenness or intoxication on 3 or more days in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 30 days)
Title
Perception of Alcohol Intoxication Among Women
Description
"According to your perception, have most women in your cell in this parish experienced drunkenness or intoxication on 3 or more days in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 30 days)
Title
Perception of Alcohol Use Financial Harms Among Men
Description
"According to your perception, have most men in your cell in this parish had a harmful effect on their household's finances due to them taking alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol Use Financial Harms Among Women
Description
"According to your perception, have most women in your cell in this parish had a harmful effect on their household's finances due to them taking alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol Spending Among Men
Description
"According to your perception, have most men in your cell in this parish spent more than 35,000 USh on any kind of alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol Spending Among Women
Description
"According to your perception, have most women in your cell in this parish spent more than 35,000 USh on any kind of alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol Binge Use Frequency Among Men
Description
"According to your perception, have most men in your cell in this parish taken 6 or more drinks in a single morning, afternoon, or night in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
Title
Perception of Alcohol Binge Use Frequency Among Women
Description
"According to your perception, have most women in your cell in this parish taken 6 or more drinks in a single morning, afternoon, or night in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options)
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, and participants are asked about the past 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander C Tsai, MD
Phone
617-724-1120
Email
actsai@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Satinsky, MSc
Phone
617-724-1120
Email
esatinsky@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander C Tsai, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Kakuhikire, MBA
Phone
256-075-250-4030
Email
baitwakaku@gmail.com
First Name & Middle Initial & Last Name & Degree
Charles Baguma, MPH
Phone
256-077-564-1558
Email
cbaguma@mustresearch.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Eliciting Perceived Norms About Substance Use
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