Big Decisions - an Evaluation of a Comprehensive Sexual Health Curriculum Pilot in Ecuador During 2019

February 18, 2022 updated by: Garrett Kneese, The University of Texas Health Science Center, Houston

Observational Studies About Implementing a Sexual Health Curriculum in Adolescents ( "Big Decisions") of the Canton Riobamba, Chimborazo - Ecuador

The purpose of this study is to assess the efficacy of the "Big Decisions" Adolescent sexual and reproductive health (ASRH) Curriculum via a pilot program with an educational experimental trial design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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 Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

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

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Student at the Liceo Policial High School in Riobamba, Ecuador(Pilot Site)
  • Student at COMIL High school in Riobamba(Control Site)
  • Student of 9th or 10th grade.

Exclusion Criteria:

  • Not a current student at the Liceo Policial High School in Riobamba, Ecuador(Pilot Site)
  • Not a current student at COMIL high school in Riobamba.(Control Site)
  • Not a student of 9th or 10th 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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Pilot Group
Other: Pilot Group
12 Weeks, 1-1 Hour Session Per Week for 10 Total Curriculum Sessions,including 1 Week of Orientation and 1 Week of Debriefing/Program Graduation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.
Time Frame: Baseline
Baseline
Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.
Time Frame: week 12
week 12
Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.
Time Frame: Baseline
Baseline
Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.
Time Frame: week 12
week 12
Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.
Time Frame: Baseline
Baseline
Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.
Time Frame: week 12
week 12
Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS)
Time Frame: Baseline
Baseline
Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS).
Time Frame: week 12
week 12
Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.
Time Frame: Baseline
Baseline
Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.
Time Frame: week 12
week 12
Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.
Time Frame: Baseline
Baseline
Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.
Time Frame: week 12
week 12
Percentage of Surveys with 100% Completion of All Questions.
Time Frame: Baseline
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
Baseline
Percentage of Surveys with 100% Completion of All Questions.
Time Frame: week 12
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
week 12
Percentage of Surveys with 100% Completion of All Questions.
Time Frame: week 16
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
week 16
Percentage of Surveys with 100% Completion of All Questions.
Time Frame: week 24
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
week 24
Number of students who abstain from participating in surveys
Time Frame: week 12
week 12
Number of students who abstain from participating in surveys
Time Frame: week 16
week 16
Number of students who abstain from participating in surveys
Time Frame: week 24
week 24
Number of students who participate in surveys
Time Frame: week 12
week 12
Number of students who participate in surveys
Time Frame: week 16
week 16
Number of students who participate in surveys
Time Frame: week 24
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National University of Chimborazo, Riobamba Ecuador

Investigators

  • Principal Investigator: Garrett Kneese, The University of Texas Health Science Center, Houston

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)

February 9, 2019

Primary Completion (Actual)

April 2, 2019

Study Completion (Actual)

April 2, 2019

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-SPH-18-0979

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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