- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05602350
Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys
October 31, 2022 updated by: Christopher Blattman, University of Chicago
Within a survey of adolescent males in Medellin schools (mainly 13-year old boys) the researchers are randomizing whether survey respondents answer sensitive questions themselves or are asked the questions by an enumerator.
Questions are of three main varieties: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
7500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cristopher Blattman, PhD
- Phone Number: 7737028400
- Email: blattman@uchicago.edu
Study Contact Backup
- Name: Santiago Tobon, PhD
- Phone Number: 7737028400
- Email: stobonz@eafit.edu.co
Study Locations
-
-
Antioquia
-
Medellin, Antioquia, Colombia, 050021
- Recruiting
- Innovations for Poverty Action
-
Contact:
- Juan P Mesa, MSc
- Phone Number: 3012898589
- Email: jpmesa@poverty-action.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- All male students in seventh grade in a sample of public schools are eligible. The sample corresponds to a representative sample of public schools (we aim at 90 schools)
Exclusion Criteria:
- Female students or students not in seventh grade
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Survey respondents will self-administer three survey sections in a tablet: (1) antisocial behaviors, (2) depression symptoms, and (3) anxiety symptoms
|
Subjects will self-administer questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.
|
Placebo Comparator: Control
Survey respondents will have the survey questions on the three sections administered by an enumerator
|
Subjects will have enumerator-administered questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The main outcome is the mean difference in survey responses for an average of the three indexes being measured
Time Frame: Through study completion, an average of 1 year
|
Three survey sections are being tested: (1) antisocial behaviors, (2) depression symptoms, and (3) anxiety symptoms.
Each section can be summarized by a single index of survey questions in that section--indexes of antisocial behavior, depression and anxiety.
To reduce the number of hypotheses tested, the researchers plan to test the difference by treatment status for an average of these three indexes.
The researchers also plan to test the mean difference by treatment status for each of the three indexes, and will report regular standard errors as well as standard errors corrected for three comparisons.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2022
Primary Completion (Anticipated)
February 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
September 23, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 2, 2022
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB19-1212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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