NCT05602350

Brief 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. Questions are of three main varieties: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.

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
7,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

September 23, 2022

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 1 year

Study Arms (2)

Treatment

EXPERIMENTAL

Survey respondents will self-administer three survey sections in a tablet: (1) antisocial behaviors, (2) depression symptoms, and (3) anxiety symptoms

Behavioral: Self-administered survey

Control

PLACEBO COMPARATOR

Survey respondents will have the survey questions on the three sections administered by an enumerator

Behavioral: Enumerator-administered survey

Interventions

Subjects will self-administer questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.

Treatment

Subjects will have enumerator-administered questionnaire sections on sensitive topics: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.

Control

Eligibility Criteria

Age9 Years - 16 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Female students or students not in seventh grade

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action

Medellín, Antioquia, 050021, Colombia

RECRUITING

MeSH Terms

Conditions

Bias, Implicit

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehavior

Central Study Contacts

Cristopher Blattman, PhD

CONTACT

Santiago Tobon, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ramalee E. Pearson Professor of Global Conflict Studies

Study Record Dates

First Submitted

September 23, 2022

First Posted

November 2, 2022

Study Start

September 12, 2022

Primary Completion

February 1, 2023

Study Completion

September 1, 2023

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations