Bias, ImplicitNCT05602350
Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys
A study testing Self-administered survey and Enumerator-administered survey in people with Bias, Implicit, run by University of Chicago at 1 site in Colombia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bias, Implicit
- What is being tested?
- Self-administered survey and Enumerator-administered survey
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,500 participants
- Where
- 1 siteColombia
- Study dates
- 12 Sep 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- Female students or students not in seventh grade
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Innovations for Poverty Action
Medellín, Antioquia, 050021
Juan P Mesa, MSc, 3012898589, jpmesa@poverty-action.org
About this study
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.
- Conditions
- Bias, Implicit
- Being tested
- Self-administered survey, Enumerator-administered survey
- Medical subject headings
- Bias, Implicit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered surveyBehavioural
Subjects will self-administer questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.
Enumerator-administered surveyBehavioural
Subjects will have enumerator-administered questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Survey respondents will self-administer three survey sections in a tablet: (1) antisocial behaviors, (2) depression symptoms, and (3) anxiety symptoms Receives: Behavioral: Self-administered survey |
| Control | Placebo comparator | Survey respondents will have the survey questions on the three sections administered by an enumerator Receives: Behavioral: Enumerator-administered survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome is the mean difference in survey responses for an average of the three indexes being measured
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start12 Sep 2022
- Primary completionFeb 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bias, ImplicitStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action
- Responsible party
- Principal investigator, Christopher Blattman, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602350
- Sponsor's protocol ID
- IRB19-1212
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys
- ClinicalTrials.gov ID
- NCT05602350
- Acronym / sponsor ID
- IRB19-1212
- Conditions
- Bias, Implicit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Self-administered surveySurvey respondents will self-administer three survey sections in a tablet: (1) antisocial behaviors, (2) depression symptoms, and (3) anxiety symptoms |
| Control | Placebo comparator | Behavioral: Enumerator-administered surveySurvey respondents will have the survey questions on the three sections administered by an enumerator |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Female students or students not in seventh grade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered surveySubjects will self-administer questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety. | Behavioural | Treatment |
| Enumerator-administered surveySubjects will have enumerator-administered questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety. | Behavioural | Control |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered survey and Enumerator-administered survey in people with Bias, Implicit, run by University of Chicago at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristopher Blattman, PhD (7737028400, blattman@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022; AzTrials last refreshed its copy on 29 Oct 2026.