NCT04833972

Brief Summary

Survey experiment to elicit perceived norms about substance use

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,553

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 1, 2021

Last Update Submit

April 2, 2021

Conditions

Outcome Measures

Primary Outcomes (16)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

  • 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)

    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)

Study Arms (3)

Experimental: V1: Binary Response Options

EXPERIMENTAL

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.

Other: Survey questionnaire

Experimental: V2: Categorical Response Options

EXPERIMENTAL

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

Other: Survey questionnaire

Experimental: V3: Open-Ended Numerical Estimate

EXPERIMENTAL

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.

Other: Survey questionnaire

Interventions

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.

Experimental: V1: Binary Response OptionsExperimental: V2: Categorical Response OptionsExperimental: V3: Open-Ended Numerical Estimate

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

RECRUITING

MeSH Terms

Conditions

Tobacco UseAlcohol Drinking

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

BehaviorDrinking Behavior

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

Central Study Contacts

Alexander C Tsai, MD

CONTACT

Emily Satinsky, MSc

CONTACT

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 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.
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 6, 2021

Study Start

February 10, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations